Analgesic Ladder in TBI Analgesic Ladder in TBI Pain ManagementPain Management

Jim Plunkett, M.D.Jim Plunkett, M.D.

VA Medical Center/UC Dept of VA Medical Center/UC Dept of PM&RPM&R

2013 NKY TBI Conference2013 NKY TBI Conference

March 22, 2013March 22, 2013

Chronic PainChronic Pain

IASP definitionIASP definition ““an unpleasant sensory or emotional an unpleasant sensory or emotional

response to a stimulus associated with actual response to a stimulus associated with actual or potential tissue damage”or potential tissue damage”

Pain “lasting longer than the anticipated Pain “lasting longer than the anticipated course of recovery” – often 3-6 monthscourse of recovery” – often 3-6 months

Neurologic, physiologic, and emotional Neurologic, physiologic, and emotional components ( suffering) components ( suffering)

Nociceptive PainNociceptive Pain

Noxious stimuli activating peripheral Noxious stimuli activating peripheral receptors producing typical acute pain receptors producing typical acute pain along a-delta and C fibersalong a-delta and C fibers

Pin-prick or stab wound or stubbed toePin-prick or stab wound or stubbed toe Burn injuryBurn injury FracturesFractures

Neuropathic PainNeuropathic Pain

Pain associated with injury or disease of Pain associated with injury or disease of peripheral nervesperipheral nerves DM peripheral neuropathyDM peripheral neuropathy Shingles ( PHN)Shingles ( PHN) RadiculopathyRadiculopathy

Burning, shooting, lancinating painBurning, shooting, lancinating pain

Allodynia, hyperpathia, central sensitizationAllodynia, hyperpathia, central sensitization

Beginning to End: The Chronic Pain CycleBeginning to End: The Chronic Pain Cycle Pathology:-Muscle atrophy, weakness;-Bone loss;-Immunocomprimise-Depression / Suicide

Less activeKinesophobiaDecreased motivationIncreased isolationRole loss

Disability

Pathophysiology of Maintenance:-Radiculopathy-Neuroma traction-Myofascial sensitization-Brain, SC pathology (atrophy, reorganization)

Psychopathologyof maintenance:-Encoded anxiety dysregulation - PTSD-Emotional allodynia-Mood disorder

NeurogenicInflammation:- Glial activation- Pro-inflammatory cytokines- blood-nerve barrier dysruption

Acute injuryand pain

PeripheralSensitization:New Na+ channelscause lower threshold

Central Sensitization-Neuroplastic changes

Gallagher RM, in Ebert & Kerns, 2010)

PTSD N=23268.2% 2.9%

16.5%

42.1%

6.8%

5.3%

10.3%

12.6%

TBI N=22766.8%

Chronic Pain N=27781.5%

Prevalence of Chronic Pain, PTSD and TBI in a sample of 340 OEF/OIF veterans

Lew, Otis, Tun et al., (in Press). Prevalence of Chronic Pain, Posttraumatic Stress Disorder and Post-concussive Symptoms in OEF/OIF Veterans: The Polytrauma Clinical Triad. JRRD

WHO Analgesic Ladder WHO Analgesic Ladder 19861986

Step 1: Non-opioids (tylenol +/- NSAID)Step 1: Non-opioids (tylenol +/- NSAID) +/- adjuvants+/- adjuvants

Step 2: “Weak opioids” Step 2: “Weak opioids” + non-opioids +/- adjuvants+ non-opioids +/- adjuvants

Step 3: “ Strong opioids”Step 3: “ Strong opioids” + non-opioids +/- adjuvants+ non-opioids +/- adjuvants

Expanded Analgesic LadderExpanded Analgesic Ladder Activity modificationActivity modification Thermal modalitiesThermal modalities Electrical topical modalitiesElectrical topical modalities Topical medical analgesicsTopical medical analgesics Gait and mobility aidesGait and mobility aides BracingBracing Stretching/ROM/massageStretching/ROM/massage StrengtheningStrengthening Aerobic reconditioningAerobic reconditioning Basic self-care health habitsBasic self-care health habits

Ladder ( con’t)Ladder ( con’t)

Non-opioidsNon-opioids AcetaminophenAcetaminophen AspirinAspirin

NSAIDSNSAIDS

AdjuvantsAdjuvants

Muscle relaxantsMuscle relaxants Anti-epileptic drugs ( AEDs)Anti-epileptic drugs ( AEDs) Anti-depressantsAnti-depressants CorticosteroidsCorticosteroids

NarcoticsNarcotics

Pseudo-narcotics ( tramadol)Pseudo-narcotics ( tramadol) Weak potency vs. Strong potencyWeak potency vs. Strong potency Short-acting vs. Long- actingShort-acting vs. Long- acting Oral vs. topical vs. transmucosal vs. IVOral vs. topical vs. transmucosal vs. IV Combination Combination

Invasive proceduresInvasive procedures

BasicBasic Myofascial trigger point injectionsMyofascial trigger point injections Intra-articular injectionsIntra-articular injections Botox – headache and spasticityBotox – headache and spasticity AcupunctureAcupuncture Nerve blocksNerve blocks

Invasive proceduresInvasive procedures

Advanced: ( Fluoro-guided)Advanced: ( Fluoro-guided) Cervical, thoracic, and lumbosacral ESICervical, thoracic, and lumbosacral ESI Facet injectionsFacet injections Medial branch blocksMedial branch blocks Sacro-iliac joint injectionsSacro-iliac joint injections RF nerve ablationRF nerve ablation IDETIDET Stellate ganglion and LS sympathetic blocksStellate ganglion and LS sympathetic blocks Celiac plexus block, Bier blockCeliac plexus block, Bier block

Quaternary InterventionsQuaternary Interventions

Spinal Cord ( or Dorsal column) stimulatorSpinal Cord ( or Dorsal column) stimulator Intrathecal Pain pumpIntrathecal Pain pump Rhizotomy or myelotomyRhizotomy or myelotomy Deep Brain stimulationDeep Brain stimulation ThalatomyThalatomy

Cognitive/Behavioral therapiesCognitive/Behavioral therapies

Progressive relaxationProgressive relaxation Guided imageryGuided imagery Individual and Group therapyIndividual and Group therapy Cognitive/behavioral therapyCognitive/behavioral therapy BiofeedbackBiofeedback

Pain CategoriesPain Categories

““Orthopedic”Orthopedic” OA/DJDOA/DJD Muscles, tendons, ligamentsMuscles, tendons, ligaments

““Neuropathic”Neuropathic” Myelopathy, radiculopathyMyelopathy, radiculopathy Peripheral neuropathyPeripheral neuropathy

Complex/Central PainComplex/Central Pain

CategoriesCategories

Above + Chronicity help guide treatmentAbove + Chronicity help guide treatment Other factors – Secondary GainOther factors – Secondary Gain

Workmen’s Comp, Tort claim, SSDIWorkmen’s Comp, Tort claim, SSDI

Medical co-morbiditiesMedical co-morbidities Traumatic Brain InjuryTraumatic Brain Injury

AgeAge

HeadacheHeadache

Episodic Headache•Characterize type•Abortive therapy

•Maximum 6 doses/week

Chronic Daily Headache•> 15 HA days per month•Analgesic rebound•Prophylaxis is key

Abortive

NSAIDs•GI side effects

IbuprofenNaproxen SodiumAspirin

Triptans•Contraindicated in patients with CAD

CombinationMedications•Cognitive side effects•Risk of W/D

FioricetFiorinalMidrin

ProphylaxisOnset of action ~ 4 wks

Beta-blockers•Non-selective may have benefit on autonomic effects of PTSD

Propranolol

Anti-depressants•May improve mood•Improves sleep

NortriptyllineAmitryptillineParoxetineFluoxetine

AEDS

•Neuropathic pain

gabapentin•Mood lability valproic acid topirimate

AlternativesPromethazineMetoclopramideProchloroperazineTizanidineNon-medicationTrigger point injectionOccipital nerve blockPhysical therapy

Avoid narcotics& Benzos

Drug InteractionsDrug InteractionsHeadache Drug

PTSD Drug Interaction

Tricyclic Antidepressants

SSRIs1) Inc TCA levels

2) Serotonin syndrome

Triptans SSRIsSerotonin Syndrome*

Propranolol PrazosinAdditive lowering of BP, orthostasis

Tricyclic

AntidepressantsBenzodiazepine

Additive increase in sedation

Back to Ladder detailsBack to Ladder details

Activity modificationsActivity modifications ““RICE” + Lifting and positional limitationsRICE” + Lifting and positional limitations Work hours and work pacingWork hours and work pacing Rotation of repetitive tasksRotation of repetitive tasks Ergonomic adjustmentsErgonomic adjustments Biomechanical optimizationBiomechanical optimization Graduated return to workGraduated return to work

Topical modalitiesTopical modalities

IceIce HeatHeat Topical analgesicsTopical analgesics

CapsaicinCapsaicin LidodermLidoderm Camphor, menthol and salicylates ( Ben-gay)Camphor, menthol and salicylates ( Ben-gay)

Ultrasound or Iontophoresis ( steroids/NSAIDs)Ultrasound or Iontophoresis ( steroids/NSAIDs) TENS unitTENS unit E-stim, Biovest, Alpha stimE-stim, Biovest, Alpha stim Cold laserCold laser

Gait and mobility aidesGait and mobility aides

CaneCane Walker incl. Rolling walker w/ fold-down Walker incl. Rolling walker w/ fold-down

seatseat Wheelchair ( manual vs. electric)Wheelchair ( manual vs. electric)

ScooterScooter

OrthoticsOrthotics

Lumbar supportLumbar support Wrist splint +/- thumb spicaWrist splint +/- thumb spica Elbow pads, arm slingElbow pads, arm sling Soft cervical collarSoft cervical collar Knee brace – hinged/unhingedKnee brace – hinged/unhinged Ankle brace or AFOAnkle brace or AFO PTB AFOPTB AFO Shoe orthotic inserts, sole modificationsShoe orthotic inserts, sole modifications

PT + HEPPT + HEP

Stretching/ROM/soft tissue mobilizationStretching/ROM/soft tissue mobilization Strengthening – Isometric -> IsotonicStrengthening – Isometric -> Isotonic Work or activity - specific trainingWork or activity - specific training PlyometricsPlyometrics Basic or modified aerobic reconditioningBasic or modified aerobic reconditioning

Walking/treadmill - graduatedWalking/treadmill - graduated Bike riding – upright/recumbentBike riding – upright/recumbent Aquatic – basedAquatic – based Cardiopulmonary parametersCardiopulmonary parameters

Massage TherapyMassage Therapy

Craniosacral techniques for TBICraniosacral techniques for TBI

ChiropracticChiropractic

ManipulationManipulation ModalitiesModalities

Basic Selfcare – Health habitsBasic Selfcare – Health habits

Obesity – dietObesity – diet SmokingSmoking AlcoholAlcohol Drug abuseDrug abuse Sleep hygieneSleep hygiene Stress managementStress management

Basic analgesicsBasic analgesics

Acetaminophen ( NTE 4000 mg/day)Acetaminophen ( NTE 4000 mg/day) Hepatic caveatsHepatic caveats

ASA ASA GI monitoringGI monitoring

NSAIDsNSAIDs SalicylatesSalicylates

Non-acetylated ( Salsalate, Disalcid, Trilisate)Non-acetylated ( Salsalate, Disalcid, Trilisate) Propionic acidsPropionic acids

Ibuprofen, Naproxen, ketoprofen, OxaprasinIbuprofen, Naproxen, ketoprofen, Oxaprasin Acetic acidsAcetic acids

Indomethacin, diclofenac, sulindac, toradolIndomethacin, diclofenac, sulindac, toradol OxicamsOxicams

PiroxicamPiroxicam Cox-2 InhibitorsCox-2 Inhibitors

CelebrexCelebrex Xyflamend – herbal - OTCXyflamend – herbal - OTC

Muscle relaxantsMuscle relaxants

Cyclobenzaprine ( TCA)Cyclobenzaprine ( TCA) Parafon forte, methocarbamol, carisoprodolParafon forte, methocarbamol, carisoprodol DantriumDantrium BaclofenBaclofen TizandineTizandine DiazepamDiazepam

Caveat re sedation and liver functionCaveat re sedation and liver function Soma – ( and valium) dependency Soma – ( and valium) dependency

Neuropathic agentsNeuropathic agents

AntidepressantsAntidepressants TCA – ami/nortriptyline, trazodone, TCA – ami/nortriptyline, trazodone,

desipraminedesipramine SSRI’s:SSRI’s: SNRI’s: venlafaxine, duloxetineSNRI’s: venlafaxine, duloxetine

Neuropathic agentsNeuropathic agents

Anti-epileptic drugs:Anti-epileptic drugs: Carbamazepine, oxcarbazepineCarbamazepine, oxcarbazepine Topiramate, KeppraTopiramate, Keppra Gabapentin ( Neurontin)Gabapentin ( Neurontin) Pregabalin ( Lyrica)Pregabalin ( Lyrica)

Watch for CNS SE, drug interactions esp Watch for CNS SE, drug interactions esp tegretoltegretol

LFT and WBC monitoring LFT and WBC monitoring

Oral steroidsOral steroids

Medrol dospak ( Methylprednisolone)Medrol dospak ( Methylprednisolone)

Prednisone taper ( 40 mg -> 0 over 12 d)Prednisone taper ( 40 mg -> 0 over 12 d)

GI, DM, cataract, osteoporosisGI, DM, cataract, osteoporosis

But also watch out for Bipolar d/o But also watch out for Bipolar d/o

NarcoticsNarcotics

Pseudo-narcoticPseudo-narcotic Tramadol – mu agonist activityTramadol – mu agonist activity

Mild analgesiaMild analgesia

Watch for serotonin syndrome w/ SSRI’sWatch for serotonin syndrome w/ SSRI’s Habit-formingHabit-forming

NarcoticsNarcotics

MildMild

Propoxyphene ( Darvocet/Darvon)Propoxyphene ( Darvocet/Darvon) No efficacy > tylenol – removed from marketNo efficacy > tylenol – removed from market

Codeine Codeine Poor GI tolerancePoor GI tolerance 2-10 % transformation to morphine2-10 % transformation to morphine

NarcoticsNarcotics

Short-actingShort-acting Oxycodone – schedule IIOxycodone – schedule II Hydrocodone – schedule III-> IIHydrocodone – schedule III-> II Meperidine ( Demerol)Meperidine ( Demerol) Hydromorphone ( Dilaudid)Hydromorphone ( Dilaudid)

• Avoid for chronic pain – rapid accommodationAvoid for chronic pain – rapid accommodation Morphine IRMorphine IR

NarcoticsNarcotics

Long-actingLong-acting OxyContinOxyContin Morphine SR, MS ContinMorphine SR, MS Contin Avinza, OpanaAvinza, Opana MethadoneMethadone Fentanyl patch or lollipopFentanyl patch or lollipop Tapentadol (Nucynta)Tapentadol (Nucynta)

Narcotic SENarcotic SE

CommonCommon N/VN/V Constipation – proactive bowel regimenConstipation – proactive bowel regimen Sedation *** Key to avoid in TBI**Sedation *** Key to avoid in TBI** ItchingItching Physiologic/psychological dependencePhysiologic/psychological dependence SweatingSweating AnorexiaAnorexia MyoclonusMyoclonus

Narcotic SENarcotic SE

MyoclonusMyoclonus Dizziness/orthostasisDizziness/orthostasis AccommodationAccommodation Respiratory suppressionRespiratory suppression Cardiac dysrhythmia – methadoneCardiac dysrhythmia – methadone

Methadone also difficult to achieve Methadone also difficult to achieve equianalgesic dosing + occ idiosyncratic buildup equianalgesic dosing + occ idiosyncratic buildup w/ long ½ life > analgesic effectw/ long ½ life > analgesic effect

Narcotic IssuesNarcotic Issues

Avoid as unimodal pharmacologic approach – Avoid as unimodal pharmacologic approach – opioid sparing conceptopioid sparing concept

Possible opioid hyperalgesiaPossible opioid hyperalgesia May need to rotate type of narcotic if May need to rotate type of narcotic if

accommodatedaccommodated Addiction vs Pseudo-addiction ( UDS)Addiction vs Pseudo-addiction ( UDS) Dependency – physiologic/psychologicDependency – physiologic/psychologic Taper ( 50 %/week) vs. DetoxTaper ( 50 %/week) vs. Detox Buprenex vs. methadone maintenanceBuprenex vs. methadone maintenance

PTSD Re-experiencingAvoidance Social withdrawal Memory gapsApathy

Mild TBIResidua

Difficulty with decisionsMental slownessConcentrationHeadachesDizzyAppetite changesFatigueSadnessSuicidality

Altered Arousal Sensitive to noise Concentration Insomnia Irritability

Depression

Substance Use (Poly)

Pain

Medication effectsPain

Conservative Conservative management of pain management of pain

after TBIafter TBI

Rachel Heberling, MDRachel Heberling, MD

Cincinnati VA Medical CenterCincinnati VA Medical Center

University of CincinnatiUniversity of Cincinnati

Why Conservative Pain Why Conservative Pain Management in TBI?Management in TBI?

Increased sensitivity to medicationsIncreased sensitivity to medications Increased difficulty managing medications, Increased difficulty managing medications,

especially prn’sespecially prn’s Increased self-efficacy via self-Increased self-efficacy via self-

managementmanagement Potentially decreased number of office Potentially decreased number of office

visitsvisits Cost-effectiveCost-effective

HeatHeat

Superficial heat: heating pad, hot shower, Superficial heat: heating pad, hot shower, hot bathhot bath

Deep heat: ultrasoundDeep heat: ultrasound

Effective for pain relief, increased muscle Effective for pain relief, increased muscle flexibilityflexibility

Not much evidence, but obviously effective Not much evidence, but obviously effective brieflybriefly

ColdCold

Superficial: Ice packsSuperficial: Ice packs Deep: cold laserDeep: cold laser

Cold effective for pain relief and reducing Cold effective for pain relief and reducing inflammation, but contracts musclesinflammation, but contracts muscles

Unclear mechanism and efficacy of cold Unclear mechanism and efficacy of cold laserlaser

STRETCHING!STRETCHING!

Muscle has viscoelastic propertiesMuscle has viscoelastic properties Slow, deep stretch paired with deep Slow, deep stretch paired with deep

breathing necessarybreathing necessary Muscle properties change for ~10 hrs after Muscle properties change for ~10 hrs after

deep stretchdeep stretch

Evidence not compelling, but pain-relief Evidence not compelling, but pain-relief effect of stretching is very obvious clinicallyeffect of stretching is very obvious clinically

Stretching!Stretching!

Other types of ExerciseOther types of Exercise

Aerobic exercise – has huge role in Aerobic exercise – has huge role in decreasing muscle tension and decreasing muscle tension and consequent pain.consequent pain.

Strength training – some role in Strength training – some role in decreasing pain (e.g. core strengthening), decreasing pain (e.g. core strengthening), but generally minimized until pain but generally minimized until pain beginning to improve.beginning to improve.

MeditationMeditation

Increasing base of evidence for the pain Increasing base of evidence for the pain relief effects of meditationrelief effects of meditation

Decreases stressDecreases stress Improved emotional acceptance of painImproved emotional acceptance of pain

YogaYoga

EXCELLENT choice for exercise EXCELLENT choice for exercise maintenancemaintenance

Has role in decreasing active pain issues Has role in decreasing active pain issues as well.as well.

Must start in beginner class! Must start in beginner class!

Advanced Yoga ClassAdvanced Yoga Class

Tai ChiTai Chi

Becoming more popular topic of researchBecoming more popular topic of research Have found that Tai Chi practice Have found that Tai Chi practice

decreases falls in the elderlydecreases falls in the elderly Somewhat similar to yoga, but more Somewhat similar to yoga, but more

focused on gentle fluid movement, as focused on gentle fluid movement, as opposed to deep prolonged stretchopposed to deep prolonged stretch

Physical TherapyPhysical Therapy

Many treatment modalities availableMany treatment modalities available StretchingStretching StrengtheningStrengthening UltrasoundUltrasound TENSTENS TractionTraction

Bracing & Assistive DevicesBracing & Assistive Devices

Lumbar supportLumbar support Knee bracesKnee braces CaneCane WalkerWalker

AcupunctureAcupuncture

AcupunctureAcupuncture

WHO, NIH Consensus StudyWHO, NIH Consensus Study

Classified disease Classified disease processes according to processes according to evidence for evidence for acupuncture efficacyacupuncture efficacy

20032003

ProvenProven Needs further researchNeeds further research Worth tryingWorth trying

Diseases, symptoms or conditions for which acupuncture Diseases, symptoms or conditions for which acupuncture has been PROVEN-through controlled trials-to be an has been PROVEN-through controlled trials-to be an

effective treatment:effective treatment:

Adverse reactions to radiotherapy Adverse reactions to radiotherapy and/or chemotherapyand/or chemotherapyAllergic rhinitis (including hay Allergic rhinitis (including hay fever)fever)Biliary colicBiliary colicDepression Depression (including (including depressive neurosis and depressive neurosis and depression following stroke)depression following stroke)Dysentery, acute bacillaryDysentery, acute bacillaryDysmenorrhoea, primaryDysmenorrhoea, primaryEpigastralgia, acute (in peptic Epigastralgia, acute (in peptic ulcer, acute and chronic gastritis, ulcer, acute and chronic gastritis, and gastrospasm)and gastrospasm)Facial pain (including Facial pain (including craniomandibular disorders)craniomandibular disorders)HeadacheHeadacheHypertension, essentialHypertension, essentialHypotension, primaryHypotension, primary

Induction of labourInduction of labourKnee painKnee painLeukopeniaLeukopeniaLow back painLow back painMalposition of fetus, correction ofMalposition of fetus, correction ofMorning sicknessMorning sicknessNausea and vomitingNausea and vomitingNeck painNeck painPain in dentistry (including dental Pain in dentistry (including dental pain and temporomandibular pain and temporomandibular dysfunction)dysfunction)Periarthritis of shoulderPeriarthritis of shoulderPostoperative painPostoperative painRenal colicRenal colicRheumatoid arthritisRheumatoid arthritisSciaticaSciaticaSprainSprainStrokeStrokeTennis elbowTennis elbow

WHO Acupuncture and The NIH Consensus Study

Diseases, symptoms or conditions for which the Diseases, symptoms or conditions for which the therapeutic effect of acupuncture has been shown but therapeutic effect of acupuncture has been shown but

for which FURTHER PROOF IS NEEDED:for which FURTHER PROOF IS NEEDED: Abdominal pain (in acute Abdominal pain (in acute

gastroenteritis or due to gastroenteritis or due to gastrointestinal spasm)gastrointestinal spasm)Acne vulgarisAcne vulgarisAlcohol dependence and Alcohol dependence and detoxificationdetoxificationBell’s palsyBell’s palsyBronchial asthmaBronchial asthmaCancer painCancer painCardiac neurosisCardiac neurosisCholecystitis, chronic, with acute Cholecystitis, chronic, with acute exacerbationexacerbationCholelithiasisCholelithiasisCompetition stress syndromeCompetition stress syndromeCraniocerebral injury, closedCraniocerebral injury, closedDiabetes mellitus, non-insulin-Diabetes mellitus, non-insulin-dependentdependentEaracheEaracheEpidemic haemorrhagic feverEpidemic haemorrhagic feverEpistaxis, simple (without Epistaxis, simple (without generalized or local disease)generalized or local disease)

Eye pain due to subconjunctival Eye pain due to subconjunctival injectioninjectionFemale infertilityFemale infertilityFacial spasmFacial spasmFemale urethral syndromeFemale urethral syndromeFibromyalgia and fasciitisFibromyalgia and fasciitisGastrokinetic disturbanceGastrokinetic disturbanceGouty arthritisGouty arthritisHepatitis B virus carrier statusHepatitis B virus carrier statusHerpes zoster (human (alpha) Herpes zoster (human (alpha) herpesvirus 3)herpesvirus 3)HyperlipaemiaHyperlipaemiaHypo-ovarianismHypo-ovarianismInsomniaInsomniaLabour painLabour painLactation, deficiencyLactation, deficiencyMale sexual dysfunction, non-Male sexual dysfunction, non-organic Ménière diseaseorganic Ménière diseaseNeuralgia, post-herpeticNeuralgia, post-herpetic

WHO Acupuncture and The NIH Consensus Study

Diseases, symptoms or conditions for which the Diseases, symptoms or conditions for which the therapeutic effect of acupuncture has been shown but therapeutic effect of acupuncture has been shown but

for which FURTHER PROOF IS NEEDED:for which FURTHER PROOF IS NEEDED:

NeurodermatitisNeurodermatitisObesityObesityOpium, cocaine and heroin Opium, cocaine and heroin dependencedependenceOsteoarthritisOsteoarthritisPain due to endoscopic Pain due to endoscopic examinationexaminationPain in thromboangiitis obliteransPain in thromboangiitis obliteransPolycystic ovary syndrome (Stein-Polycystic ovary syndrome (Stein-Leventhal syndrome)Leventhal syndrome)Postextubation in childrenPostextubation in childrenPostoperative convalescencePostoperative convalescencePremenstrual syndromePremenstrual syndromeProstatitis, chronicProstatitis, chronicPruritusPruritusRadicular and pseudoradicular Radicular and pseudoradicular pain syndromepain syndromeRaynaud syndrome, primaryRaynaud syndrome, primary

Recurrent lower urinary-tract Recurrent lower urinary-tract infectioninfectionReflex sympathetic dystrophyReflex sympathetic dystrophyRetention of urine, traumaticRetention of urine, traumaticSchizophreniaSchizophreniaSialism, drug-inducedSialism, drug-inducedSjögren syndromeSjögren syndromeSore throat (including tonsillitis)Sore throat (including tonsillitis)Spine pain, acuteSpine pain, acuteStiff neckStiff neckTemporomandibular joint Temporomandibular joint dysfunctiondysfunctionTietze syndromeTietze syndromeTobacco dependenceTobacco dependenceTourette syndromeTourette syndromeUlcerative colitis, chronicUlcerative colitis, chronicUrolithiasisUrolithiasisVascular dementiaVascular dementiaWhooping cough (pertussis)Whooping cough (pertussis)

WHO Acupuncture and The NIH Consensus Study

Diseases, symptoms or conditions for which there are Diseases, symptoms or conditions for which there are only individual controlled trials reporting some only individual controlled trials reporting some

therapeutic effects, but for which acupuncture is WORTH therapeutic effects, but for which acupuncture is WORTH TRYING because treatment by conventional and other TRYING because treatment by conventional and other

therapies is difficult:therapies is difficult:

ChloasmaChloasma

Choroidopathy, central Choroidopathy, central serousserous

Colour blindnessColour blindness

DeafnessDeafness

HypophreniaHypophrenia

Neuropathic bladder in Neuropathic bladder in spinal cord injuryspinal cord injury

Pulmonary heart disease, Pulmonary heart disease, chronicchronic

Small airway obstruction Small airway obstruction

Irritable colon syndromeIrritable colon syndrome

GERAC – DesignGERAC – Design Journal of Alternative and Complementary MedicineJournal of Alternative and Complementary Medicine. Volume 12, Number . Volume 12, Number

8, 2006. pp 733-428, 2006. pp 733-42

German Acupuncture Trials for Low Back PainGerman Acupuncture Trials for Low Back Pain 1162 patients in Germany at 340 centers1162 patients in Germany at 340 centers Chronic non-specific low back pain >6 monthsChronic non-specific low back pain >6 months Compared verde vs sham vs conventional Compared verde vs sham vs conventional

guideline-based treatmentguideline-based treatment Semi-standardized verde acupuncture Semi-standardized verde acupuncture

treatment protocoltreatment protocol

GERAC – DesignGERAC – Design

10 sessions over 10 weeks regardless of 10 sessions over 10 weeks regardless of groupgroup

5 additional sessions for partial 5 additional sessions for partial responders (>10%, <50% improvement)responders (>10%, <50% improvement)

Limited communication with acupuncturist Limited communication with acupuncturist to avoid unblindingto avoid unblinding

Allowed NSAID for rescue, max twice Allowed NSAID for rescue, max twice weekly.weekly.

GERAC - ResultsGERAC - ResultsTable 4. Primary Outcome: Pairwise Comparisonof Treatment Response 6 Months After Randomization

Treatment Response Intergroup Difference P ValueGroup 1 vs group 347.6 (42.4 to 52.6) vs 20.2 (13.4 to 26.7) 0.00127.4 (23.0 to 32.1)

Group 2 vs group 344.2 (39.2 to 49.3) vs 16.8 (10.1 to 23.4) 0.00127.4 (23.0 to 32.1)

Group 1 vs group 2 3.4 (−3.7 to 10.3) 0.3947.6 (42.4 to 52.6) vs 44.2 (39.2 to 49.3)

GERAC - ResultsGERAC - Results Treatment Response After 6 MonthsTreatment Response After 6 Months Conventional Sham Acupuncture Verum AcupunctureConventional Sham Acupuncture Verum Acupuncture CPGSCPGS Success 132 (34.1) 197 (50.9) 229 (59.2)Success 132 (34.1) 197 (50.9) 229 (59.2) HFAQHFAQ Success 195 (50.4) 251 (64.9) 281 (72.6)Success 195 (50.4) 251 (64.9) 281 (72.6) Combined CPGS and HFAQCombined CPGS and HFAQ Success 223 (57.6) 277 (71.6) 304 (78.5)Success 223 (57.6) 277 (71.6) 304 (78.5)

Combined GCPS, HFAQCombined GCPS, HFAQ Nonresponders 164 (42.4) 125 (32.3) 112 (28.9)Nonresponders 164 (42.4) 125 (32.3) 112 (28.9) Responders 223 (Responders 223 (57.657.6) 262 () 262 (67.767.7) 275 () 275 (71.171.1))

Overall treatment response including proscribed rescue medicationOverall treatment response including proscribed rescue medication Nonresponders 281 (72.6) 216 (55.8) 203 (52.4)Nonresponders 281 (72.6) 216 (55.8) 203 (52.4) Responders 106 (27.4) 171 (44.2) 184 (47.6)Responders 106 (27.4) 171 (44.2) 184 (47.6)