Acupuncture for Phantom Limb Pain

Phase 3

Suspended

• Conditions: Phantom Limb Pain
• Interventions: Procedure: acupuncture; Other: placebo/sham acupuncture

• Registration Number: NCT00460161
• Lead Sponsor: Shaare Zedek Medical Center

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 Description

Not available

Study Timeline

• Study First Submitted: 2007-04-12
• Study First Submitted QC: 2007-04-12
• Study First Posted: 2007-04-13
• Status Verified: 2008-08
• Study Start: 2009-02
• Last Update Submitted: 2009-02-17
• Last Update Posted: 2009-02-18
• Primary Completion: 2009-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	acupuncture	true acupuncture
2	placebo/sham acupuncture	placebo/sham acupuncture

Primary Outcome Measures

Name	Time	Method
To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation	4 weeks

Secondary Outcome Measures

Name	Time	Method
To study the effect of acupuncture on phantom limb pain at 3 months post-amputation	3 months
To study the effect of acupuncture on stump pain at 4 weeks post-amputation	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	4 weeks and 3 months
To study the safety of acupuncture treatment in patients following amputation with phantom limb pain	4 weeks
To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation	4 weeks

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel