Acupuncture for Phantom Limb Pain

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 Overview

• Status: Suspended
• Conditions: Phantom Limb Pain
• Intervention / Treatment: Procedure: acupuncture; Other: placebo/sham acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; true acupuncture	Procedure: acupuncture; 2 treatments/week for 4 weeks
Placebo Comparator: 2; placebo/sham acupuncture	Other: placebo/sham acupuncture; 2 treatments/week for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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 analgesic use (Tramadol 100mg) during the first 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

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Principal Investigator: Noah Samuels, M.D., Shaare Zedek Medical Center, Jerusalem, Israel

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Anticipated): August 1, 2009

Study Registration Dates

• First Submitted: April 12, 2007
• First Submitted That Met QC Criteria: April 12, 2007
• First Posted (Estimate): April 13, 2007

Study Record Updates

• Last Update Posted (Estimate): February 18, 2009
• Last Update Submitted That Met QC Criteria: February 17, 2009
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: acupuncture; amputation; phantom limb pain
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Phantom Limb
• Other Study ID Numbers: ACP.PLP.10.06