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Acupuncture for Phantom Limb Pain

This study has suspended participant recruitment.
(Lack of patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00460161
First Posted: April 13, 2007
Last Update Posted: February 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shaare Zedek Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • To study the effect of acupuncture on phantom limb pain at 3 months post-amputation [ Time Frame: 3 months ]
  • To study the effect of acupuncture on stump pain at 4 weeks post-amputation [ Time Frame: 4 weeks ]
  • To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation [ Time Frame: 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 [ Time Frame: 4 weeks and 3 months ]
  • To study the safety of acupuncture treatment in patients following amputation with phantom limb pain [ Time Frame: 4 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Noah Samuels, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00460161     History of Changes
Other Study ID Numbers: ACP.PLP.10.06
First Submitted: April 12, 2007
First Posted: April 13, 2007
Last Update Posted: February 18, 2009
Last Verified: August 2008

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
Pain
Postoperative Complications
Pathologic Processes
Signs and Symptoms