neuropathic pain - evidence based.pdf

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NZ Journal of Physiotherapy July 2009, Vol. 37 (2)68

Invited Clinical Commentary

Neuropathic pain: an evidence-based update

Leica Sarah ClaydonLecturer, REAL Neurology Research Group, Centre for Physiotherapy Research,

University of Otago, Dunedin, New Zealand

ABSTRACTCommon conditions affecting New Zealanders (e.g. diabetes, stroke, cancer) cancause neuropathic pain (NeP). NeP can be managed in primary or secondary care.

The Health Strategy of New Zealand identified the need to reduce the impact ofthese conditions as a health priority, and targeted primary care as a service deliveryarea. With this health context in mind, a critique of recent literature concerning keyquestions surrounding neuropathic pain is provided in this paper. Key guidelines anddata from systematic reviews are used in response to these questions. Evidencepoints to the need for a psychosocial approach in the management of NeP; notonly the fact that 30-40% of patients can expect >50% pain relief, but also the impactof NeP on many areas of patients health related quality of life and the experiencesof patients with NeP. In management guidelines, physiotherapy is cited as a keycomponent of management. There are multiple research opportunities to investigatethe effects of physiotherapy for patients with NeP, particularly in combination withpharmacological approaches to management. Claydon LS (2009): Neuropathicpain: an evidence-based update. New Zealand Journal of Physiotherapy 37(2):68-74.Key Words: Neuropathic pain, Somatosensory system, sensory neuropathy, neuralgia,review

BACKGROUNDNeuropathic pain (NeP) is defined by the

International Association for the Study of Pain(IASP) as pain arising as a direct consequence ofa lesion or disease affecting the somatosensorysystem (Loeser and Treede, 2008). Symptoms of NePoften include a reported lack of sensation in the areaand pain, with the pain being described as electric-like or lancinating. Common conditions such as

diabetes, stroke, multiple sclerosis and cancer cancause NeP (Table 1). The World Health Organisationindicates that chronic or long term conditionsincluding diabetes, cardiovascular disease andcancer, are the leading cause of preventablemorbidity and mortality in New Zealand (WHO,2008). The New Zealand Health Strategy (2000)prioritizes the reduction, impact and incidence ofthese conditions, and has targeted primary care asa service delivery area. It is however, anticipatedthat NeP may become more prevalent in yearsto come due to: an aging population, increased

survival rates of conditions such as diabetes andcancer, and use of treatment strategies (for examplemedical and surgical management of cancer) whichcan cause NeP (Dworkin, 2002). This clinicalcommentary provides a critique of recent literaturein response to key questions health care consumersand providers, such as physiotherapists, may haveas regards NeP.

How many people have neuropathicpain?

Prevalence may be defined as the total numberof cases (of the condition) in the population at agiven time (Collins, 2009). A systematic reviewof the prevalence of NeP, and for NeP associatedwith specific conditions (Table 1) according toworld regions, settings and populations (Gagnon

et al, 2007). Seventy-nine studies were includedin the systematic review however only three wereconducted in the general population: one in theUSA (reporting prevalence of 0.021% for complexregion pain syndrome (CRPS) I and 0.009% forCRPS II), one in the UK (reporting prevalence ofprobable NeP of 8.2%) and one in India (reportingprevalence of peripheral neuropathies) (Gagnon etal, 2007). Both USA and Indian data are based NePcaused by one or two conditions whereas UK datais based on probable NeP in the general population.

The authors concluded that prevalence of NeP inthe general population was higher than previouslythought, although this needs to be confirmed ingeneral populations of countries other than theUK. Therefore although the exact prevalence of NePin New Zealand is unknown, extrapolating the UKgeneral population figure of 8.2% to New Zealandsuggests there may be nearly 340 000 people withNeP (based on general population of 4,143,279people from 2006 Census (Statistics New Zealand,2006)).

What is the impact of neuropathicpain?The impact of NeP on health-related quality of life

(HRQOL) was recently systematically reviewed by

Table 1: Common causes of NeP (adapted from Dworkin 2002)Chemotherapy-induced neuropathyComplex regional pain syndromeHIV sensory neuropathyNeuropathy secondary to tumor infiltrationPainful diabetic neuropathyPhantom limb painPost-herpetic neuralgiaCentral post-stroke painMultiple sclerosis painParkinsons disease pain

Spinal cord injury pain


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NZ Journal of Physiotherapy July 2009, Vol. 37 (2) 69

Jensen and colleagues (2007). Fifty two studies wereidentified which examined the association betweena wide variety of HRQOL domains and NeP. One ofthese studies is presented in Figure 1 to illustratethe percentage of people with moderate to severepain and the association with HRQOL variables.These studies commonly use HRQOL measures

such as the SF-36 and the Brief Pain Inventory.The SF-36 is a generic measure with 8 dimensionscovering physical function, physical role, bodilypain, general health, mental health, emotional role,social function and vitality (Ware, 2009). The BriefPain Inventory is a 17 item self-rated scale whichincludes demographic data, medication use andthe sensory and reactive components of pain (Kelleret al, 2004). It comprises numeric rating scales(0-10), with moderate pain severity as 4-6, andsevere pain as 7-10. Results from the systematicreview indicated that pain presence and severitywas significantly associated with impairments in

physical functioning and had a negative impact onemotional functioning (Jensen et al, 2007). Painpresence was also significantly associated withsleep interference and a negative impact on roleand social functioning. Peripheral and central NePconditions (for example painful diabetic neuropathyand post-stroke pain, respectively) showed similarassociations between pain severity and HRQOL.The authors conclude that the negative effects ofNeP on physical, social, and emotional HRQOLdomains indicates the needs for a psychosocialapproach to the assessment and management

of NeP. As associations were generally strongerwith pain-specific measures of HRQOL such asthe Brief Pain Inventory compared to the SF-36physical function subscale, the authors suggestthe brief pain inventory maybe a useful tool inclinical practice and clinical trials. Limitations ofthe reviewed research were that almost all studieswere descriptive or correlational designs thereforecausal relationships could not be established.

It is unclear whether HRQOL can predict treatmentoutcome. One study investigated whether HRQOLcould predict analgesic effect of treatment in patientswith painful polyneuropathy (Otto et al, 2007). Datafrom 93 patients were included in the analysis andwere obtained from three randomized, placebo-controlled studies testing the effect of different drugs

on pain. Patients completed the SF-36 at baseline (notreatment period) and at the end of each treatment.At baseline all SF-36 scores were lower than thenormal population and regression analysis indicatedthat baseline scores predicted response to treatment.The authors reported that they could not identifyany other studies on HRQOL predicting treatmentoutcome in chronic pain conditions.

What are patient experiences ofneuropathic pain?

Qualitative research focuses on answeringthe why and how questions (Kuper et al,2008a). Qualitative research aims to generatein-depth accounts from individuals or groups,with data usually being gathered via interviews(semistructured or unstructured); focus groups, orobservations (Kuper et al, 2008b). Data analysisis usually inductive (reasoning by drawing generalrules from individual cases) allowing meaning toemerge from the data as opposed to deductive

hypothesis driven quantitative approaches (Kuperet al, 2008b). Qualitative research surroundingpatient experiences of NeP includes impacton relationships (Closs et al, 2009), socialconsequences (Sofaer-Bennett et al, 2007) andmanaging symptoms (Closs et al, 2007).

Themes which emerged from the data concerningthe social impact of NeP include: the loss of abilityto maintain established roles leading to feelingsof guilt, inadequacy and frustration (Closs et al,2009), social isolation (Closs et al, 2009, Sofaer-Bennett et al, 2007) and the invisibility of pain

causing issues with communication and theresultant fear of being labeled mentally ill (Closset al, 2009). Themes which emerged from the dataconcerning symptomatic management included:self management using alternative strategies,conventional medications, and trying to acceptpain adjusting to the situation (Closs et al, 2007).Repeated cycles of seeking help to manage painwere also described with each unsuccessful attemptfollowed by new attempts (Closs et al, 2007)...Iwas four years trying all different medications to try

and control the pain.they werent any good really

.(Closs et al 2007, p426).Patients reported littleor no psychological, social, emotional or practical

support to help them try to accept their pain (Closset al, 2007).The researchers may be commended forthe credibility of their research in establishing theexperiences of patients with NeP, their criticalityof investigating alternative theories that includeda critical examination of deviant cases, andintegrity of the number of repetitive checks of bydifferent authors of the data to explore alternativemeanings. The authors of these qualitative studiesall suggested that there is a need to validate thetheoretical findings that they proposed in larger

studies. These studies were conducted in the UKtherefore it is unclear whether all the findings mightbe applicable or transferable to the health carecontext of New Zealand.

Figure 1: Study by McDermott et al: 2006 Burden of NeP: resultsfrom a cross-sectional survey

A cross-sectional survey of 602 patients with NeP (from sixcountries) was conducted

Patients reported functional health, well-being,painexperience, and health care utilization using the brief paininventory (see text), and completed a score regardingHRQOL (EuroQol)

The mean age of patients was 62.9 years. Most patients reported moderate (54%) or severe pain

(25%) on the BPI. Pain severity was associated with poorer EuroQol scores 93% of patients took medications, 76% visited the physician

at least once a month, and 9.8% missed an average of5.5 days of employment.


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Definite neuropathic pain: The possiblecriteria and both of the probable criteria.

The medical history, pain distribution on a bodydrawing, and sensory testing are pivotal to thesediagnostic criteria. Studies to provide evidence (ornot) for these criteria are required as currently thereis level C evidence (retrospective study evaluated bya blinded assessor) for bed side sensory testing and

quantitative sensory testing has never been used tomake a differential diagnosis between NeP and NPpains (Cruccu et al, 2004). An important questionto ask is where do screening tools fit in thisgrading system? Treede (et al, 2008 p1634) statethat future studies are required to determine theutility of this grading system and possible necessity

for revision, for example by including symptoms in the

grading. The authors should be commended for thisclassification system as opposed to the alternativesituation whereby the neuropathic pain syndromeis stated and it is assumed that pain is NeP. Themain screening tools to differentiate NP and NeP are

listed in table two, along with an indication of theclassification criteria they may satisfy.

What are current managementstrategies for neuropathic pain?

CREST guidelines recommend that the evaluationof NeP (in addition to diagnosis, cause of NePand history) should include 1) location, quality,intensity, and duration of pain; 2) functionalimpact include activities and sleep pattern; 3)psychological factors including effect on mood; and4) response to previous treatment (CREST, 2008).

NeP can be managed in primary or secondary care.Initial treatment options for NeP include: (1) non-pharmacological options, as these have the lowestrisk of side affects and must be offered early, withpossible referral to physiotherapy, occupationaltherapy, psychology (if predominantly psychologicalissues) or a pain management programme (ifsignificant physical, social, and functional issues),and (2) pharmacological interventions such asunconventional and conventional analgesics(CREST, 2008).

What is the evidence-base for thesestrategies?For strategies other than physiotherapy, key

guidelines or the most recent systematic reviewsare used for evidence. For physiotherapy searcheswere conducted for systematic reviews in thisarea. Few studies were indexed under the headingneuropathic pain therefore Mesh (medical subjectword headings) headings of NeP conditions wereused (e.g. Complex regional pain syndrome,neuropathy) and physiotherapy using the searchstrategy identified by Montori (2005) in MEDLINEvia Pubmed.

Pharmacological interventionsEvidence-based pharmacological strategies for

the management of NeP suggest that first line

treatments may be: antidepressants (tricyclicsor dual re-uptake inhibitors of serotonin ornoradrenaline), calcium channel 2- ligands(gabapentin and pregabalin), local anaesthetic typedrugs (lidocaine), and opioids (Dworkin et al, 2007).These recommendations are based on randomizedcontrolled trial data. However, it should be notedthat only 30-40% of patients will receive >50% pain

relief. Recommendations for trials investigatingcombinations of pharmacological treatments and/or pharmacological and non-pharmacologicaltreatments have therefore been made (Dworkin etal, 2007).

Non-Pharmacological interventionsThis section primarily focuses on physiotherapy,

spinal cord stimulation, and pain managementprogrammes as recommended in the CRESTguidelines for the management of NeP (2008).

PhysiotherapyNeuropathic pain and physiotherapy

A systematic review of complementary therapiesfor NeP and neuralgia pain included randomizedcontrolled trials (RCTs) and systematic reviewsfor acupuncture and electrostimulation (includingtranscutaneous electrical nerve stimulation(TENS)) (Pittler and Ernst, 2008). Three RCTswere identified which investigated acupuncture.No analgesic benefit of acupuncture comparedto mock TENS was reported (Hempenstall et al,2005), or acupuncture compared to placebo (Shlayet al, 1998) for post-herpetic neuralgia and HIV

induced peripheral neuropathy, respectively. Thethird RCT compared two forms of needling andfound deep needling to increase the therapeuticeffect in trigeminal neuralgia (Zhang, 2005). Thisreview indicates there is little evidence for the useof acupuncture in NeP conditions. Future trialsshould use an appropriate sham needle (ratherthan mock TENS) and dosage of acupuncture beforethe efficacy of this modality is known (White et al2008). Four RCTs were identified which investigatedelectrostimulation (TENS with electrodes or PENSwith needles) (Pittler and Ernst, 2008). They foundthat pain scores improved compared to baseline(Forst et al, 2004; Hamza et al, 2000) or placebo(Kumar et al, 1997; Cheing and Luk, 2005) indiabetic neuropathy or hypersensitivity of the hand.Although these results are encouraging, it is alsonot reported which stimulation parameters wereused. A review of systematic reviews on TENS andchronic pain (osteoarthritis, rheumatoid arthritis,low-back pain) found that two out of six reviewsreported that high intensity (strong but tolerable)intensities of TENS were more effective compared toplacebo than low intensity (strong but comfortable)applications (Claydon and Chesterton, 2008).

These results were based on a total of eight highquality (adequate randomization and blinding)trials which used validated pain intensity or reliefvisual analogue (VAS) or numeric rating scales


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(NRS) as the outcome measure. The systematicreview by Pittler and Ernst (2008) did not rate thestudies for quality and did not report the searchstrategy (inclusion criteria and sources searched).It appears that systematic reviews for TENS andchronic pain may have not extensively searchedfor various neuropathic as opposed to nociceptiveconditions.

Complex r eg iona l pa in syndrome and

physiotherapy

A systematic review recently reported on theeffectiveness of physiotherapy management foradult complex regional pain syndrome (CRPS) type I(Daly and Bialocerkowski, 2009). The authors foundthat a six week graded motor imagery programmeis effective in reducing pain by a clinically relevantamount, and this effect is maintained for 6 months.This evidence was graded as good to very good(scored 11-14/16 on quality tool) level II (properlydesigned RCT(s)) based on the work by Moseley

(Moseley, 2004; Moseley, 2005; Moseley, 2006).The authors also reported that there is no evidenceto support frequently recommended treatments inguidelines such as stress loading.

Neuropathy and physiotherapy

Systematic reviews of interventional RCTSfor neuropathy include: Charcot-Marie-Toothdisease (Young et al, 2008), chemotherapy-induced neuropathy (Visovsky et al, 2007), andexercise for peripheral neuropathy (White et al,2004). Charcot-MarieTooth disease covers a lot of

different forms of sensory and motor neuropathies(Young et al, 2008) and the authors of thisCochrane review systematically looked for RCTsor quasiRCTs on any treatment for this disease.They found that small trials of exercise have beenperformed; however, none showed a significantbenefit. The chemotherapy-induced peripheralneuropathy systematic review included evidencefor pharmacological and non-pharmacologicalstrategies; the non-pharmacological evidence isconsidered here (Visovsky et al, 2007). The authorsreported that there are no RCTS concerningacupuncture, assistive devices, physical activityand exercise, or TENS for this type of neuropathy.The authors made treatment recommendationsbased on literature reviewed previously and onthe following Cochrane systematic review onexercise for peripheral neuropathy. The role ofexercise for individuals with peripheral neuropathy(sensory, motor or combined) found that there wasinadequate (quality) evidence to evaluate the effectof exercise in this population (White et al, 2004).Only one trial was randomized or quasi-randomisedcomparing the effects of exercise to drugs or non-pharmacological management on outcomes at least

8 weeks after randomization. The authors alsostated that pain was infrequently reported in theprimary studies.

Neuralgia and physiotherapy

A systemat ic review recent ly reported oninterventional RCTs concerning conservativetreatments (including physiotherapy) forlumbrosacral radicular syndrome (Luijsterburget al, 2007). They found that: (1) at long-termthere is no evidence in favour of corticosteroidinjections compared to placebo, (2) at short term

there is no evidence in favour of traction comparedto placebo or other treatments, (3) at short termthere is no evidence in favour of physiotherapy,bed rest, manipulation or medication compared toother treatments or surgery, and (4) no evidencewas found regarding acupuncture. The authorsstated that they could not conclude whetherclinicians should prescribe physiotherapy, bedrest, or manipulation as there was no evidence oftreatment superiority (Luijsterburg et al, 2007). Thisparallels the evidence reviewed in Cochrane reviewsconcerning bed rest in back pain and sciatica(Hagen et al, 2004) and traction in back pain with

and without sciatica (Clarke et al, 2007).

Central pain (Stroke, Multiple Sclerosis, Parkinsons

Disease) and physiotherapy

Systematic reviews on stroke pain andphysiotherapy included: supportive devices forpreventing and treating subluxation of the shoulder(Ada et al, 2005) and electrical stimulation forpreventing and treating post-stroke shoulder pain(Price and Pandyan, 2000). Ada (et al 2005) foundthat strapping the hemi-shoulder could preventthe onset of pain but not decrease pain severity.

Price and Pandyan (2000) found that electricalstimulation improved pain free lateral rotationbut did not decrease pain incidence or intensity.However it is unclear whether the pain was NeP ordue to tissue injury (NP). A search for Parkinsonsdisease and pain and physiotherapy, only resultedin a review for the treatment options for non-motor symptoms in late-stage Parkinsons (wheretreatments for dementia, psychosis, fractures andpain are considered) (Coelho et al, 2008). As regardsMultiple Sclerosis, one systematic review reportedan overview of RCTs concerning physiotherapy(Wiles, 2008). Generally the RCTs reported benefitsfor people with MS. However, it was not reportedwhich patients had pain apart from two trialsof TENS for back pain in Multiple Sclerosis, theeffects of which were negative (Warke et al, 2006;Al-Samadi et al, 2003).

Conclusion: Physiotherapy

An indication of the RCT evidence forphysiotherapy in various NeP conditions hasbeen outlined. Applying the classification of NePconsidered earlier, most RCTs stated diagnosisof the NeP condition rather than indicating pain

distribution and sensation testing making it unclearwhether NeP was present. There appears to bean absence of quality research for physiotherapymanagement of various neurological conditions


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which cause NeP, apart from the physiotherapymanagement of CRPS type I.

Spinal cord stimulationA recent health technology assessment was

commissioned to evaluate the effects of spinal cordstimulation in patients with NeP or ischaemic pain(Simpson et al, 2009). Spinal cord stimulation is

a device implanted in the epidural space whichstimulates the dorsal columns of the spinal cord,the implantation costing around $30,000 (10,000).The authors found three RCTs concerning spinalcord stimulation and NeP and concluded that it iseffective for NeP associated with failed back surgerysyndrome (persistent pain after anatomically correctsurgery) and CRPS type I (Simpson et al, 2009).

Pain management programmesRecommended guidelines for pain management

programmes in adults have been published bythe British Pain Society (BPS, 2007). The authors

of this guideline state the programmes are basedon cognitive behavioural principles and are thetreatment of choice for people with persistentpain which adversely affects their HRQOL. Theprogrammes consist of education on pain physiology,psychology, healthy function, self management,goal setting, relaxation, changing habits which arecontributing to disability, and changing unhelpfulbeliefs. The references regarding evidence ofeffectiveness for these programmes are largely basedon musculoskeletal pain, and/or any NeP componentis unspecified. The authors of this guideline state

that the majority of the patients which attend theseprogrammes have musculoskeletal pain (NP) although

a minority have NeP or central pain p13.

Conclusion- what does the futurehold?

Evidence has been reviewed concerning theprevalence of NeP, impact of NeP on HRQOL,patient experiences of NeP, and diagnostic andmanagement strategies. Key points of this revieware summarized below. With consideration for theNew Zealand scene, the following areas of research

have been highlighted, What are New Zealanders experiences ofNeP? What research would they like to beconducted in this area? What outcomes areimportant to them?

How do physiotherapists identify possibleNeP? How useful do they find the assessmentand management guidelines?

What are possible sources of variation in thescreening tools for NeP? Which tool has thehighest quality (best)?

How valid is the classification system for NeP?Does it need to include screening tools?

Is TENS effective for NeP? Is exercise effective for NeP?Studies concerning these key questions are

currently underway.

Key points:

! Neuropathic pain (NeP) may affect 340,000

New Zealanders.

! NeP affects multiple domains of life (physical,

social, and emotional function and sleep).

! Patients experience social isolation and lose the

ability to maintain established roles.

!

Patients seek management for symptoms via

conventional and unconventional treatmentsand attempt to accept the pain.

! A diagnostic classification system for NeP has

been proposed, the utility of which needs

investigating.

! Management strategies for NeP includes

pharmacological and non-pharmacological

treatments.

!

RCTs usually state the neurological condition

making it unclear whether NeP is present.

! RCT data supports the use of motor imagery

for CRPS type I; high quality RCTs appear to be

lacking in other neurological conditions which

can cause NeP.

ADDRESS FOR CORRESPONDENCE:Dr Leica Claydon, Centre for Physiotherapy Research,

University of Otago, PO Box 56, Dunedin, New Zealand, 9054.

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