Acupuncture for Phantom Limb Pain

This study has suspended participant recruitment.
(Lack of patients)
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00460161
First received: April 12, 2007
Last updated: February 17, 2009
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Phantom Limb Pain
Procedure: acupuncture
Other: placebo/sham acupuncture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Phantom Limb Pain: A Randomized, Double-Blind, Placebo/Sham - Controlled Study

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study the effect of acupuncture on phantom limb pain at 3 months post-amputation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To study the effect of acupuncture on stump pain at 4 weeks post-amputation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • To study the effect of acupuncture on parameters of depression (using the Beck Depression Score) at 4 weeks and 3 months post-amputation [ Time Frame: 4 weeks and 3 months ] [ Designated as safety issue: No ]
  • To study the safety of acupuncture treatment in patients following amputation with phantom limb pain [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: February 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00460161

Locations
Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Noah Samuels, M.D. Shaare Zedek Medical Center, Jerusalem, Israel
  More Information

No publications provided

Responsible Party: Dr. Noah Samuels, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00460161     History of Changes
Other Study ID Numbers: ACP.PLP.10.06
Study First Received: April 12, 2007
Last Updated: February 17, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Shaare Zedek Medical Center:
acupuncture
amputation
phantom limb pain

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pain

ClinicalTrials.gov processed this record on September 18, 2014