Acupuncture for Phantom Limb Pain

Condition(s) targeted: Phantom Limb Pain

Intervention: acupuncture (Procedure); placebo/sham acupuncture (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Shaare Zedek Medical Center

Official(s) and/or principal investigator(s):
Noah Samuels, M.D., Principal Investigator, Affiliation: Shaare Zedek Medical Center, Jerusalem, Israel

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

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

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

Primary outcome: To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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:

- 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.

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

Shaare Zedek Medical Center, Jerusalem 91031, Israel; Recruiting
Noah Samuels, M.D., Phone: 972-2-6666395, Email: refplus@netvision.net.il
Jonathan Rosenblum, M.D., Phone: 972-2-6555111, Email: jrosenb@bezeqint.net

Starting date: February 2008
Last updated: August 17, 2008