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| Sponsored by: |
Shaare Zedek Medical Center |
|---|---|
| Information provided by: | Shaare Zedek Medical Center |
| ClinicalTrials.gov Identifier: | NCT00460161 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Phantom Limb Pain |
Procedure: acupuncture Other: placebo/sham acupuncture |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Acupuncture for Phantom Limb Pain: A Randomized, Double-Blind, Placebo/Sham - Controlled Study |
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
true acupuncture
|
Procedure: acupuncture
2 treatments/week for 4 weeks
|
|
2: Placebo Comparator
placebo/sham acupuncture
|
Other: placebo/sham acupuncture
2 treatments/week for 4 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Israel | |
| Shaare Zedek Medical Center | |
| Jerusalem, Israel, 91031 | |
| Principal Investigator: | Noah Samuels, M.D. | Shaare Zedek Medical Center, Jerusalem, Israel |
More Information
| Responsible Party: | Shaare Zedek Medical Center ( Dr. Noah Samuels ) |
| Study ID Numbers: | ACP.PLP.10.06 |
| Study First Received: | April 12, 2007 |
| Last Updated: | February 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00460161 History of Changes |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
|
acupuncture amputation phantom limb pain |
|
Signs and Symptoms Neurologic Manifestations Pain |
Phantom Limb Neurobehavioral Manifestations Perceptual Disorders |
|
Signs and Symptoms Nervous System Diseases Neurologic Manifestations |
Phantom Limb Neurobehavioral Manifestations Perceptual Disorders |