Acupuncture for Phantom Limb Pain

Shaare Zedek Medical Center

Status and phase

Suspended

Phase 3

Conditions

Phantom Limb Pain

Treatments

Procedure: acupuncture

Other: placebo/sham acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT00460161

ACP.PLP.10.06

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.