Acupuncture for Phantom Limb Pain

Study Overview
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Brief Summary
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Phantom pain is a common complication following limb amputation, and is thought to result from a system of pathophysiological mechanisms - peripheral, spinal, central and psychological. Treatment is primarily medical, using antidepressant and anticonvulsant medications. At present, there is no evidence-based approach for the management of phantom limb pain (PLP). Acupuncture is an ancient Chinese treatment during which thin needles (diameter 0.20-0.30mm) are inserted into various points on the skin. Studies of this treatment have found significant benefit in a number of conditions with chronic pain. We propose a randomized, double-blind, placebo/sham -controlled study to evaluate whether acupuncture is an effective and safe modality for preventing and reducing PLP in patients following lower limb amputation. Patients requiring lower limb amputation (above-ankle) will be randomized into two groups, for real or placebo/sham acupuncture treatment. Both groups will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture treatment protocol, using either true or placebo needles at sham acupuncture points, for a period of four weeks (eight treatments). The primary outcome to be evaluated will be PLP at 4 weeks, using a site-specific numerical rating pain scale (ss-NRS). Secondary outcome measures to be evaluated are: stump pain (ss-NRS); analgesic use (Tramadol, 100mg Tablet); and depressive symptoms, using the Beck Depression Score. Blinding of the participants will be evaluated using a Validation of Blinding Questionnaire at the end of the treatment period.

Official Title
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Acupuncture for Phantom Limb Pain: A Randomized, Double-Blind, Placebo/Sham - Controlled Study

Conditions
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Phantom Limb Pain

Intervention / Treatment
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* Procedure: acupuncture
* Other: placebo/sham acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of either gender Age 18 years and older Scheduled for lower single limb amputation (above or below knee) Ability to comply with study protocol Exclusion Criteria: Patients requiring limb amputation due to trauma Patients displaying symptoms of overt Axis-1 psychopathology such as Schizophrenia or Substance Abuse Inability to comply with the study protocol Previous experience with acupuncture treatment; current use of complementary or alternative medical treatments.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>true acupuncture | Procedure: acupuncture<br>* 2 treatments/week for 4 weeks<br>|
| Placebo Comparator: 2<br>placebo/sham acupuncture | Other: placebo/sham acupuncture<br>* 2 treatments/week for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the effect of acupuncture on phantom limb pain at 3 months post-amputation |  | 3 months | 
| To study the effect of acupuncture on stump pain at 4 weeks post-amputation |  | 4 weeks | 
| To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation |  | 4 weeks | 
| To study the effect of acupuncture on parameters of depression (using the Beck Depression Score) at 4 weeks and 3 months post-amputation |  | 4 weeks and 3 months | 
| To study the safety of acupuncture treatment in patients following amputation with phantom limb pain |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, amputation, phantom limb pain