Radiofrequency neurotomy of the cervical & lumbar medial … · 2019-03-27 · ACC Research:...

Radiofrequency neurotomy of the cervical & lumbar medial branches: evidence based review

September 2015

Requested by: IPM Expert Group

Business group: Clinical Services Directorate

Date requested: December 2014

Date completed: October 2015

Author Amanda Bowens

Status: Final

Version Final

ACC Research: Evidence Based Healthcare Review of 42

Important note

The purpose of this report is to outline and interpret the best current evidence for the effectiveness of

radiofrequency neurotomy (RFN) of the cervical and lumbar medial branches in the treatment of persistent

neck or back pain.

It is not intended to replace clinical judgement or be used as a clinical protocol.

A reasonable attempt has been made to find and review papers relevant to the focus of this report;

however, it does not claim to be exhaustive.

This document has been prepared by the staff of the Evidence Based Healthcare Team, ACC Research.

The content does not necessarily represent the official view of ACC or represent ACC policy.

This report is based upon information supplied up to end September 2015.


Table of Contents

Executive summary .................................................................................................................................................... 5

1 Background ..................................................................................................................................................... 6

1.1 Objective of this review ................................................................................................................................. 6

1.2 ACC’s current position on RFN ..................................................................................................................... 6

1.3 Description of RFN ........................................................................................................................................ 7

2 Methods ........................................................................................................................................................... 7

2.1 Literature search ........................................................................................................................................... 7

2.2 Study selection .............................................................................................................................................. 7

Inclusion criteria ...................................................................................................................................... 7 2.2.1

Exclusion criteria ..................................................................................................................................... 7 2.2.2

2.3 Evidence grading .......................................................................................................................................... 8

3 Findings ........................................................................................................................................................... 8

3.1 Studies identified ........................................................................................................................................... 8

3.2 Critical appraisal: effectiveness .................................................................................................................... 9

Cervical RFN ........................................................................................................................................... 9 3.2.1

Lumbar RFN .......................................................................................................................................... 10 3.2.2

3.3 Critical appraisal: safety .............................................................................................................................. 11

3.4 Information from other guidelines & sources not meeting the criteria for critical appraisal ........................ 11

Cervical RFN ......................................................................................................................................... 11 3.4.1

Lumbar RFN .......................................................................................................................................... 12 3.4.2

Overseas insurer policies on funding RFN ........................................................................................... 13 3.4.3

4 Discussion ..................................................................................................................................................... 14

4.1 Nature and quality of the evidence ............................................................................................................. 14

Cervical RFN ......................................................................................................................................... 14 4.1.1

Lumbar RFN .......................................................................................................................................... 14 4.1.2

Safety and adverse events ................................................................................................................... 15 4.1.3

Importance of diagnostic selection criteria and RFN technique ........................................................... 15 4.1.4

4.2 Limitations of this review ............................................................................................................................. 16

5 Conclusions .................................................................................................................................................. 16

5.1 Evidence statements................................................................................................................................... 16

5.2 Implications for practice and purchasing .................................................................................................... 17

5.3 Purchasing recommendations .................................................................................................................... 17

6 References ..................................................................................................................................................... 18

7 Appendices .................................................................................................................................................... 22

7.1 Search Strategy .......................................................................................................................................... 22

7.2 Excluded studies ......................................................................................................................................... 23


7.3 Systematic reviews & guidelines – what studies do they cover? Cervical ................................................. 24

7.4 Systematic reviews & guidelines – what studies do they cover? Lumbar .................................................. 25

7.5 Systematic reviews (SRs) & SR-based guidelines – evidence tables: cervical .......................................... 26

7.6 Systematic reviews (SRs) & SR-based guidelines – evidence tables: lumbar ........................................... 31

7.7 Other clinical practice guidelines – summary table: cervical ...................................................................... 40

7.8 Other clinical practice guidelines – summary table: lumbar ....................................................................... 41


Executive summary

Background

This review assesses the evidence for radiofrequency neurotomy (RFN) of the cervical and lumbar medial

branches as a treatment for persistent neck and lower back pain in order to update the purchasing

recommendations made in 2005 as part of ACC’s online interventional Pain Management (IPM) guidance.

Methods

Systematic reviews identified via a comprehensive database search and selected according to stated criteria were

critically appraised using the SIGN levels of evidence model.

Findings

Ten systematic reviews were included in the critical appraisal. A number of other evidence sources, e.g. clinical

guidelines and New Zealand based primary studies, were also considered. Overall the systematic reviews were

well conducted and the quality of the primary studies was moderate.

Conclusions

The evidence base for cervical RFN has not changed significantly since 2005. The evidence base for lumbar RFN

has increased in terms of numbers of randomised controlled trials, but their quality and findings vary. Careful

patient selection based on accurate diagnosis appears central to the success of these interventions.

Recommendations

It is recommended that ACC continues to purchase these interventions on a case by case basis where stated

criteria, including patient selection, are met.


1 Background 1.1 Objective of this review

The objective is to update ACC’s current purchasing recommendations on radiofrequency neurotomy (RFN) of the

cervical and lumbar medial branches. The recommendations were released in 2005 as part of the online

Interventional Pain Management (IPM) guidance. This review will carry out a pragmatic assessment of the best

available recent evidence to determine whether the recommendations need to change.

The updated purchasing recommendations will be used to support ACC clinical advisors in making decisions about

managing clients with persistent pain. They will also be presented to the ACC Purchasing Guidance Advisory

Group (PGAG) in order to develop purchasing guidance for the business.

In order to update the purchasing recommendations, this review aims to answer the following research questions:

1. What is the evidence for the effectiveness of RFN in relieving persistent neck or back pain originating from the

cervical or lumbar facet joints?

2. What is the evidence for the effects of RFN on functional outcomes (e.g. quality of life, return to work) in people

with these types of persistent pain?

3. What is the evidence for the safety of RFN interventions?

1.2 ACC’s current position on RFN

The full clinical practice and purchasing recommendations are available on the IPM website – see the intervention

pages for RFN cervical medial branch and RFN lumbar medial branch. They are summarised below.

Table 1: ACC’s current recommendations on medial branch RFN

ACC funding of RFN has now extended beyond the research setting and a number of providers are contracted to

offer this service. Since 2008, around 370 clients have received ACC-funded cervical or lumbar medial branch

RFN. These procedures currently cost around $5,000 - $5,500 excluding GST.

Clinical practice recommendations Purchasing recommendations

RFN cervical

medial branch:

used to treat

persistent neck

pain

RFN of the cervical medial branch should only be performed in a research setting (grade of recommendation = B, supported by fair evidence).

Purchase RF neurotomy of the cervical medial branch on a case by case basis in those centres, with specifically trained personnel, where protocols are currently in place and which collect procedural data that is available to guide ACC in future purchasing decisions.

RFN lumbar

medial branch:

used to treat

persistent low

back pain

The general use of RFN of the lumbar medial branch is not recommended for the treatment of adults with lower back pain. However, the procedure may be considered in the research setting (grade of recommendation = C, supported by expert opinion only).

Purchase RF neurotomy of the lumbar medial branch on a case by case basis in those centres, with specifically trained personnel, where protocols are currently in place and which collect procedural data that is available to guide ACC in future purchasing decisions.

Good practice

points

Double-blind, comparative, diagnostic cervical or lumbar medial branch blocks are an essential pre-requisite before these interventions are considered

The technique used for cervical RFN should conform with the practice guidelines laid down by the International Spine Intervention Society (ISIS)1


1.3 Description of RFN

RFN is an outpatient procedure that can be used to treat persistent neck or back pain. A needle inserted beside a

spinal nerve has current passed through it to produce heat and coagulate the nerve proteins. Successful treatment

temporarily prevents the nerve from conducting pain impulses. As nerves eventually recover, pain relief following

RFN may be time limited and the procedure may need to be repeated. Recovery of the nerve typically takes about

a year. There is limited evidence on the duration of pain relief and the outcome of repeat RFN2.

This review focuses on RFN of the medial branches of the cervical and lumbar dorsal rami. These provide the

nerve supply to the facet (also known as the zygapophyseal or z-) joints of the cervical and lumbar spine. RFN is

applied to the medial branches to treat neck or low back pain originating from cervical or lumbar facet joints. Each

facet joint (except C2-3) is supplied by two medial branches and therefore two nerves have to be treated in order to

relieve pain originating from one joint. The procedure is performed under X-ray guidance.

Before RFN is performed, diagnostic nerve blocks should be carried out to ensure that the facet joints are indeed

the source of the pain. Facet joints are a more common source of neck pain than back pain: cervical facet joints

have been estimated to be the source of 50-60% of trauma-related chronic neck pain3 but only 30% of chronic back

pain overall; the percentage is lower (about 15%) in young adults, but increases with age4.

2 Methods 2.1 Literature search

A search of the following databases was conducted in December 2014:

Cochrane Library

Embase

Medline & Pre-Medline

Trip database

Auto alerts were run on Medline and Embase to ensure that studies added to the databases whilst the review was

in progress were picked up. See the Appendix (section 7.1) for the search strategy.

2.2 Study selection

This review is intended as a pragmatic assessment of the best recent evidence. It therefore has tighter inclusion

criteria than those used for the 2005 IPM guidance and focuses on secondary research. Due to the relatively high

number of secondary studies identified, the decision was taken to set 2010 as the cut off publication date:

Inclusion criteria 2.2.1

Study types: systematic reviews (SRs) of randomised controlled trials (RCTs) or other primary studies with

or without meta-analysis; health technology assessments (HTAs) or clinical guidelines based on SRs

Participants: adults with persistent neck or back pain of cervical or lumbar facet joint origin

Intervention: conventional thermal RFN of the cervical or lumbar medial branches

Controls: any active treatment or placebo, e.g. sham treatment

Outcomes: pain relief (primary) and functional (secondary); also safety and adverse events

Publication criteria: published 2010 or later in peer reviewed journals

Exclusion criteria 2.2.2

Studies only available in abstract form, e.g. conference presentations

Grey literature and non-English language material

Studies involving healthy volunteers or experimentally induced pain

Studies on pain due to malignancy or infection, or on acute resolving pain

Studies on interventions not meeting accepted definitions of thermal RFN, e.g. “pulsed” RFN5


Only studies meeting the selection criteria were included in the critical appraisal. Sources identified as relevant but not meeting the criteria are discussed in section 3.4. Excluded studies are listed in the Appendix (section 7.2).

2.3 Evidence grading

For the 2005 IPM guidance, the evidence appraisal was carried out by external research providers. They adapted

evidence grading methods used by the by the New Zealand Guidelines Group – see the IPM website for details.

This review however follows the ACC Evidence Based Healthcare team’s standard approach for evidence based

reviews carried out in house.

Studies meeting the inclusion criteria were assessed for internal validity using the Scottish Intercollegiate Guideline

Network (SIGN) checklist for SRs and meta-analyses. Each study was graded for overall methodological quality

using the SIGN levels of evidence model.

Table 2: SIGN levels of evidence

1++ High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias

1+ Well conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias

1- Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias

2++ High quality systematic reviews of case-control or cohort studies.

High quality case-control or cohort studies with a very low risk of confounding, bias, or chance and a high probability that the relationship is causal

2+ Well conducted case control or cohort studies with a low risk of confounding, bias, or chance and a moderate probability that the relationship is causal

2- Case control or cohort studies with a high risk of confounding, bias, or chance and a significant risk that the relationship is not causal

3 Non-analytic studies, e.g. case reports, case series

4 Expert opinion

SIGN checklists and accompanying materials are available from the SIGN website, www.sign.ac.uk/

3 Findings 3.1 Studies identified

The literature search identified 10 SRs, or guidelines explicitly based on SRs, which met our criteria for inclusion in

the critical appraisal. Four other clinical practice guidelines were also identified.

Table 3: identified RFN studies

Systematic reviews and/or meta-analyses

Guidelines based on a systematic review

Other guidelines

RFN cervical medial branch 26 7 18

RFN lumbar medial branch 59-13 214 15

Studies covering both 22 16 117 118


Some of the SRs were based entirely on higher quality primary research such as RCTs while others also included

lower quality observational studies. The SRs are cross-referenced with the primary studies they cover in the

Appendix (see sections 7.3 and 7.4). A search was carried out to identify any additional RCTs not covered by the

included SRs, but none were found.

SRs and guidelines explicitly based on SRs were included in the critical appraisal. They are summarised below and

analysed in greater detail in the evidence tables (see Appendix sections 7.5 and 7.6). Other guidelines are briefly

discussed in section 3.4. Their recommendations and reasons for exclusion from the critical appraisal are

described in the Appendix (sections 7.7 and 7.2).

3.2 Critical appraisal: effectiveness

Cervical RFN 3.2.1

Four SRs2 6 7 16 and one SR-based guideline17 on cervical RFN were included in the critical appraisal. All five based

their conclusions largely on a single study, namely the 1996 RCT by Lord et al19. They also drew on a range of

observational studies (see Appendix, section 7.3). Three SRs came from an associated group of authors6 16 17.

The 2015 SR by Manchikanti et al16 synthesised the best available evidence on facet joint interventions for chronic

spinal pain. Lower quality studies were excluded and observational studies were only included if fewer than five

RCTs were available. Evidence on cervical RFN was drawn from one RCT and three observational studies. The

SR concluded that the evidence for long term pain relief following cervical RFN was “Level II” (i.e. “based on one

high quality RCT or multiple lower quality RCTs”). This was a well conducted SR, graded SIGN level 1+.

The 2013 SR-based guideline by Manchikanti et al17 updated a previous (2009) version of the American Society of

Interventional Pain Physicians (ASIPP) guideline on interventions for chronic spinal pain. Evidence on cervical RFN

was provided by one RCT and five observational studies. The SR concluded that there was “Fair” evidence for

cervical RFN (i.e. “evidence is sufficient to determine effects on health outcomes, but its strength is limited by the

number, size, quality or consistency of included studies; at least one higher quality RCT with sufficient sample size”). This was a well conducted SR, graded SIGN level 1+. On the basis of this SR, the updated ASIPP guideline

recommended that RFN be used in the management of chronic neck pain following appropriate diagnosis with

controlled diagnostic blocks.

The 2012 SR by Falco et al6 was carried out to inform the ASIPP guideline outlined above. It included the same

studies and reached the same conclusion (i.e. “Fair” evidence) on cervical RFN. The SR noted that the evidence

appeared to be strongest when patients were selected using controlled local anaesthetic blocks with ≥ 80% pain

relief as the entry standard. This was a well conducted SR, graded SIGN level 1+.

The 2012 SR by Smuck et al2 examined the duration of pain relief following initial and repeated RFN facet joint

procedures. It included one RCT and eight observational studies on cervical RFN; five of these reported data on

repeat procedures. This SR found that the average duration of >50% pain relief following initial cervical RFN was

7.3 – 8.6 months. Repeat procedures were successful 67 - 95% of the time where they followed a successful first

procedure. However, success fell to 0 – 67% of the time where the first procedure was not successful. Pain relief

following successful repeat procedures lasted 6 – 12.7 months. The SR therefore concluded that pain relief after

initial cervical RFN generally ends after 7 – 9 months and that repeat RFN is likely to provide additional pain relief

for a similar duration where the initial procedure was successful. The authors noted that the results were similar for

lumbar RFN, but the methodological quality of the cervical studies was better. This SR was judged to have a high

risk of bias and was graded SIGN level 1-. Shortcomings included a fairly limited literature search and lack of detail

on how the quality of individual studies was assessed.

The 2010 SR by Teasell et al7 examined the evidence on surgical and injection-based interventions for chronic

whiplash. Evidence on cervical RFN was provided by one RCT and seven observational studies. Due to the

limitations of the evidence base, this SR was unable to draw firm conclusions about any of the interventions it

examined. However, of all the interventions, RFN appeared to be supported by the strongest evidence. The SR

concluded there was moderate evidence for the effectiveness of cervical RFN as a treatment for chronic whiplash-

related pain. As with the SR by Smuck et al2 outlined above, Teasell noted that pain relief is not permanent and


that the procedure may be repeated with a similar probability of success. This well conducted SR was graded SIGN

level 1+. The UK Centre for Reviews and Dissemination20 (CRD) has assessed this SR and concluded that “the

authors’ cautious conclusions reflected the limited evidence presented and are probably reliable”.

Lumbar RFN 3.2.2

Seven SRs2 9-13 16 and one SR-based guideline17 on lumbar RFN were included in the critical appraisal. Compared

to cervical RFN, they had a larger number of RCTs on which to base their conclusions; some also drew on a range

of observational studies (see Appendix, section 7.4). Four SRs came from an associated group of authors9 12 16 17.

The 2015 SR by Manchikanti et al16 synthesised the best available evidence on facet joint interventions for chronic

spinal pain. Lower quality studies were excluded and observational studies were only included if fewer than five

RCTs were available. Evidence on lumbar RFN was therefore taken from nine RCTs alone. The SR scored the

RCTs moderate to high quality, but could not perform meta-analysis due to clinical and methodological

heterogeneity. All but one of the RCTs reported some degree of effectiveness in terms of short and/or long term

pain relief. The SR therefore concluded that the evidence for long term improvement (pain relief) following lumbar

RFN was “Level II” (i.e. “based on one high quality RCT or multiple lower quality RCTs”). It also noted that results

appeared superior in patients who received RFN after undergoing controlled diagnostic nerve blocks. This was a

well conducted SR, graded SIGN level 1+.

The 2014 SR by Leggett et al11 reviewed sham-controlled RCTs of RFN for chronic low back pain, whether

discogenic, sacroiliac joint or facet joint related. Evidence for lumbar facet joint RFN came from six RCTs. The SR

reported that five of the six had comparable methods, reported statistically significant results and were rated

moderate to high quality. The SR therefore concluded that “This number of similar, high-quality sham-controlled

RCTs on lumbar facet joints provides a robust evidence base that suggests that continuous, conventional RFN is efficacious in reducing lumbar facet joint pain”, at least in the short term (up to one year). However, the authors

noted that reductions in pain scores tended to be modest, their clinical significance (e.g. in terms of functional

improvement or return to work) was not explored and the potential for long term pain relief was unclear. This was a

reasonably well conducted SR, graded SIGN level 1+.

The 2014 SR by Poetscher et al13 reviewed RCTs and quasi-RCTs on the benefits and harms of lumbar RFN for

chronic low back pain. It drew on nine RCTs, seven of which were included in meta-analyses of: (i) RFN versus

placebo (five studies), or (ii) RFN versus steroid injections (two studies). The SR reported that most of the included

RCTs favoured RFN with regard to pain reduction, but rated the quality of the RCTs as low to moderate. The SR

concluded that, up to one year: (i) RFN was more effective than placebo for pain control and functional

improvement, and (ii) RFN was more effective than steroid injections for pain control. It notes however that the

overall quality of the evidence is low and should be interpreted with caution. This was a reasonably well conducted

SR, graded SIGN level 1+. However, the results of the included RCTs could have been reported more clearly and

Australian reviewers have identified flaws in the conduct of the meta-analyses21 22.

The 2013 SR-based guideline by Manchikanti et al17 updated a previous (2009) version of the American Society of

Interventional Pain Physicians (ASIPP) guideline on interventions for chronic spinal pain. Evidence on lumbar RFN

was provided by seven RCTs and 11 observational studies. The RCTs were judged to be of moderate to high

quality and all but one reported positive results for RFN. Likewise, 10 of the 11 observational studies also reported

positive results. The SR concluded that there was “Good” evidence for lumbar RFN for short and long term pain

relief. “Good” evidence was defined as follows: “evidence includes consistent results from well-designed, well-

conducted studies in representative populations that directly assess effects on health outcomes (at least 2

consistent, higher-quality RCTs or studies of diagnostic test accuracy”). This was a well conducted SR, graded

SIGN level 1+. On the basis of this SR, the updated ASIPP guideline recommended that RFN be used in the

management of chronic low back pain following appropriate diagnosis with controlled diagnostic blocks.

The 2012 SR by Falco et al9 was carried out to inform the ASIPP guideline outlined above. It included the same

RCTs and eight of the same observational studies (the guideline included a further three more recently published

studies). Meta-analysis of the RCTs was not possible due to heterogeneity. The findings and conclusions were

similar to those of the guideline, i.e. “Good” evidence for short and long term pain relief and functional improvement

with lumbar RFN. Overall this was a well conducted SR, graded SIGN level 1+. However, CRD reviewers have


cautioned that the reliability of its conclusions may be limited due to the relatively low numbers of participants in

clinically different studies of lumbar RFN that could not be statistically combined23.

The 2012 SR by Smuck et al2 examined the duration of pain relief following initial and repeated RFN facet joint

procedures. It included one RCT and seven observational studies on lumbar RFN; only two studies reported data

on repeat procedures. The SR found that the average duration of >50% pain relief following initial lumbar RFN was

9.0 months. Repeat procedures were successful 33 - 85% of the time where they followed a successful first

procedure. Pain relief following repeat procedures lasted an average 11.6 months. The SR therefore concluded

that pain relief after initial lumbar RFN generally ends after 7 – 9 months and that repeat RFN is likely to provide

additional pain relief for a similar duration where the initial procedure is successful. The findings were similar for

cervical and lumbar RFN, but the methodological quality of the lumbar studies was poorer. This SR was judged to

have a high risk of bias and was graded SIGN level 1-. Shortcomings included a fairly limited literature search and

lack of detail on how the quality of individual studies was assessed.

The 2010 SR by Henschke et al10 reviewed RCT evidence on injection and denervation procedures for chronic low

back pain. It included six RCTs on lumbar RFN. Five of the RCTs had similar selection criteria and sufficient data to

allow pooled analysis. The SR and meta-analyses concluded that there is only low to very low quality evidence to

support the use of lumbar RFN over placebo in patients with chronic low back pain; however, in carefully selected

patients, RFN procedures may be of benefit. This was a well conducted SR, graded SIGN level 1+.

The 2010 SR by Manchikanti et al12 re-appraised the evidence review24 25 on which the 2009 American Pain

Society (APS) guideline26 on interventional therapies for low back pain was based. The 2009 review had found the

RCT evidence on lumbar RFN “difficult to interpret” due to inconsistent results and variations in both the RFN

techniques and the nerve block procedures used to select patients. The APS guideline therefore concluded that the

RCT evidence available at the time was insufficient to reliably evaluate the benefits of lumbar RFN. However, the

Manchikanti SR re-appraised the evidence following the same methodology and found the evidence on lumbar

RFN to be “Fair” (i.e. “sufficient to determine effects on health outcomes, but its strength is limited by the number,

size, quality or consistency of included studies; at least one higher quality RCT with sufficient sample size”). The

evidence on lumbar RFN came from six RCTs. Manchikanti et al concluded that the APS guideline utilised some

studies inappropriately and had methodological flaws. This SR appeared to be well conducted and was graded

SIGN level 1+. The APS guideline and 2009 evidence review did not meet our criteria for inclusion in the critical

appraisal (published prior to 2010), so we did not compare the two reviews.

3.3 Critical appraisal: safety

SRs of both cervical and lumbar RFN reported that complications are rare, but can be serious6 9. One SR of lumbar

RFN noted that it appears to be a safe treatment with most reported complications being infrequent and transitory;

however, the authors felt that more evidence is needed on safety13.

3.4 Information from other guidelines & sources not meeting the criteria for critical appraisal

Cervical RFN 3.4.1

Other clinical practice guidelines

The 2011 American College of Occupational and Environmental Medicine (ACOEM) guideline on cervical and

thoracic disorders did not make a recommendation on RFN for chronic cervical pain; the guideline panel reached a

consensus that the evidence was insufficient to recommend for or against routinely providing RFN8. This guideline

was not included in the critical appraisal as the full version is only available to subscribers.

The 2010 joint American Society of Anesthesiologists (ASA) and American Society of Regional Anesthesia and

Pain Medicine (ASRAPM) guideline on chronic pain management recommended that RFN may be performed for

neck pain, provided that other treatments have been tried first18. The recommendation was supported by evidence

from the RCT by Lord et al19 and by expert opinion. This guideline was not included in the critical appraisal as it

provided insufficient information about development methods.


New Zealand primary study

A 2012 prospective case series by MacVicar et al reported on 104 chronic neck pain patients treated with cervical

RFN at two clinics in Christchurch27. Treatment was carried out according to the 2004 ISIS practice guidelines1.

Only patients who experienced complete pain relief following controlled diagnostic blocks were included.

Successful outcome was defined as ≥80% pain relief for at least six months plus complete restoration of daily

activities, return to work and no further need for health care. Patients at the two clinics achieved successful

outcomes in 74% and 61% of cases respectively, with pain relief lasting 17 – 20 months from first RFN and a

further 15 months after repeat treatment. Interestingly the clinic with the lower success rate treated a higher

proportion of manual workers and patients with work related injuries. The authors concluded that cervical RFN can

be a highly effective treatment for chronic neck pain when performed in a rigorous manner in carefully selected

patients. They suggested that the failure rate (around 30%) may be related to the limited specificity of cervical

medial branch blocks (around 65%)

This study was covered by three of the SRs included in our critical appraisal6 16 17, but was not itself appraised as it

didn’t meet our criteria. According to the SIGN levels of evidence, it would have been graded “3”. However, it is of

interest due to the rigour with which it was carried out (in terms of patient selection and treatment technique), the

positive outcomes and the fact that many of the participants would have been ACC clients.

Australian NTRI/ISCRR evidence review

In 2014 the Australian National Trauma Research Institute (NTRI) and the Institute for Safety, Compensation and

Recovery Research (ISCRR) released an evidence review of RFN in the management of spinal pain of facet joint

origin21 22. They were asked to carry out the review by the Victorian Transport Accident Commission (TAC) and

Work Safe Victoria. The authors used a two stage systematic review process focusing on studies of higher

apparent methodological quality. They concluded that, based on the small 1996 RCT by Lord et al19, there is

moderate level evidence to support the use of cervical RFN for neck pain.

Lumbar RFN 3.4.2

Other clinical practice guidelines

The 2011 ACOEM guideline on back disorders did not make a recommendation on lumbar RFN; the guideline

panel reached a consensus that the evidence was insufficient to recommend for or against routinely providing

RFN14. This guideline was not included in the critical appraisal as the full version is only available to subscribers.

The 2010 joint ASA/ASRAPM guideline on chronic pain management recommended that RFN may be performed

for low back pain, following appropriate diagnostic blocks and provided that other treatments have been tried first18.

The recommendation was supported by evidence from multiple RCTs, some of which were included in a meta-

analysis. This guideline was not included in the critical appraisal as it provided insufficient information about

development methods.

The 2011 “Toward Optimized Practice” guideline on managing low back pain in primary care recommended that

RFN may be beneficial for carefully selected patients with pain originating from the lumbar facet joints15. The

recommendation was apparently based on systematic reviews, but these were not identified. This guideline was

not included in the critical appraisal as it provided insufficient information about development methods.

New Zealand primary studies

A 2013 prospective case series by MacVicar et al28 reports on 106 patients with chronic pain selected, treated and

assessed according to the same rigorous protocols as described above in the authors’ 2012 study on cervical

RFN27. Patients at two community based clinics achieved successful outcomes in 58% and 53% of cases

respectively, with pain relief lasting around 15 months from first RFN and a further 13 months after repeat

treatment. The authors concluded that lumbar RFN can be a highly effective treatment for chronic back pain when

performed in a rigorous manner in carefully selected patients. They suggested a number of reasons for the lower

success rate than that observed in their neck pain study, including: (i) the inclusion of some patients whose pain

was dramatically, but not completely, relieved by controlled diagnostic lumbar medial branch blocks; (ii) the

confounding effects of other sources of pain in some patients; and (iii) false-positive responses to the controlled

diagnostic block, which might have been mitigated by using placebo-controlled blocks instead.


As with MacVicar’s case series on cervical RFN27 outlined in 3.4.1 above, this study was covered by one of the

SRs17 included in our critical appraisal, but was not appraised in its own right as it did not meet our selection

criteria. However it is of interest due to its rigour and applicability to ACC back pain clients.

Australian NTRI/ISCRR evidence review

This 2014 review21 22 (described above) concluded that the evidence on lumbar RFN was of low quality and that the

studies identified had “serious methodological and technical issues that undermined the internal and external

validity of their results”. The reviewers were therefore unable to draw definitive conclusions on the effectiveness of

lumbar RFN. Despite this finding, TAC will fund lumbar RFN for eligible clients – see section 3.4.3 below.

Overseas insurer policies on funding RFN 3.4.3

We identified policies on funding RFN from several overseas insurers and one Australian accident compensation

agency. Their policies are outlined in the table below.

Table 4: insurer funding of RFN

Insurer Funding criteria

TAC Victoria,

Australia

(2009)

TAC funds RFN for clients with persistent spinal pain resulting from transport accident injuries if

the following criteria are met29:

Client has pain of facet joint origin lasting ≥3 months (pain score ≥5/10 on visual analog scale)

and conservative therapy has failed

RFN is performed by registered medical practitioner with sufficient training covering both

technical expertise & appropriate patient selection

Two positive medial branch blocks have taken place with at least 75% pain relief on

standardized outcome measures

Repeat procedures may be funded where (i) relief lasts ≥4 months and (ii) evidence of significant

pain relief, functional improvement and/or reduction in healthcare use is submitted

Bupa, UK

(2012)

Bupa will fund one set of lumbar or cervical facet joint RFN where the consultant has carefully

considered patient selection and where these criteria are met30:

Conservative treatment has failed

The patient has no psychological distress, e.g. depression or post-traumatic stress disorder

RFN forms part of a comprehensive treatment approach by a multidisciplinary team

There is evidence of ≥80% pain relief for an appropriate time period following medial branch

block or intra-articular facet joint injection

There is ongoing assessment following a trial of RFN to show evidence of a response

Pain is localized and pain severity is ≥4/10 on visual analog scale

Appropriate outcome data (e.g. pain diaries) are kept following intervention

Aetna, US

(2015)

Aetna considers outpatient facet joint RFN medically necessary for members with intractable neck

or back pain with/without sciatica if all the following criteria are met31:

Member has had ≥6 months of severe pain that limits activities of daily living and conservative

treatment have failed

Member has had no prior spinal fusion surgery, no significant narrowing of the vertebral canal

or spinal instability requiring surgery

Neurologic studies are negative or fail to confirm disc herniation

Facet joint injections have been successful in relieving the pain

Repeat procedures: only one treatment per level per side is considered medically necessary in a

6 month period


Cigna, US

(2015)

Cigna covers initial RFN for the treatment of chronic back or neck pain if deemed medically

necessary and all of the following criteria are met32:

Pain is exacerbated by extension and rotation, or is associated with lumbar rigidity

There is severe pain unresponsive to ≥6 months of conservative therapy

Facet joint origin of pain is suspected and medial branch block/injection of facet joint with local

anesthetic results in elimination or marked decrease in intensity of pain

Clinical findings and imaging studies suggest no other obvious cause of the pain

Repeat procedures may be funded after 6 months if ≥50% pain relief, with associated functional

improvement, was achieved for at least 10 weeks following the previous treatment

United

Healthcare,

US (2015)

United Healthcare considers RFN of facet joint nerves proven and medically necessary for chronic

cervical, thoracic or lumbar pain if the following criteria are met33:

Positive response to medial branch block injection at the side & level of proposed ablation

Needle placement is confirmed by fluoroscopic guided imaging

There is ≥50% documented pain reduction for at least 10 weeks

Repeat procedures should not be performed more frequently than every 6 months

4 Discussion 4.1 Nature and quality of the evidence

Cervical RFN 4.1.1

Of the five SRs included in the critical appraisal, four were graded 1+ and one was graded 1-. All five based their

conclusions largely on the 2006 RCT by Lord et al19 and drew on observational studies to varying degrees. On the

whole the SRs rated the Lord RCT as high quality, although some commented on its small sample size (n=24). The

SRs largely agreed that the evidence base for cervical RFN was of “fair”, “moderate” or “Level II” quality. All the

SRs focused on pain rather than functional outcomes.

No further RCTs on cervical RFN have been published since the Lord RCT. A recent SR noted that it “continues to

be the landmark evaluation to show efficacy of radiofrequency neurotomy in the cervical spine”16. The RFN

technique used in the Lord RCT is considered optimal for the cervical spine by some reviewers2.

ACC also based its current recommendation largely on the Lord RCT and judged the quality of the evidence

available at the time (2005) to be “medium”. It therefore appears that the quality of the evidence base for cervical

RFN has not changed significantly since. In terms of duration of pain relief, recent SRs support ACC’s 2005

conclusion that cervical RF is effective for a median period of nine months.

Of the three clinical guidelines identified, two17 18 recommended that cervical RFN may be used for chronic neck

pain following appropriate diagnosis using controlled diagnostic blocks and/or after conservative treatments have

failed. A third guideline8 made no recommendation as the evidence was judged to be insufficient.

In addition, a New Zealand based prospective case series27 provided SIGN level 3 evidence that cervical RFN can

deliver long term pain relief and restoration of function when performed in strict accordance with ISIS guidelines1

with rigorous patient selection criteria (i.e. complete relief of pain following controlled diagnostic medial branch

blocks). It is likely that many of the participants would have been ACC clients. The ISIS-recommended RFN

techniques used in this case series were similar to those described in the Lord RCT19.

Lumbar RFN 4.1.2

Of the eight SRs included in the critical appraisal, seven were graded 1+ and one was graded 1-. The lumbar SRs

based their conclusions on a larger evidence base than the cervical SRs; each SR included between one and nine

of 12 identified RCTs published 1994 – 2013 and some also drew on observational studies.


Conclusions about the quality of evidence for lumbar RFN varied, although all the SRs were positive to at least

some extent. Three SRs judged the evidence to be “good” or “robust”9 11 17 and two described it as “fair” or “level

II”12 16. One SR noted that the quality of evidence was lower than that for cervical RFN2; however, this SR focused

on repeat procedures and only one lumbar RCTs met its inclusion criteria.

Two SRs that performed meta-analysis on suitable RCTs were more cautious in their conclusions. Poetscher et al

reported that RFN may be superior to placebo and steroid injections, but noted that the quality of evidence is low

overall and that the findings should therefore be interpreted with caution13. The methodology of this SR has been

criticised by other reviewers21 22. Henschke et al found only low to very low quality evidence to support RFN over

placebo, but noted that the intervention may benefit carefully selected patients10.

Overall the lumbar SRs focused on pain outcomes. Leggett et al commented that RCT evidence on the clinical

significance of reported reductions in pain (e.g. return to work) is unclear11. The meta-analyses by Poetscher13 and

Henschke10 both suggested that RFN may be more effective than placebo for functional outcomes; however,

Poetscher’s methodology is questionable and Henschke noted that the evidence was of very low quality.

ACC’s 2005 guidance on lumbar RFN found that the evidence available at the time was “conflicting”. The size of

the evidence base supporting lumbar RFN has increased significantly since then in terms of published RCTs.

However, the quality of those RCTs appears to be variable. Some authors have argued that RFN outcomes are

better and the evidence is stronger in the cervical spine than the lumbar spine34. This may reflect the lower

prevalence of facet joint pain in the lumbar region, hence greater difficulty in selecting patients likely to respond.

Of the four clinical guidelines identified, three recommended that lumbar RFN may be used to treat chronic low

back pain following appropriate diagnosis/patient selection with controlled diagnostic blocks and/or after

conservative treatments have failed15 17 18. A fourth guideline made no recommendation as it judged the evidence to

be insufficient14.

In addition, we identified a New Zealand based case series28 by the same authors as the cervical RFN study

described in section 4.1.1 above27. It provided further (SIGN level 3) evidence that lumbar RFN can deliver long

term pain relief and restoration of function when performed to a rigorous protocol with carefully selected patients.

However, the authors reported less impressive results with lumbar RFN than with cervical RFN.

Safety and adverse events 4.1.3

SRs included in the critical appraisal reported that medial branch RFN appears to be a safe treatment. Adverse

events tended to be minor and temporary. However, some reviewers have called for more evidence on safety13.

A recent article on facet joint RFN noted that serious adverse effects are rare, occurring in ≤1% of interventions34. It

reported that risks are higher in the cervical compared to the lumbar spine and the majority of adverse events are

local and transient, such as numbness or pain at the injection site. There is also the possibility of complications

common to all needle procedures in spinal sites, such as infection or dural puncture. In addition, X-ray guidance

during the procedure exposes the patient to radiation.

Importance of diagnostic selection criteria and RFN technique 4.1.4

Some of the SRs included in the critical appraisal6 16 17 commented that evidence for RFN appeared to be strongest

when patients were selected using controlled anaesthetic blocks with ≥80% pain relief as the entry criteria.

The latest (2013) edition of the influential ISIS practice guideline5 recommends that complete (or just short of

complete to allow for residual needle pain) relief of pain following controlled diagnostic blocks of the target medial

branches is the “singular indication” for cervical RFN. Blocks may be controlled by placebo or by a comparative

local anaesthetic. Placebo control is the most rigorous, but comparative blocks give high diagnostic confidence for

facet joint-related neck pain and are recommended for routine practice.

For lumbar RFN, the ISIS guideline notes that lower pain relief thresholds are often used in practice, but it warns

that, due to the lower prevalence of facet joint-related back pain, more false positives may result from using less

stringent pain relief criteria. The guideline notes that the best results have been reported using diagnostic criteria of

(i) ≥80% relief after placebo controlled blocks or (ii) complete relief after comparative blocks.


ACC’s 2005 IPM guidance recommended diagnosis with double blind comparative medial branch blocks as a

prerequisite for RFN treatment of facet joint related cervical or low back pain. Similarly, ACC operational guidance

developed in 2014 notes that placebo controlled blocks are preferable for selecting which claimants might benefit

from RFN, but, as this would require the use of three blocks, “the procedures are usually undertaken twice (i.e. on

two separate occasions), in a blinded fashion, using either a short acting or a long acting local anaesthetic”35 36.

The operational guidance states that a positive block requires complete relief of pain apart from a small degree

(<5/100) of needle pain, i.e. the threshold for RFN should be ≥95% pain relief. This is a more rigorous than TAC

and Bupa, who specify 75% and 80% respectively.

It has been argued that many SRs on medial branch RFN focus on the methodological design of included studies

rather than on rigorous patient selection and procedural technique34. It is noteworthy that some of the primary

studies that have reported the best results have selected their patients carefully and treated them according to

rigorous protocols such as the ISIS practice guidelines1 5 These studies include the RCTs by Lord19 (cervical) and

Nath37 (lumbar) and the observational studies by MacVicar (one cervical27, one lumbar28).

A number of international professional associations recommend that medial branch blocks and subsequent

progression to RFN are carried out in accordance with the ISIS practice guidelines. These include the Australian

and New Zealand College of Anaesthetists and Faculty of Pain Medicine, the British Pain Society and the UK Royal

College of Anaesthetists38. ACC would normally expect the RFN procedures it funds to be carried out in

accordance with the ISIS guidelines39.

4.2 Limitations of this review

This review took a pragmatic approach, selecting only SRs published since 2010 for critical appraisal. It therefore

excluded SRs published between 2005 and 2009 on the assumption that evidence emerging in that period would

be picked up by later reviews. During that time there were disagreements between some practitioner organisations

over how evidence was interpreted in the development of pain management guidelines40. This review does not

discuss those controversies in detail, although one of the included SRs (Manchikanti et al 201012) does present one

side of the argument.

This review did not examine primary studies in detail. Critical appraisal of available RCTs may have been of value

in clarifying the evidence, particularly in the case of lumbar RFN. Several of the SRs originated from an associated

group of authors, so there is a risk that biases in interpretation of the evidence may have been compounded and

carried forward.

Only SRs published in peer reviewed journals were included in the critical appraisal; however, other relevant

secondary research (e.g. the Australian NTRI/ISCRR review21 22) was included in the discussion of the evidence –

see section 3.4.

5 Conclusions

5.1 Evidence statements

Cervical RFN

The evidence base for cervical RFN is moderate. It does not appear to have changed significantly since 2005,

especially with regard to higher quality evidence. The recent secondary studies are still largely based on the same

1996 RCT by Lord et al19 that formed the basis for ACC’s 2005 recommendations.

Lumbar RFN

The evidence base for lumbar RFN is low to moderate overall. It has grown since 2005. The recent secondary

studies contain evidence from at least five new RCTs; however, assessments of their quality vary, as do their

conclusions.


5.2 Implications for practice and purchasing

The evidence suggests that RFN of the cervical or lumbar medial branches may provide pain relief of up to one

year’s duration to clients with persistent neck or low back pain of facet joint origin. Careful patient selection based

on accurate diagnosis appears to be central to the success of these interventions.

5.3 Purchasing recommendations

It is suggested that ACC’s 2005 purchasing recommendations be slightly updated to reflect (i) the somewhat

stronger evidence base for lumbar RFN and (ii) the importance of patient selection:

Cervical RFN

Recommendation SIGN recommendation grading*

ACC should continue to purchase RFN of the cervical medial branch to treat persistent neck pain on a case by case basis if the following criteria are met:

There has been a positive response to double-blind, comparative, diagnostic cervical medial branch blocks

The provider offers specifically trained personnel and collects procedural data that is available to guide ACC in future purchasing decisions

Good practice point:

The technique used for cervical RFN should conform with the current practice guidelines laid down by the International Spine Intervention Society (ISIS)

Conditional recommendation “for”

Lumbar RFN

Recommendation SIGN recommendation grading

ACC should continue to purchase RFN of the lumbar medial branch to treat persistent low back pain on a case by case basis if the following criteria are met:

There has been a positive response to double-blind, comparative, diagnostic lumbar medial branch blocks

The provider offers specifically trained personnel and collects procedural data that is available to guide ACC in future purchasing decisions

Good practice point:

The technique used for lumbar RFN should conform with the current practice guidelines laid down by the International Spine Intervention Society (ISIS)

Conditional recommendation “for”

* ‘Conditional’ recommendations should be made where the intervention will do more good than harm for most patients, but may include caveats e.g. on the quality or size of the evidence base, or patient preferences. Conditional recommendations should include ‘should be considered’ or similar in the wording41


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83. Tome-Bermejo F, Barriga-Martin A, Martin JL, Tome-Bermejo F, Barriga-Martin A, Martin JLR. Identifying patients with chronic low back pain likely to benefit from lumbar facet radiofrequency denervation: a prospective study. J Spinal Disord Tech 2011;24(2):69-75.

84. Tzaan WC, Tasker RR. Percutaneous radiofrequency facet rhizotomy - Experience with 118 procedures and reappraisal of its value. Canadian Journal of Neurological Sciences 2000;27(2):125-30.

85. Yilmaz C, Kabatas S, Cansever T, Gulsen S, Coven I, Caner H, et al. Radiofrequency facet joint neurotomy in treatment of facet syndrome. J Spinal Disord Tech 2010;23(7):480-5.

86. Manchikanti L, Falco FJ, Singh V, Benyamin RM, Racz GB, Helm 2nd S, et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part I: introduction and general considerations. Pain physician 2013;16(2 Suppl):S1-48.

87. Higgins JP, Altman DG, Gotzsche PC, Juni P, Moher D, Oxman AD, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. Bmj 2011;343:d5928.


7 Appendices

7.1 Search Strategy

Medline and Embase databases via the Ovid platform:

1. exp pain/

2. pain$.mp.

3. analg$.mp.

4. exp analgesia/

5. exp analgesics/

6. or/1-5

7. case stud$.pt.

8. case ser$.pt.

9. case series.pt.

10. case series.tw.

11. case series/

12. case series.mp.

13. case stud$.tw.

14. or/7-13

15. randomized controlled trial.pt.

16. controlled clinical trial.pt.

17. randomized controlled trials/

18. random allocation/

19. double-blind method/

20. single-blind method/

21. or/15-20

22. clinical trial.pt.

23. exp clinical trial/

24. (clin$ adj25 trial$).tw.

25. ((singl$ or doubl$ or tripl$ or trebl$) adj25 (blind$

or mask$)).tw.

26. placebos/

27. placebo$.tw.

28. random$.tw.

29. research design/

30. or/22-29

31. (clinical adj3 stud$).mp.

32. (systematic adj3 review$).mp.

33. (meta adj3 analysis).mp.

34. or/31-33

35. treatment outcome/

36. meta-analysis/

37. exp guideline/

38. or/35-37

39. 14 or 21 or 30 or 34 or 38

40. 39 and 6

41. *Catheter Ablation/

42. exp *Denervation/

43. exp rhizotomy/ or Pulsed Radiofrequency

Treatment/

44. ((rf$ or prf or radiofrequency) adj3 (ablat$ or

neuroablat$ or neuroblat$ or neurotomy or

denervat$ or rhizotomy or neurolyis)).mp.

45. prfn.mp.

46. thermal coagulation.mp.

47. (thermal$ adj2 coagulat$).mp.

48. or/41-47

49. exp Zygapophyseal Joint/ or exp Lumbar Vertebrae/

50. Back Pain/ or Chronic Pain/

51. (lumbar adj2 medial).tw.

52. exp Whiplash Injuries/ or exp Neck Pain/ or exp

Cervical Vertebrae/ or exp Median Neuropathy/ or

exp Pain Management/

53. (cervical adj2 medial).tw.

54. ((occipital adj2 nerve$) or (third adj2 occipital) or

"3rd occipital").tw.

55. (spine or spinal or back or neck or lumbar or

cervical or whiplash or headache or occipital).mp.

56. or/49-55

57. 40 and 48 and 56


7.2 Excluded studies

Study Reason for exclusion

American College of

Occupational &

Environmental Medicine

(ACOEM) 20118

US guideline on cervical and thoracic spine disorders. The full version is only

available to subscribers, so we were unable to examine the methodology in detail

or view the included studies. The guideline is therefore not included in the critical

appraisal. A summary of the recommendations and supporting evidence, based on

information available from the national Guideline Clearinghouse, is presented in

section 7.7.

American College of

Occupational &

Environmental Medicine

(ACOEM) 201114

US guideline on low back disorders. The full version is only available to

subscribers, so we were unable to examine the methodology in detail or view the

included studies. The guideline is therefore not included in the critical appraisal.

Discussed briefly in section 3.4 & a summary of the recommendations and

supporting evidence, based on information available from the national Guideline

Clearinghouse, is presented in section 7.8.

American Society of

Anesthesiologists/

American Society of

Regional Anesthesia &

Pain Medicine 201018

US guideline on chronic pain management. Insufficient information was available

on aspects of the systematic review & meta-analyses, namely the literature search

and the methods (if any) used to evaluate the quality of individual studies. The

guideline is therefore not included in the critical appraisal. Discussed briefly in

section 3.4 & summaries of the recommendations & supporting evidence are

presented in sections 7.7 and 7.8.

Chou 201042 Subscription to Clinical Evidence required in order to access full review.

Clavisi 201421 22 Evidence review & technical report commissioned by Australian work & road

accident compensation agencies. Counts as “grey” (i.e. not formally published)

literature, hence excluded from critical appraisal. Discussed briefly in section 3.4.

Fritzler 201143 Narrative synthesis of RCTs. Quality of RCTs not assessed.

MacVicar et al 201227 Case series on cervical RFN in New Zealand; discussed in section 3.4.

MacVicar et al 201328 Case series on lumbar RFN in New Zealand; discussed in section 3.4.

Toward Optimized

Practice 201115

Canadian guideline on managing low back pain in primary care. We were unable

to obtain the full systematic review on which the guideline was based. This

guideline is therefore not included in the critical appraisal. A summary of the

recommendations and supporting evidence is presented in section 7.8.

Van Kleef 201044 Narrative review.

Veizi 201445 Narrative review.

7.3 Systematic reviews & guidelines – what studies do they cover? Cervical

Manchikanti

et al 201516

Manchikanti

et al 201317

Falco et al

20126

Smuck et al

20122

Teasell et al

20107 46

Randomised controlled trials (RCTs)

Lord 199619 ● ● ● ● ●

Observational studies

Barnsley 200547 ●

Cohen 200748 ● ●

Govind 200349 ● ●

Husted 200850 ● ●

Lee 200751 ●

Liliang et al 200852 ●

Lord 199553 ● ●

MacVicar 201227 ● ● ●

McDonald 199954 ● ●

Prushansky et al 200655 ●

Royal 200256 ●

Sapir 200157 ● ● ● ● ●

Shin 200658 ●

Speldewinde 201159 ● ● ●

Wallis et al 199760 ●


7.4 Systematic reviews & guidelines – what studies do they cover? Lumbar

Man

chikan

ti

et al 20151

6

Leg

gett et al

2014

11

Po

etscher et

al 20141

3

Man

chikan

ti

et al 20131

7

Falco

et al

2012 9

Sm

uck et al

2012

2

Hen

schk

e et

al 20101

0

Man

chikan

ti

et al 20101

2

Randomised controlled trials (RCTs)

Civelek 201261 ● ● ● ●

Cohen 201062 ● ● ●

Dobrogowski 200563 ● ● ● ●

Duger 201264 ●

Gallagher 199465 ● ● ● ●

Lakemeier 201366 ● ●

Leclaire 200167 ● ● ● ●

Moon 201368 ●

Nath 200837 ● ● ● ● ● ● ●

Tekin 200769 ● ● ● ● ● ● ●

Van Kleef 199970 ● ● ● ● ● ● ●

Van Wijk 200571 ● ● ● ● ● ● ●

Observational studies

Cohen 201372 ●

Derby 201273 ●

Dreyfuss 200074 ●

Gofeld 200775 ● ● ●

MacVicar 201328 ●

Martinez-Suarez 200576 ● ●

Masala 201277 ● ●

North 199478 ●

Ogsbury 197779 ●

Park 200680 ●

Royal 200256 ●

Schofferman 200481 ●

Son 201082 ● ●

Speldewinde 201159 ● ●

Tome-Bermejo 201183 ● ●

Tzaan 200084 ● ●

Yilmaz 201085 ● ●

7.5 Systematic reviews (SRs) & SR-based guidelines – evidence tables: cervical

Study Methodology Outcomes & results Paper grading1 ACC reviewer

comments &

evidence level

Reference:

Manchikantietal201516

Studydesign:

SR&“bestevidencesynthesis”oncervical,thoracic&lumbarfacetjointinterventions

Researchquestion:

Whatistheeffectivenessoffacetjointinterventionsinthemanagementofchronicspinalpain?

Funding:

Nodetailsgiven

Numberofstudies:

EvidenceoncervicalRFNwasprovidedby1RCTand3observationalstudies

Literaturesearch:

Comprehensive:PubMed,CochraneLibrary,NationalGuidelineClearinghouse(NGC)&clinicaltrials.govsearched1966–March2015;previousSRs&crossreferenceswerealsochecked

Inclusioncriteria:

RCTs&observationalstudiesoffacetjointinterventionsincludingcervicalRFNforchronic(≥3months)neckpain

Exclusioncriteria:

Fullydescribed;lowqualitystudieswereexcluded;observationalstudieswereonlyconsideredif≤5RCTsavailablepermodality/site

Characteristicsofincludedstudies:

RCTn=24;observationalstudiesn=50,104and130,284participantsintotal

ReviewersscoredtheRCT(Lord199619)highlyforqualitybutnotedstudysizewassmall&thestatisticalanalysishasbeencriticised;theobservationalstudieswerealsoratedhighquality

TheRCTsuggestedeffectivepainreliefintheshort&longterm;theobservationalstudiessuggestedeffectivelongtermpainrelief

SRconclusion:

Forlong‐termimprovementinthecervicalspine,thereisLevelIIevidenceforRFN

LevelIIevidence=“evidenceobtainedfromatleastonerelevanthighqualityRCTormultiplerelevantmoderateorlowqualityRCTs”

Clearlydefinedresearchquestion Y Reasonablywellconductedsystematicreview,SIGNlevel1+

However,itsconclusionsoncervicalRFNarelimitedbythelackofhighqualitystudies

Twopeopleselectedstudies&extracteddata

Y

Comprehensiveliteraturesearchcarriedout

Y

Authorsclearlystatehowtheylimitedreviewbypublicationtype

Y

Included&excludedstudieslisted N2

Characteristicsofincludedstudiesprovided

Y

Scientificqualityofincludedstudiesassessed&documented

Y

Scientificqualityofincludedstudiesassessedappropriately

Y

Appropriatemethodsusedtocombineindividualstudyfindings

NA

Likelihoodofpublicationbiasassessed

NA

Conflictsofinterestdeclared Y

AreresultsofSRdirectlyapplicabletoACCIPMclients?

Y

1 Y = yes, N = no, NA = not applicable, ? = can’t say (information is missing or unclear) 2 The reviewers only listed excluded RCTs; excluded observational studies were not listed and reasons for exclusion (presumably quality-related) were not given



comments &

evidence level

Reference:


Studydesign:

SRofeligiblestudiescarriedouttoupdatetheAmericanSocietyofInterventionalPainPhysicians(ASIPP)2009guidelinerecommendations

Researchquestion:

Whatisthequalityofevidenceforinterventionaltechniquesusedtodiagnose&treatchronicspinalpain?

Funding:

ASIPP;noexternalfunding

Numberofstudies:

EvidenceoncervicalRFNprovidedby1RCTand5observationalstudies

Literaturesearch:

Comprehensive:PubMed,Embase,CochraneLibrary,NationalGuidelineClearinghouse(NGC),clinicaltrials.gov,previousSRs&crossreferences(describedinintroductionpaper86)

Inclusioncriteria:

RCTs,observational&diagnosticstudiesonpatientsaged18andoverwithspinalpain(i)ofatleast3monthsdurationand(ii)forwhomconservativemanagementhasfailed;alsocasereportsforadverseevents

Exclusioncriteria:

Describedinintroductionpaper86


RCTn=24,observationalstudiesn=46ton=130,total421participants

TheRCTwasfoundtobewellconductedthoughthesamplesizewassmall;RFNshowedpositiveresultsforpainreliefinshort&longterm(upto12months)

Mostoftheobservationalstudiesalsodemonstratedpositiveshort&longtermresults

SRconclusion:

TheevidenceforconventionalcervicalRFNisfair

Guidelinerecommendation:

ConventionalRFNcanberecommendedinthemanagementofchronicneckpainfollowingappropriatediagnosisusingcontrolleddiagnosticblocks

Clearlydefinedresearchquestion Y Awellconductedsystematicreview,SIGNlevel1+

However,itsconclusionsoncervicalRFNarelimitedbythelackofhighqualityliterature(onlyoneofthe6includedstudieswasanRCT)


Y


Y


Y

Included&excludedstudieslisted Y


Y


Y


Y


NA


N



Y

3 Y = yes, N = no, NA = not applicable, ? = can’t say (information is missing or unclear)



comments &

evidence level

Reference:

Falcoetal20126

Studydesign:

SRcarriedouttoinform2013guidelineupdatebyManchikantietal17(seeabove)

Researchquestion:

Whatisthequalityofevidencefortherapeuticcervicalfacetjointinterventionsforchronicneckpain?

Funding:

Noexternalfunding

Numberofstudies:

1RCTand5observationalstudies

Literaturesearch:

Comprehensive:PubMed,Embase,CochraneLibrary,NationalGuidelineClearinghouse(NGC),clinicaltrials.gov,previousSRs&crossreferences

Inclusioncriteria:

RCTs&observationalstudiesonpatientsaged18andoverwithchronicneckpain(i)ofatleast3monthsdurationand(ii)forwhomconservativemanagementhasfailed;alsocasereportsforadverseevents

Exclusioncriteria:

Described


RCTn=24,observationalstudiesn=46ton=130,total421participants

MainfindingsdescribedinManchikantietal17(seeabove)

Complicationsarerare,butcanbeserious

Evidenceappearstobestrongestwhenpatientsareselectedusingcontrolledlocalanaestheticblockswith≥80%painreliefastheentrystandard

TheRCT19achievedahigh(11/12)Cochranequalityscore

Theobservationalstudieswereallscoredmoderatequality(7/12)

Allstudiesscoredhighly(4/5or5/5)forclinicalrelevance

SRconclusions:

TheevidenceforconventionalcervicalRFNisfair


However,itsconclusionsarelimitedbythelackofhighqualityliterature(onlyoneofthe6includedstudieswasanRCT)


Y


Y


Y



Y


Y


Y


NA


N



Y




comments &

evidence level

Reference:

Smucketal20122

Studydesign:

SRofRCTsandobservationalstudies

Researchquestion:

Whatisthedurationofpainrelieffollowinginitial&repeatedRFNforcervical&lumbarzygapo‐physialjointpain?

Funding:

Nodetailsgiven

Numberofstudies:

EvidenceoncervicalRFNprovidedby1RCTand8observationalstudies

Literaturesearch:

PubMedonly

Inclusioncriteria:

StudiesoncontinuousRFNofthemedialbranchnervestotreatcervicalpain

Exclusioncriteria:

Studieswereexcludediftheydidnotdescribe,inquantifiableform,boththeduration&amountofpainrelieffollowingRFN


RCTn=12(RFNarmonly??);observationalstudiesn=19ton=63,total259participants

InitialRFN:averagedurationof>50%painreliefwas7.3–8.6months

RepeatRFN:5ofthecervicalstudiesreporteddataonrepeatRFNprocedures

Repeatproceduresweresuccessful67‐95%ofthetimewhen1stprocedurewassuccessful,0–67%ofthetimewhen1stprocedurewasunsuccessful

AveragedurationofsuccessfulrepeatRFNwas6–12.7months

Overall,themethodologicalqualityofcervicalstudiesexceededthatoflumbarstudies

SRconclusions:

PainreliefafterinitialRFNgenerallyendsafter7–9months.RepeatRFNislikelytoprovideadditionalpainreliefforasimilardurationifinitialRFNwassuccessful.Resultsaresimilarforcervical&lumbarstudies

Clearlydefinedresearchquestion Y Systematicreviewwithhighriskofbias,SIGNlevel1‐

Noinformationonhowstudyqualitywasassessed

Only1cervicalstudywasanRCT

Severalhighqualitystudies(including3lumbarRCTs)wereexcludedfornotreportingamountordurationofpainreliefinquantifiableform

IncontrastwithotherSRs&ACC’sownsearch,thisSRcapturedmorecervicalthanlumbarstudies;thismayhavebeendueinparttotheinclusioncriteria&limitedliteraturesearch


?


N


Y



Y


?


?


NA


N



Y




comments &

evidence level

Reference:

Teaselletal2010746

Studydesign:

SRofsurgical&injection‐basedinterventionsforchronicwhiplash‐associateddisorder(WAD)

Researchquestion:

HoweffectivearetheaboveinterventionsinitiatedduringthechronicphaseofWAD?

Funding:

Notstated

Numberofstudies:

CervicalfacetjointRFN:1RCTandsevenobservationalstudies

Literaturesearch:

Comprehensive:Medline,CINAHL,Embase,PsycINFO,CochraneLibrary,WebofScience

Inclusioncriteria:

PrimaryclinicalstudiesofeligibleinterventionsforWADof>12weeksduration;minimumstudysample=3adultparticipantswithWAD

Exclusioncriteria:

Described


OneRCT(n=24,Lordetal199619)plusarelatedfollowupstudy54(n=28)&subgroupanalysis60(n=17);alsofiveunrelatedobservationalstudies(n=14ton=46,141participantsintotal)

TheRCTbyLordetalwasfoundtobeofgoodmethodologicalquality(PEDroscore=8/10)

Theobservationalstudieswerenotqualityassessed&conclusionsforRFNwerebasedlargelyontheRCT

SRconclusions:

DuetothelimitationsoftheevidencebaseitwasnotpossibletodrawfirmconclusionsontheeffectivenessofanyoftheWADinterventionsincludedintheSR

OftheinterventionsevaluatedintheSR,RFNappearedtobesupportedbythestrongestevidence:thereismoderateevidencesupportingtheeffectivenessofcervicalRFNasatreatmentforchronicWAD‐relatedpain

Painreliefisnotpermanent;however,itappearsthattheprocedurecanberepeatedwithsimilarprobabilityofsuccess


OthercommentatorshaveagreedthattheSR’scautiousconclusionsreflectthelimitedevidencepresentedandareprobablyreliable20


?/Y


Y


Y

Included&excludedstudieslisted N


Y


Y


Y


NA


N

Conflictsofinterestdeclared N


Y



7.6 Systematic reviews (SRs) & SR-based guidelines – evidence tables: lumbar


comments &

evidence level

Reference:


Studydesign:

UpdatedSR&“bestevidencesynthesis”oncervical,thoracic&lumbarfacetjointinterventions

Researchquestion:

Whatistheeffectivenessoffacetjointinterventionsinthemanagementofchronicspinalpain?

Funding:

Nodetailsgiven

Numberofstudies:

EvidenceonlumbarRFNwasprovidedby9RCTs

Literaturesearch:

Comprehensive:PubMed,CochraneLibrary,NationalGuidelineClearinghouse(NGC)&clinicaltrials.govsearched1966–March2015;previousSRs&crossreferenceswerealsochecked

Inclusioncriteria:

RCTsoffacetjointinterventionsincludinglumbarRFNforchronic(≥3months)lowbackpain

Exclusioncriteria:

Fullydescribed;lowqualitystudieswereexcluded;observationalstudieswereonlyconsideredif≤5RCTsavailablepermodality/site


RCTsn=31ton=100(580participantsintotal)

ReviewersscoredtheRCTsmoderatetohighquality

Noobservationalstudieswereincludedas≥5RCTswereavailable

Meta‐analysisoftheRCTswasnotperformedduetolackofclinical&methodologicalhomogeneity

OfthenineRCTs,allbutonesuggestedsomedegreeofeffectivenessintermsofshortand/orlongtermpainrelief

Overall,resultsappearsuperiorinpatientswhoreceiveRFNafterundergoingcontrolleddiagnosticblocks

SRconclusion:

Forlong‐termimprovementinthelumbarspine,thereisLevelIIevidenceforRFN

LevelIIevidence=“evidenceobtainedfromatleastonerelevanthighqualityRCTormultiplerelevantmoderateorlowqualityRCTs”

Clearlydefinedresearchquestion Y Reasonablywellconductedsystematicreview,SIGNlevel1+


Y


Y


Y



Y


Y


Y


NA


NA



Y




comments &

evidence level

Reference:

Leggettetal201411

Studydesign:

SRofRCTs

Researchquestion:

WhatistheefficacyofRFNforchroniclowbackpainassociatedwithlumbarfacetjoints,sacroiliacjoints,spinaldiscsorthecoccyx?

Funding:

Noexternalfunding

Numberofstudies:

EvidenceonRFNforlumbarfacetjointpainprovidedby6RCTs(also3RCTsondiscogenicpain&2RCTsonsacroiliacpain)

Literaturesearch:

Comprehensive:Medline,Embase,PubMed,SportDiscus,CINAHL,CochraneLibrary&CRDdatabases

Inclusioncriteria:

ShamcontrolledRCTsinvolvingpatientswithlowbackpainof≥3monthsduration(shamRFN=identicalneedleplacementbutnocurrentapplied)

Exclusioncriteria:

Described


FacetjointRCTsrangedfromn=31ton=81(303participantsintotal)

5ofthe6facetjointRCTswereratedasmoderatetohighqualityusingCochraneriskofbiastool87

TheremainingRCTwasratedashavinghighriskofselectivereportingbias67

5ofthe6RCTshadcomparablemethods&foundstatisticallysignificantresultswithRFN

However:

Followuptimeswererelativelyshort(2monthsto1year)

Reductionsinpainscoresweremodestandtheirclinicalsignificancewasnotexplored

SRconclusions:

ThisnumberofhighqualityRCTsusingsimilarmethodssuggeststhatcontinuousconventionalRFNisefficaciousinreducinglumbarfacetjointpainintheshortterm;however,theclinicalsignificanceofthereliefobtained(e.g.returntowork)&thepotentialforlongtermpainreliefareunclear

Clearlydefinedresearchquestion Y ReasonablywellconductedsystematicreviewofRCTs,SIGNlevel1+

Limitationsinclude:

(i)Narrativesynthesisonly:meta‐analysisnotcarriedoutduetolackofmeandifferencereportingintheprimarystudies

(ii)QualityofRCTsmaybeoverrated–comparewithPoetscheretal(2014)13below


Y


Y


Y



Y


Y


Y


NA


N



Y




comments &

evidence level

Reference:

Poetscheretal201413

Studydesign:

SRandmeta‐analysisofRCTs

Researchquestion:

Whatarethetreatmenteffects(benefitsandharms)ofRFNforpatientswithfacetjoint‐relatedchroniclowbackpain?

Funding:

Noexternalfunding

Numberofstudies:

9RCTs;7ofthemwereincludedinmeta‐analysesofRFNvs.placebo&RFNvs.steroidinjections

Literaturesearch:

Comprehensive:Medline,Embase,LILACS,Central

Inclusioncriteria:

RCTs&quasi‐RCTscomparingRFNtonerveblocks,anaesthetic/steroidinjectionsorplacebo(e.g.shamRFN)inthetreatmentofpatientswithfacetjoint‐relatedchroniclowbackpain

Exclusioncriteria:

Studiesinvolvingpatientswithradicularpain&previousfailedlumbarRFN


RCTsrangedfromn=31ton=120(618participantsintotal)

OverallthequalityofincludedRCTswasratedlowtomoderate;mostofthestudieshadmethodological,proceduralorreportingweaknesses,particularlyselectivereportingbias

MoststudiesfavouredRFNwithregardtopainreduction

Meta‐analysissuggestedpainreliefbenefitsmaypersistupto1yearpostintervention

PooledanalysisofRFNvs.placeboforpainreduction(5studies)favouredRFN:meandifference‐2.15,95%CI‐1.71to‐2.59

ResultsforfunctionalimprovementfavouredRFNoverplacebo

PooledanalysisofRFNvs.steroidinjectionforpainreduction(2studies)favouredRFN:meandifference‐1.76,95%CI‐1.34to‐2.18

Therewasinsufficientevidenceoncomplications&noneoncosteffectiveness

SRconclusions:

Thereisevidencethat:(i)RFNis

Clearlydefinedresearchquestion Y Reasonablywellconductedsystematicreview&meta‐analysisofRCTs,SIGNlevel1+

However,thisSRhasbeencriticisedbyNTRI/ISCRRreviewers2122dueto:

(i) InadequatereportingontheresultsofincludedRCTs

(ii) Inadequateinformationontheirrisksofbias

(iii) Inadequatediscussionoflinksbetweenqualityandresults

(iv) Flawedmeta‐analysismethodology


Y

Comprehensiveliterature searchcarriedout

Y


Y



Y


Y


Y


?


N

Conflictsofinterestdeclared ?


Y



moreeffectivethanplaceboforpaincontrol&functionalimprovement(upto1year);and(ii)RFNismoreeffectivethansteroidinjectionsforpaincontrol(upto1year)

RFNappearstobeasafetreatment

OverallthequalityofRCTsoflumbarRFNislowandtheevidencereviewedhereshouldbeinterpretedwithcaution



comments &

evidence level

Reference:


Studydesign:

SRofeligiblestudiescarriedouttoupdatetheAmericanSocietyofInterventionalPainPhysicians(ASIPP)2009guidelinerecommendations

Researchquestion:

Whatisthequalityofevidenceforinterventionaltechniquesusedtodiagnose&treatchronicspinalpain?

Funding:

ASIPP;noexternalfunding

Numberofstudies:

EvidenceonlumbarRFNcamefrom7RCTs&11observationalstudies

Literaturesearch:

Comprehensive:PubMed,Embase,CochraneLibrary,NationalGuidelineClearinghouse(NGC),clinicaltrials.gov,previousSRs&crossreferences(describedinintroductionpaper86)

Inclusioncriteria:

RCTs,observational&diagnosticstudiesonpatientsaged18andoverwithspinalpain(i)ofatleast3monthsdurationand(ii)forwhomconservativemanagementhasfailed;alsocasereportsforadverseevents

Exclusioncriteria:

Describedinintroductionpaper86


RCTsrangedfromn=31ton=100(total442participants);observ‐ationalstudiesrangedfromn=51ton=252(total1146participants)

Ofthe7RCTs,6reportedpositiveresults

TheRCTswereallofmoderatetohighmethodologicalquality

Ofthe11observationalstudies10reportedpositiveresultsand1reportedindeterminateresults

SRconclusions:

TheevidenceforconventionallumbarRFNisgoodforshort‐andlong‐termpainrelief

TheevidenceforpulsedlumbarRFNislimited(basedononeRCT69andoneobservationalstudy77thatmettheSRinclusioncriteria)

Guidelinerecommendation:

Inthemanagementofchroniclowbackpainoffacetjointorigin,conventionalRFNcanberecommendedfollowingappropriatediagnosisusingcontrolleddiagnosticblocks



Y


Y


Y



Y


Y


Y


NA


N



Y




comments &

evidence level

Reference:

Falcoetal20129

Studydesign:

SRcarriedouttoinform2013guidelineupdatebyManchikantietal17(seeabove)

Researchquestion:

Whatisthequalityofevidencefortherapeuticlumbarfacetjointinterventionsinmanagingchroniclowbackpain?

Funding:

Noexternalfunding

Numberofstudies:

7RCTsand8observationalstudies(Manchikantietal,seeabove,included3additional,morerecentobservationalstudies)

Literaturesearch:

Comprehensive:PubMed,Embase,CochraneLibrary,NationalGuidelineClearinghouse(NGC),clinicaltrials.gov,previousSRs&crossreferences

Inclusioncriteria:

RCTs&observationalstudiesonpatientsaged≥18withchroniclumbarfacetjointpain(i)ofatleast3monthsdurationand(ii)forwhomconservativemanagementhasfailed;alsocasereportsforadverseevents

Exclusioncriteria:

Described


RCTsrangedfromn=31ton=100(total442participants);observ‐ationalstudiesrangedfromn=51ton=252(total934participants)

FindingsforRCTsdescribedinManchikantietal17(seeabove)

Ofthe8observationalstudies,7reportedpositiveresults&1reportedindeterminateresults

7oftheobservationalstudieswereratedmoderatequalityandone76wasratedlowquality

Complicationsarerare,butcanbeserious

Meta‐analysiswasnotpossibleduetoheterogeneity

SRconclusions:

EvidencefortheuseofconventionallumbarRFNisgoodforshort&longtermpainrelief&functionalimprovement

EvidenceforpulsedRFNislimited

Clearlydefinedresearchquestion Y Overallawellconductedsystematicreview,SIGNlevel1+

However,othercommentatorshavearguedthatthereliabilityoftheconclusionsmaybeaffectedbytherelativelylownumbersofparticipantsinindividual,clinicallydifferentstudiesthatwerenotstatisticallycombined23


Y


Y


Y



Y


Y


Y


NA

Likelihoodofpublication biasassessed

N



Y




comments &

evidence level

Reference:

Smucketal20122

Studydesign:

SRofRCTsandobservationalstudies

Researchquestion:

Whatisthedurationofpainrelieffollowinginitial&repeatedRFNforcervical&lumbarzygapo‐physialjointpain?

Funding:

Nodetailsgiven

Numberofstudies:

EvidenceonlumbarRFNprovidedby1RCT&7observationalstudies

Literaturesearch:

PubMedonly

Inclusioncriteria:

StudiesoncontinuousRFNofthemedialbranchnervestotreatlowbackpain

Exclusioncriteria:

Studieswereexcludediftheydidnotdescribe,inquantifiableform,boththeduration&amountofpainrelieffollowingRFN


RCTn=45;observationalstudiesn=9ton=174,total451participants

InitialRFN:averagedurationof>50%painreliefwas9,0months

RepeatRFN:only2ofthelumbarstudiesreporteddataonrepeatRFNprocedures

Repeatproceduresweresuccessful33‐85%ofthetimewhen1stprocedurewassuccessful

AveragedurationofsuccessfulrepeatRFNwas11.6months

Overall,themethodologicalqualityoflumbarstudieswaspoorerthanthatofcervicalstudies

SRconclusions:

PainreliefafterinitialRFNgenerallyendsafter7–9months.RepeatRFNislikelytoprovideadditionalpainreliefforasimilardurationifinitialRFNwassuccessful.Resultsaresimilarforcervical&lumbarstudies

Clearlydefinedresearchquestion Y Systematicreviewwithhighriskofbias,SIGNlevel1‐

Noinformationonhowstudyqualitywasassessed

Only1lumbarstudywasanRCT

Severalhighqualitystudies(including3lumbarRCTs)wereexcludedfornotreportingamountordurationofpainreliefinquantifiableform

IncontrastwithotherSRs&ACC’sownsearch,thisSRcapturedmorecervicalthanlumbarstudies;thismayhavebeendueinparttotheselectioncriteria&limitedliteraturesearch


?


N


Y



Y


?


?


NA


N



Y




comments &

evidence level

Reference:

Henschkeetal201010

Studydesign:

SRandmeta‐analysisofRCTs

Researchquestion:

Whatistheevidencefortheeffectivenessofinjectiontherapies&denervationproceduresforchroniclowbackpain?

Funding:

Nodetailsgiven

Numberofstudies:

EvidenceonlumbarRFNwasprovidedby6RCTs

Literaturesearch:

TheauthorsscreenedexistingSRs,searchedtheCochraneBackReviewGrouptrialregister&reference‐checkedthestudiestheyidentified

Inclusioncriteria:

RCTsofinjection&denervationprocedurestoanyspinalsiteinadultswithchronic(>12weeksduration)lowbackpain

Exclusioncriteria:

Described


6RCTscomparingRFNofthelumbarmedialbranchtoshamprocedure;n=31ton=81(atotalof323participants)

The6RCTsscored6‐10outof11forquality(scores<6suggesthighriskofbias)

5ofthe6RCTshadsimilarselectioncriteria&sufficientdatatoallowpooledanalysis:

PainShortterm<4weeks

Lowqualityevidence(2RCTs,n=90)thatRFNismoreeffectivethanplaceboWMD(weightedmeandifference)‐18.1595%CI‐24.21to‐12.09

Inter‐mediate1‐6months

Lowqualityevidence(2RCTs,n=112)thatRFNisnomoreeffectivethanplaceboWMD‐9.2995%CI‐22.57to4.00

Longterm>6months

Lowqualityevidence(3RCTs,n=130)thatRFNisnomoreeffectivethanplaceboWMD‐6.9995%CI‐14.73to0.76

FunctionalstatusShortterm<4weeks

Verylowqualityevidence(1RCT,n=60)thatRFNismoreeffectivethanplaceboWMD‐5.5395%CI‐8.66to‐2.40

Conventionalvs.pulsedRFNLongterm>6months

Thereisverylowqualityevidence(1RCT,n=40)thatconventionalRFNismoreeffectivethanpulsedRFNforpain&functionaloutcomes

SRconclusions:

Inpatientswithchroniclowbackpain,thereisonlylowtoverylowqualityevidencetosupporttheuseofdenervationproceduresoverplacebo;however,itcannotberuledoutthatincarefullyselectedpatients,somedenervationproceduresmaybeofbenefit

Clearlydefinedresearchquestion

Y Awellconductedsystematicreview,SIGNlevel1+


Y/?


?


Y

Included&excludedstudieslisted

Y


Y


Y


Y


Y


Y

Conflictsofinterestdeclared N


Y




comments &

evidence level

Reference:


Studydesign:

SR;re‐appraisalof2009evidencereview24forAmericanPainSociety(APS)guidelineontherapeuticinterventionsforlowbackpain26

Researchquestion:

Howeffectiveareinjection&otherinterventionaltherapiesfornon‐radicular/radicularlowbackpain&spinalstenosis,andunderwhatcircumstances?

Funding:

Noexternalfunding

SRfollowedsamemethodologyas2009evidencereview

Numberofstudies:

LumbarfacetjointRFN:6RCTs

Literaturesearch:

Comprehensive:PubMed,Embase,CochraneLibrary&cross‐referencing

Inclusioncriteria:

SRs&RCTsofinterventionaltherapiesforchroniclowbackpain

Exclusioncriteria:

Described


RCTsrangedfromn=31ton=81(323participantsintotal)

The2009reviewfoundtheevidenceonlumbarfacetjointRFN“difficulttointerpret”duetovaryingRFNtechniques&useofdifferentdiagnosticnerveblockprocedurestoselectpatients;itconcludedthattheevidencewasonthewholepoor

Re‐appraisingthesameevidence&usingthesamecriteria,thisSRfoundtheevidenceforlumbarfacetjointRFNtobefair(i.e.atleastonehigherqualityRCT37withsufficientsamplesize)

SRconclusions:

TheevidenceforlumbarfacetjointRFNisfair

Thisre‐appraisalfindsevidencesimilartotheAPSguidelinesforseveralprocedures,butdiffersextensivelyfromtheAPSguidelinesformultipleotherproceduresincludinglumbarRFN

Theauthorsconcludethattheirre‐appraisalshowstheAPSguidelinesutilisedsomestudiesinappropriately&have“significantmethodologicfailures”whichraiseconcernsabout“transparency,accountability,consistency,andindependence”



Y


Y


Y



Y


Y


Y


NA


?



Y



7.7 Other clinical practice guidelines – summary table: cervical

Guideline Recommendation Evidence for recommendation

American College of Occupational &

Environmental Medicine (ACOEM)

(2011)8. Cervical & thoracic spine

disorders guideline

For patients with chronic cervico-thoracic pain

confirmed with diagnostic blocks, but who do not have

radiculopathy and who have failed conservative

treatment, no recommendation on radiofrequency

neurotomy or facet rhizotomy could be made.

Radiofrequency neurotomy is not recommended for

cervicogenic headache.

Grade I (consensus based): the evidence was

insufficient to recommend for or against routinely

providing the intervention. Evidence of effectiveness

was lacking, of poor quality or conflicting. The

Evidence-Based Practice Panel (EBPP) therefore made

no recommendation

Grade B: moderately not recommended. The

intervention should not be routinely provided to eligible

patients. The EBPP found at least intermediate

evidence that the intervention is ineffective, or that

harms or costs outweigh benefits

American Society of

Anaesthesiologists/American Society

of Regional Anesthesia & Pain

Medicine (2010)18. Practice guidelines

for chronic pain management

Conventional (e.g. 80°C) radiofrequency ablation may

be performed for neck pain

Other treatment modalities should be attempted before

ablative techniques are considered

The recommendation was supported (i) by category A3

evidence, i.e. a single RCT (Lord et al 199619); and (ii)

by expert and membership opinion


7.8 Other clinical practice guidelines – summary table: lumbar

Guideline Recommendation Evidence for recommendation

American College of Occupational &

Environmental Medicine (ACOEM)

(2011)14. Low back disorders

guideline

Radiofrequency neurotomy or facet rhizotomy is not

recommended for acute/sub-acute low back pain,

radicular pain syndromes or spinal stenosis

For patients with chronic low back pain confirmed with

diagnostic blocks, but who do not have radiculopathy

and who have failed conservative treatment, no

recommendation could be made

Grade C: it was recommended against routinely

providing the intervention. The EBPP found at least

intermediate evidence that harms and costs exceed

benefits based on limited evidence.

Grade I (consensus based): the evidence was

insufficient to recommend for or against routinely

providing the intervention. Evidence of effectiveness

was lacking, of poor quality or conflicting. The EBPP

therefore made no recommendation.

Toward Optimized Practice (2011)15.

Guideline for the evidence-informed

primary care management of low

back pain 2nd edition (Canada)

Medial branch neurotomy may be beneficial for carefully

selected patients with a clinical diagnosis of pain

originating from the lumbar facet joints; studies

demonstrate pain relief lasting longer than 3 months

The recommendation was based on systematic reviews,

but these were not identified.

American Society of

Anaesthesiologists/American Society

of Regional Anesthesia & Pain

Medicine (2010)18. Practice guidelines

for chronic pain management

Conventional (e.g. 80°C) or thermal (e.g. 67°C)

radiofrequency ablation of the medial branch nerves to

the facet joint should be performed for low back pain

when previous diagnostic or therapeutic injections of the

joint or medial branch nerves have provided temporary

relief

Other treatment modalities should be attempted before

ablative techniques are considered

The recommendation is based on (i) category A1

evidence, i.e. multiple RCTs with aggregated findings

supported by meta-analysis (the ASA methodology

group’s meta-analysis of 5 RCTs of RF ablation vs.

sham controls found a pain relief effect size of -0.30);

and (ii) expert & membership opinion

Radiofrequency neurotomy of the cervical & lumbar medial … · 2019-03-27 · ACC Research:...

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