Clinical Trial: Acupuncture for Phantom Limb Pain
Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional
Official Title: Acupuncture for Phantom Limb Pain: A Randomized, Double-Blind, Placebo/Sham - Controlled Study
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.
Detailed Summary:
Sponsor: Shaare Zedek Medical Center
Current Primary Outcome: To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation [ Time Frame: 4 weeks ]
Original Primary Outcome: To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation
Current Secondary Outcome:
- To study the effect of acupuncture on phantom limb pain at 3 months post-amputation [ Time Frame: 3 months ]
- To study the effect of acupuncture on stump pain at 4 weeks post-amputation [ Time Frame: 4 weeks ]
- To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation [ Time Frame: 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 [ Time Frame: 4 weeks and 3 months ]
- To study the safety of acupuncture treatment in patients following amputation with phantom limb pain [ Time Frame: 4 weeks ]
Original Secondary Outcome:
- To study the effect of acupuncture on phantom limb pain at 3 months post-amputation
- To study the effect of acupuncture on stump pain at 4 weeks post-amputation
- To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation
- To study the effect of acupuncture on parameters of depression (using the Beck Depression Score) at 4 weeks and 3 months post-amputation
- To study the safety of acupuncture treatment in patients following amputation with phantom limb pain
Information By: Shaare Zedek Medical Center
Dates:
Date Received: April 12, 2007
Date Started: February 2009
Date Completion:
Last Updated: February 17, 2009
Last Verified: August 2008