Acupuncture for Phantom Limb Pain

NCT00460161 | Suspended Phase 3

• 1 other identifier: ACP.PLP.10.06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Phantom Limb Pain

Keywords

acupuncture; amputation; phantom limb pain

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

true acupuncture

Procedure: acupuncture

2

PLACEBO COMPARATOR

placebo/sham acupuncture

Other: placebo/sham acupuncture

Interventions

acupuncture PROCEDURE

2 treatments/week for 4 weeks

1

placebo/sham acupuncture OTHER

2 treatments/week for 4 weeks

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Phantom Limb

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Noah Samuels, M.D.

  Shaare Zedek Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 12, 2007
• First Posted: April 13, 2007
• Study Start: February 1, 2009
• Primary Completion: August 1, 2009
• Last Updated: February 18, 2009

Record last verified: 2008-08

Locations

IL (1)