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Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation

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.
ClinicalTrials.gov Identifier: NCT00388752
Recruitment Status : Unknown
Verified October 2006 by Walter Reed Army Medical Center.
Recruitment status was:  Recruiting
First Posted : October 17, 2006
Last Update Posted : June 6, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to identify the best treatment sequence and combination of acupuncture points for the treatment of phantom limb or residual limb pain in the traumatic/surgical amputee.

Condition or disease Intervention/treatment Phase
Phantom Limb Residual Limb Pain Traumatic Amputation Amputation Procedure: Acupuncture Phase 1

Detailed Description:

The purpose of this pilot study is to identify the optimum combination of acupuncture points and treatment sequence in the treatment of post amputation limb pain in terms of the change in Phantom Limb Pain (PLP) and/or Residual Limb Pain (RLP) as measured by the Visual Analogue Scale (VAS) and the McGill Short Form Pain Questionnaire (SF-MPQ). Further, any side effects associated with the acupuncture treatment regimens, time requirements, and patient compliance with the treatment regimens will be estimated.

Study participants will be randomized to one of three acupuncture treatments: Chinese Scalp Acupuncture, French Auricular Acupuncture, or a combination of both.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture for Post Amputation Limb Pain: A Pilot Study
Study Start Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Presence/absence of phantom limb pain (PLP) and/or residual limb pain (RLP) pre/post each treatment
  2. Level (Visual Analogue Scale [VAS]) of PLP and/or RLP pre/post each treatment
  3. Level (VAS) of PLP and/or RLP one hour post each treatment
  4. Presence/absence and level of PLP and/or RLP two weeks after final treatment

Secondary Outcome Measures :
  1. Changes in medication regimen during treatment period and after final treatment
  2. Changes in sleep habits during treatment period and after final treatment
  3. Any change in phantom limb sensation (PLP) after final treatment
  4. Length of time for each treatment
  5. Any discomfort associated with each treatment
  6. Overall satisfaction at the end of the study

Eligibility Criteria

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:

  • Amputees with traumatic/surgical amputation of a limb (greater than fingers or toes) secondary to trauma or peripheral vascular disease
  • Amputees who have been cleared to begin prosthetic fitting
  • Phantom and/or residual limb pain reported must be >/= 3/10
  • Active duty military or dependent eligible for military benefit >/=18 years old

Exclusion Criteria:

  • Congenital limb absence
  • Pregnancy
  • Any skin changes on the ear or scalp that would preclude placement of acupuncture needles
  • Patients intubated and unable to give consent
  • Patients with traumatic brain injury (TBI) diagnosed as greater than mild
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): NCT00388752


Contacts
Contact: Tammy J Penhollow, D.O. 800-759-8888 ext 146-9290 tammy.penhollow@na.amedd.army.mil
Contact: Jeffrey M Gambel, M.D. 202-782-6369 jeff.gambel@na.amedd.army.mil

Locations
United States, District of Columbia
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307-5001
Principal Investigator: Tammy J Penhollow, D.O.         
Sponsors and Collaborators
Walter Reed Army Medical Center
Investigators
Principal Investigator: Tammy J Penhollow, D.O. Walter Reed Army Medical Center: Anesthesia & Operative Service, Dept of Surgery
More Information

ClinicalTrials.gov Identifier: NCT00388752     History of Changes
Other Study ID Numbers: #06-20011A
First Posted: October 17, 2006    Key Record Dates
Last Update Posted: June 6, 2007
Last Verified: October 2006

Keywords provided by Walter Reed Army Medical Center:
Acupuncture
Phantom limb pain
Residual limb pain
amputation
amputee
traumatic
surgical
Traumatic amputation upper extremity
Traumatic amputation lower extremity
Surgical amputation upper extremity
Surgical amputation lower extremity

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