Comparison of the effectiveness of six and twoacupuncture point regimens in osteoarthritis of theknee: a randomised trial

Wirat Taechaarpornkul,1 Daranee Suvapan,1 Chaniya Theppanom,1

Chantima Chanthipwaree,1 Aroon Chirawatkul2

1 Sirindhorn National MedicalRehabilitation Center,Nonthaburi, Thailand; 2 Facultyof Public Health, Khon KaenUniversity, Thailand

Correspondence to:Wirat Taechaarpornkul,Sirindhorn National MedicalRehabilitation Center, 88/26 SoiBamrasnaradura, Tiwanon Road,Nonthaburi 11000, Thailand;wiratt@health.moph.go.th

ABSTRACTBackground: Although substantial data have supportedthe effectiveness of acupuncture for treating kneeosteoarthritis (OA), the number of points used has varied.The objective of this study was to compare theeffectiveness of six and two acupuncture points in thetreatment of knee OA.Methods: A randomised trial of knee OA patients wasconducted. Patients were randomly allocated into twogroups of 35. The ‘‘six point group’’ received treatment atsix acupuncture points, ST35, EX-LE4 (Neixiyan), ST36,SP9, SP10 and ST34, while the ‘‘two point group’’received treatment at just the first pair of points, ST35and EX-LE4. Both groups received twice weekly electro-acupuncture on 10 occasions. Electrical stimulation wascarried out at low-frequency of 3 Hz to all points, with theintensity as high as tolerable. Both groups were allowedto take a 200 mg celecoxib capsule per day for intolerablepain. Patients were assessed at baseline, week 5, week 9and week 13, using a Thai language version of theWestern Ontario and McMaster Osteoarthritis Index(WOMAC). Global assessment of change after 10treatments was also recorded.Results: Acupuncture at both six and two acupuncturepoints was associated with significant improvement.Mean total WOMAC score at weeks 5 and 13 of patientsin both groups showed no significant difference statisti-cally (p = 0.75 and p = 0.51). Moreover, the number ofcelecoxib capsules taken, global assessment of globalchange and body weight change of both groups alsoshowed no statistical difference.Conclusion: This evidence suggests that electroacu-puncture to two local points may be sufficient to treatknee OA, but in view of some limitations to this studyfurther research is necessary before this can be statedconclusively.

An epidemiological study has shown that kneeosteoarthritis (OA) affects about 35 percent of theThai population aged over 60 years living in urbanarea of Bangkok.1 In general, the treatment of kneeOA in Thailand has followed the guidelines of theAmerican College of Rheumatology, classified intothree groups: nonpharmacological modalities,pharmacological therapy and surgical treatment.2

One of the nonpharmacological modalities isacupuncture which was recommended as a levelB treatment by the European League againstRheumatism in 2003.3 Moreover, several articles,research reports and systemic reviews havereported the effectiveness and safety of acupunc-ture for knee OA treatment.4–18 The number of

knee OA patients mainly treated by acupunctureat Sirindhorn National Medical RehabilitationCentre (SNMRC) has been increasing each year.

The number of acupuncture points used fortreatment of knee OA has varied between studies.Using a greater number of points is likely toproduce more discomfort, uses more needles and ismore time consuming than using fewer points.Therefore, it would be valuable to know whetherthe use of fewer points is as effective as the use of ahigher number of points. The lowest number ofpoints that has been reported as effective is thetwo points per knee, ST35 and EX-LE4, used by Nget al.19 Another study of 146 general knee painpatients, including knee OA, in China showed 96%total improvement rate from pricking at ST35 andEX-LE4 points.20 However, no study so far hascompared the effectiveness of different numbers ofacupuncture points for knee OA. This was theobjective of the study reported here.

METHODWe conducted a randomised, comparative trial.The study protocol was approved by the ethicscommittee of SNMRC. We selected patients withsymptomatic knee OA in the outpatient section ofSNMRC according to the eligibility criteria sum-marised in box 1.

Sample sizeThe sample size for testing the difference betweenmeans was calculated with the Epical 2000programme, by setting the standard deviation ofthe Western Ontario and McMaster OsteoarthritisIndex (WOMAC) score of 17.967 and meandifference of total WOMAC score between groupsof 15, power of 0.9 and a level of significance at0.05. A sample size of 30 patients per group plus anestimated 5 dropouts would be needed.

InterventionsThe patients were randomly allocated into twogroups. Treatment allocation was carried out byblock randomisation (block size two) using opaquesealed envelopes. We stratified by the mainconfounding factors, body mass index and baselinetotal WOMAC score, to ensure balance betweengroups.

The ‘‘six point group’’ received treatment at sixacupuncture points: EX-LE4, ST35, ST36, SP9,SP10 and ST34.This choice of acupuncture pointwas based on the Traditional Chinese Medicine

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(TCM) theory for treating Bi syndrome, using local points onchannels that traverse the area of pain.23 The ‘‘two point group’’received treatment at only two of these points: EX-LE4 andST35.

To avoid contamination, the two groups were scheduled toreceive acupuncture treatment at different times. The depth ofneedling was 18–25 mm for EX-LE4 and ST35, 15–25 mm forSP9 and ST34 and 15–30 mm for ST36 and SP10. Both groupsreceived acupuncture twice weekly from baseline to week 5, atotal of 10 treatments. The skin was sterilised with 70%alcohol. Sterile disposable 30 gauge, 40 mm stainless steelacupuncture needles with guide tubes were used in allprocedures. The needles were stimulated manually to elicitde qi, verified by the patients. Electrical stimulation wasapplied for 30 minutes with biphasic pulse continuous of3 Hz, to the needles in the following pairs: EX-LE4 and ST35;ST36 and SP9; and SP10 and ST34. The stimulation intensitywas as high as tolerable below the pain threshold, and wasadjusted continuously according to the patient’s response. Theacupuncture treatment was applied only to the knee that waspainful.

Both groups were advised to do quadriceps exercise 30 timesper day during the study period. Patients in both groups wereallowed to take one 200 mg celecoxib capsule per day whenintolerable pain occurred and the number of capsules taken wasrecorded by the patients.3 Both groups of patients wererequested not to receive other treatments including any physicaltherapies, any pain-killing medicines and acupuncture treat-ment from another place.

Acupuncture treatment of both groups were carried out bythe same medical doctor, a specialist in acupuncture accreditedby the President of Shanghai University of Traditional ChineseMedicine, with more than nine years of clinical experience inacupuncture.

Outcome measuresThe modified Thai version of WOMAC osteoarthritis indexfor knee OA was used as the primary outcome, comprisingnumerical rating scales for the three dimensions, pain (0–50),stiffness (0–20) and physical function (0–150).24 The assess-ment was carried out by a well-trained nurse blinded to groupallocation at 0, 5, 9 and 13 weeks. Secondary outcomes werethe number of celecoxib capsules taken by the end of13 weeks, and self assessment of global change after theacupuncture treatment, using a questionnaire with sevenlevels: much better, better, slightly better, no change, slightlyworse, worse, worst.

Statistical analysisBetween-group analysis of WOMAC score was performed usingan unpaired t test and the 95% confidence interval of thedifference between groups. If WOMAC scores did not havenormal frequency distribution, the data would be modifiedbefore testing; but if not normal after transformation, we usedthe nonparametric Wilcoxon Rank Sum test. To check whetherthe data had normal distribution frequency, we used ShapiroWilk or W test. For the intention to treat analysis, the lastavailable score was carried forward.

Figure 1 Study flowchart.

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RESULTSRecruitment took place between February and August 2007.From a total of 320 knee OA patients, 216 were excluded byexclusion criteria and 34 did not meet the inclusion criteria. Theremaining 70 patients were included and randomly allocatedinto two groups of 35 patients, the two point group and the sixpoint group.

During the first five weeks of acupuncture treatment, fourpatients dropped out of the study. Three were in the six pointgroup: one for personal reasons; one because of back pain; onebecause of knee inflammation following over-activity afteracupuncture. One patient in the two point group dropped outbecause of knee injury caused by a motorcycle accident. TheWOMAC score at baseline was carried forward to all timepoints (weeks 5, 9 and 13), making the assumption of no changefor non-completers. All patients receiving the full course oftreatment attended for follow up at weeks 9 and 13.

Baseline characteristics of both groups are presented in table 1.Mean total WOMAC score at baseline of both groups showedno significant difference (p = 0.68). Reductions in mean totalWOMAC score at weeks 5 and 13 compared to baseline wereobserved, and were highly significant (p,0.001 for all compar-isons.) At both time points, there was no significant differencebetween the groups (p = 0.75 and p = 0.51) as shown in table 2.Also, there was no difference between group at 9 weeks, datanot presented. Figure 2 shows that the mean total WOMACscore of both groups reduced sharply at the fifth week thenremained fairly constant to the end of week 13.

Self assessment scores of change compared with beforeacupuncture were compared using exact test. No patients ineither group chose slightly worse, worse or worst. There was nodifference between the groups (p = 0.579) as shown in table 3.The number of celecoxib capsules used during the first fiveweeks and over the whole study period (13 weeks) of bothgroups showed no significant difference (p = 0.68 and p = 0.52)as shown in table 4. The body weight and the body weightchange from baseline at week 5 and week 13 of both groupsshowed no significant difference (data not shown; p.0.05). Sideeffects were found in both groups. The total number of adverseevents in 10 treatments in the six and two group were,respectively, contusion 11/8; dull pain 10/8; other 1/0. Nopatient withdrew because of any side effects.

DISCUSSIONIn this study, the effectiveness of the two points and the sixpoints acupuncture in knee OA, as assessed by the mean totalWOMAC score at week 5 and week 13, showed no significant

difference. We did not include a control group receiving noacupuncture treatment since several previous studies havealready shown the effectiveness of acupuncture in the treat-ment of knee OA.7–16

According to our literature review on acupuncture for kneeOA, there were several studies using four points,16 six points,11

nine points,7 8 10 and more than nine points per knee.9 Based onthis review, we selected six frequently used points, all ofwhich are indicated for treatment of knee pain because theyare placed on channels that traverse the knee joints. Amongthe six points, ST35 and EX-LE4 were the only two pointslocated directly at the knee joint, the other four points beingrelatively distant.

In one reference textbook,25 ST35 is described as a commonpoint for treating pain of the knee joints, and EX-LE4 is usedfor treating of both knee pain and knee arthritis. Moreover,ST35 is common to several clinical trials as a major point fortreating knee-related disorder.8 14 16 26 Berman et al performednine point acupuncture for treating knee OA, but appliedelectrical stimulation only at EX-LE4 as it was regardedtheoretically as the most important point.8 This evidence allsuggests that ST35 and EX-LE4 are the two major points fortreatment of knee OA. We regarded the other points we usedas supporting points.

Figure 2 Mean total WOMAC score (ITT, intention to treat analysis) ateach time point.

Box 1 Eligibility criteria

Inclusion criteria1. Clinical criteria for the classification of knee OA followedAmerican College of Rheumatology using classification treeincluding21:

– 1.1 Knee pain and age >40 years and– 1.2 Morning stiffness (30 minutes in duration and– 1.3 Crepitus on motion

2. Documented radiographic change of OA (Kellgren-Lawrence,22

grade >2)3. Patients agree to sign consent form.

Exclusion criteria1. History of bleeding disorder or currently use of anticoagulants2. Knee inflammation or knee contracture3. History of knee surgery4. Intra-articular corticosteroid or hyaluronate injection in the kneeduring the past six months5. Pregnancy or breast feeding6. Previous experience with acupuncture due to knee OA duringthe past 12 months7. Previous attending physical therapy program or other treatmentfor knee OA (with the exception of nonsteroidal anti-inflammatorydrugs) during the past four weeks8. Serious uncontrolled concomitant illness (eg, coronary arterydiseases)9. Diseases causing referred pain to the knee, eg, Myofascial painsyndrome (MPS), disc herniation10. Currently receiving antineoplastic or immunosuppressivedrugs.11. Unable to do activity of daily living and unable to follow theprogram12. Obesity with body mass index >32 kg/m2

13. Contraindication to medication with celecoxib14. History of severe gastric-duodenal ulcer.15. History of taking chondroprotective agents, eg, glucosaminesulphate.

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One limitation of the study is that it was powered to show adifference between groups, and not for equivalence. To showthat two and six point treatments were truly equivalent, wewould probably require a much larger number of patients.However, the confidence intervals for the two groups in fig 2overlap to a considerable extent, suggesting that any differencebetween the treatments is small and possibly not clinicallysignificant.

Another potential limitation is that the effect of homeexercises may have concealed any effect of acupuncture.

However, from the results of a recent systematic review, wedo not believe it likely that quadriceps exercises alone wouldhave produced a fall as great as 70 points in the WOMAC scoreover eight weeks.27

We must consider whether the effect can be explained bydifferential usage of analgesic drugs. There was a trend towardsgreater use of drugs in the two point group, whose meannumber of the capsules at week 13 was greater (6.0 capsules)than in the six point group (4.5 capsules). However, thedifference was not statistically significant, and the total numberof capsules used over the 13 week period was very low.Therefore, it is unlikely that the difference was due to thegreater use of pain medication in the two point group.Moreover, since the usage of analgesics was relatively low, itseems unlikely to have been sufficient to have concealed anydifference in the effects of the two acupuncture regimens.

It is generally accepted that acupuncture can reduce pain viaat least two mechanisms7: (1) activation of the gate controlsystem28; (2) stimulation of neurochemical release in the centralnervous system.29–31 In addition, it has been reported that usinglow frequency (2–6 Hz) electrical stimulation can induceendorphin release.31 Since we found no statistically significantdifference between our groups, we suggest that the effect ofelectroacupuncture (EA) at these ST35 and EX-LE4 alone, giventwice weekly for 10 treatments, was likely to be an ‘‘adequate’’treatment, at least for our patients in this particular setting, sothat additional treatment to other points added nothing to theeffect. It should be noted that these findings may not apply toacupuncture for chronic knee pain from other conditions, orpain as part of a general systemic condition.

In one review of 13 randomised, controlled trials for knee OA,Vas and White speculated that the optimal result from

Table 1 Baseline characteristics of knee OA patients

Six group Two group

Age, mean (SD), years 61.66 (9.55) 60.74 (9.30)

Age, min–max, years 44–85 40–87

Age 40–60 year n (%) 15 (42.9) 18 (51.4)

Age.60 year n (%) 20 (57.1) 17 (48.6)

Sex n (%)

Male 6 (17.1%) 5 (14.3%)

Female 29 (82.9%) 30 (85.7%)

Duration of knee pain n (%)

,5 year 25 (71.4%) 24 (68.6%)

5–10 year 9 (25.7%) 6 (17.1%)

.10 year 1 (2.9%) 5 (14.3%)

BMI, mean (SD), kg/m2 28.08 (2.72) 26.96 (3.16)

BMI, min–max, kg/m2 21.48–31.46 20.53–31.78

Kellgren grade n (%)

Grade 2 18 (51.4%) 18 (51.4%)

Grade 3 13 (37.1%) 16 (45.7%)

Grade 4 4 (11.4%) 1 (2.9%)

Target knee n (%)

Both knees 28 (80.0%) 29 (82.9%)

Left knee 3 (8.6%) 2 (5.7%)

Right knee 4 (11.4%) 4 (11.4%)

WOMAC score at baseline

WOMAC total mean (SD) 140.74 (32.90) 137.57 (31.18)

WOMAC pain mean (SD) 32.46 (8.23) 31.00 (7.57)

WOMAC stiffness mean (SD) 12.00 (4.10) 11.94 (3.89)

WOMAC function mean (SD) 96.29 (23.43) 94.63 (22.17)

BMI, body mass index; ITT, intention to treat; WOMAC, Western Ontario andMcMaster Osteoarthritis Index.

Table 2 Comparison of WOMAC scores at baseline, end of treatment (week 5) and follow up (week 13), together with between group statistical test,and differences

Baseline Week 5 Week 13

Mean SD t Test* Mean SD t Test*Difference(95% CI) Mean SD t Test*

Difference(95% CI)

Totals

Six group 140.7 32.9 0.68 67 42.2 0.75 3 (221.6, 15.7) 61.6 45 0.51 7.6 (230.5,15.4)

Two group 137.6 31.2 70 35.6 69.2 51.1

Pain

Six group 32.5 8.2 0.44 14.7 10.1 0.74 0.8 (23.7, 5.2) 12.9 10 0.24 3.2 (22.1,8.4)

Two group 31 7.6 15.5 8.6 16.1 12

Stiffness

Six group 12 4.1 0.95 5.6 4.6 0.42 0.8 (21.2, 2.8) 5.5 4.6 0.36 1.1 (21.2,3.3)

Two group 11.9 3.9 6.4 3.5 6.6 4.8

Function

Six group 96.3 23.4 0.76 46.7 29.2 0.83 1.4 (11.5, 14.3) 43.2 31.6 0.1 13.3 (22.7,29.4)

Two group 94.6 22.2 48.1 24.6 56.5 35.5

*t Test of group differences at time period, using independent t test. All data are intention to treat. Both groups n = 35. WOMAC, Western Ontario and McMaster OsteoarthritisIndex.

Table 3 Self assessment of change in the groups after 10 acupuncturetreatments

Muchbetter Better

Slightlybetter

Nochange Total

Exact pvalue

Sixgroup

17 (53.1%) 10 (31.3%) 4 (12.5%) 1 (3.1%) 32 (100%) 0.579

Twogroup

16 (47.1%) 13 (38.2%) 2 (5.9%) 3 (8.8%) 34 (100%)

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acupuncture treatment may involve: high temperature climate,high expectation of patients; minimum of four needles; EArather than manual acupuncture; strong electrical stimulation;and a course of at least 10 treatments.15 Our study wasperformed in Thailand where the climate is tropical, and weused EA with strong electrical stimulation for 10 treatments.However, we have found that two needles per knee areadequate for treatment to be effective.

A study in knee OA comparing treatment in three groups(n = 8) receiving EA at ST35 and EX-LE4, transcutaneouselectrical nerve stimulation (TENS) and a control groupreceiving only knee care education concluded that both EAand TENS treatment were effective in reducing knee pain, andEA treatment gave better improvement in function thanTENS.19 Our study using the same two points EA showed theeffectiveness in knee OA treatment.

Previous studies have observed that the effectiveness ofacupuncture treatment in knee OA lasted for at least one monthafter the end of treatment.8 9 In our study, the mean totalWOMAC score of both groups reduced greatly at week 5 after10 treatments, as compared to baseline, and remained fairlyconstant at that low level for at least eight weeks (fig 2). Thiscarry-over effect has also been reported in treatment bydiacerein, one of the symptomatic slow acting drugs for OA(sysadoa).32 However, we could not absolutely be certain thatthis was solely due to the effect of acupuncture or partlybecause of the quadriceps exercise that the patients of bothgroups did for 30 times per day.

CONCLUSIONWe found no difference between the effectiveness of EA intreating knee OA using two points at ST35 and EX-LE4 alone,and six points, viz ST35 and EX-LE4 together with ST36, SP9,SP10 and ST34. Although there are possible limitations, theresults suggest that EA given to two local points on the knee,twice weekly for 10 weeks, could be an adequate treatment forthis type of condition. Since this question relates to theefficiency of acupuncture practice, further research to addressit is recommended. The point EX-LE4 lies directly over the jointspace of the knee and therefore should be used with greatcaution to avoid the risk of joint space infection.

Acknowledgements: We thank Attasit Srisubat, Cheng Zicheng, ManatPongchaidecha, Prapun Phongkhanittanon, Punnee Pitisuttithum, SanguansakThanaviratananich, Somkiat Potisat, Sompon Thassaniyom, Somkiat Asawapooreekornand Vilai Kuptniratsaikul.

Funding: This study was granted by the Academic Supporting Fund of MedicalServices Department.

Competing interests: None.

REFERENCES1. Kuptniratsaikul V, Tosayanonda O, Nilganuwong S, et al. The epidemiology of

osteoarthritis of the knee in elderly patients living an urban area of Bangkok. J MedAssoc Thai 2002;85:154–61.

2. American College of Rheumatology subcommittee on osteoarthritis guidelines.Recommendations for the medical management of osteoarthritis of the hip and knee.Arthritis Rheum 2000;43:1905–15.

3. Jordan KM, Arden NK, Doherty M, et al. EULAR Recommendations 2003 : anevidence based approach to the management of knee osteoarthritis: Report of a TaskForce of the Standing Committee for International Clinical Studies IncludingTherapeutic Trials (ESCISIT). Ann Rheum Dis 2003;62:1145–55.

4. White A, Kawakita K. The evidence on acupuncture for knee osteoarthritis—editorial summary on the implications for health policy. Acupunct Med2006;24(Suppl):S71–76.

5. NCCAM Press Office. Acupuncture relieves pain and improves function in kneeosteoarthritis. NIH NewS 20 Dec 2004. National Institutes of Health http://nccam.nih.gov/news/2004/acu-osteo/pressrelease.htm (accessed 6 Feb 2009).

6. Liu T, Liu C. Acupuncture for treating osteoarthritis of the knee and the hip. ArthritisRheum 2006;54:3375–77.

7. Berman BM, Singh BB, Lao L, et al. A randomized trial of acupuncture as anadjunctive therapy in osteoarthritis of the knee. Rheumatology (Oxford)1999;38:346–54.

8. Berman BM, Lao L, Langenberg P, et al. Effectiveness of acupuncture as adjunctivetherapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med2004;141:901–10.

9. Witt C, Brinkhaus B, Jena S, et al. Acupuncture in patients with osteoarthritis of theknee: a randomised trial. Lancet 2005;366:136–43.

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11. Christensen BV, Iuhl IU, Vilbek H, et al. Acupuncture treatment of severe kneeosteoarthrosis. A long-term study. Acta Anaesthesiol Scand 1992;36:519–25.

12. Vas J, Perea-Milla E, Mendez C. Acupuncture and moxibustion as an adjunctivetreatment for osteoarthritis of the knee—a large case series. Acupunct Med2004;22:23–28.

13. Vas J, Mendez C, Perea-Milla E. Acupuncture vs Streiberger needle in kneeosteoarthritis: an RCT. Acupunct Med 2006;24(Suppl):S15–24.

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Table 4 Mean celecoxib capsule usage during treatment period (weeks1 to 5) and whole study period (weeks 1 to 13)

NMean(capsule) SD p Value

Difference(95% CI)

1–5 weeks

Six group 32 1.53 2.33 0.68 20.24 (20.91 to 1.39)

Two group 34 1.29 2.34

1–13 weeks

Six group 32 4.53 7.87 0.52 +1.47 (23.07 to 6.01)

Two group 34 6.00 10.47

Summary points

c Trials have shown that acupuncture is an effective treatmentfor knee osteoarthritis

c However, it is not known what id the optimal number of pointsto treat

c In this RCT, we found no difference betweenelectroacupuncture given at two compared with six points

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osteoarthritis of the knee: a randomised trialtwo acupuncture point regimens in Comparison of the effectiveness of six and

Chantima Chanthipwaree and Aroon ChirawatkulWirat Taechaarpornkul, Daranee Suvapan, Chaniya Theppanom,

doi: 10.1136/aim.2008.0000672009 27: 3-8 Acupunct Med 

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