Acupuncture for Phantom Limb Pain
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 true acupuncture |
Procedure: acupuncture
2 treatments/week for 4 weeks
|
| Placebo Comparator: 2 placebo/sham acupuncture |
Other: placebo/sham acupuncture
2 treatments/week for 4 weeks
|
Outcome Measures
Primary Outcome Measures
- To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation [4 weeks]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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:
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Patients requiring limb amputation due to trauma
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Patients displaying symptoms of overt Axis-1 psychopathology such as Schizophrenia or Substance Abuse
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Inability to comply with the study protocol
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Previous experience with acupuncture treatment; current use of complementary or alternative medical treatments.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shaare Zedek Medical Center | Jerusalem | Israel | 91031 |
Sponsors and Collaborators
- Shaare Zedek Medical Center
Investigators
- Principal Investigator: Noah Samuels, M.D., Shaare Zedek Medical Center, Jerusalem, Israel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACP.PLP.10.06