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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• Procedure: acupuncture
  • 2 treatments/week for 4 weeks
• Other: placebo/sham acupuncture
  • 2 treatments/week for 4 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • true acupuncture
• Placebo Comparator: 2
  • placebo/sham acupuncture

Primary Measures

• To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• To study the effect of acupuncture on phantom limb pain at 3 months post-amputation
  • Time Frame: 3 months
    Safety Issue?: No
• To study the effect of acupuncture on stump pain at 4 weeks post-amputation
  • Time Frame: 4 weeks
    Safety Issue?: No
• To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation
  • Time Frame: 4 weeks
    Safety Issue?: No
• 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
    Safety Issue?: No
• To study the safety of acupuncture treatment in patients following amputation with phantom limb pain
  • Time Frame: 4 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Shaare Zedek Medical Center

Overall Clinical Trial Officials and Contacts

Noah Samuels, M.D. Principal Investigator Shaare Zedek Medical Center, Jerusalem, Israel  

Overall Contact: Noah Samuels, M.D. 972-2-6666395 refplus@netvision.net.il

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00460161

Study ID Number: ACP.PLP.10.06

ClinicalTrials.gov Identifier: NCT00460161

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration