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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Walter Reed Army Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00388752
First received: October 16, 2006
Last updated: June 5, 2007
Last verified: October 2006
  Purpose

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 Intervention Phase
Phantom Limb
Residual Limb Pain
Traumatic Amputation
Amputation
Procedure: Acupuncture
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture for Post Amputation Limb Pain: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

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

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

Estimated Enrollment: 21
Study Start Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00388752     History of Changes
Other Study ID Numbers: #06-20011A
Study First Received: October 16, 2006
Last Updated: June 5, 2007
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on April 15, 2014