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Acupuncture for Phantom Limb Pain

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. Identifier: NCT00460161
Recruitment Status : Suspended (Lack of patients)
First Posted : April 13, 2007
Last Update Posted : February 18, 2009
Information provided by:
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : February 2009
Estimated Primary Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

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

Primary Outcome Measures :
  1. To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation [ Time Frame: 4 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00460161

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

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Responsible Party: Dr. Noah Samuels, Shaare Zedek Medical Center Identifier: NCT00460161    
Other Study ID Numbers: ACP.PLP.10.06
First Posted: April 13, 2007    Key Record Dates
Last Update Posted: February 18, 2009
Last Verified: August 2008
Keywords provided by Shaare Zedek Medical Center:
phantom limb pain
Additional relevant MeSH terms:
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Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Signs and Symptoms