Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
Walter Reed Army Medical Center

Tracking Information
First Submitted Date  ICMJE October 16, 2006
First Posted Date  ICMJE October 17, 2006
Last Update Posted Date June 6, 2007
Study Start Date  ICMJE September 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2007)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2006)
  • Presence/absence of phantom limb pain (PLP) and/or residual limb pain (RLP) pre/post each treatment
  • Level (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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation
Official Title  ICMJE Acupuncture for Post Amputation Limb Pain: A Pilot Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Phantom Limb
  • Residual Limb Pain
  • Traumatic Amputation
  • Amputation
Intervention  ICMJE Procedure: Acupuncture
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 16, 2006)
21
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00388752
Other Study ID Numbers  ICMJE #06-20011A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Walter Reed Army Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tammy J Penhollow, D.O. Walter Reed Army Medical Center: Anesthesia & Operative Service, Dept of Surgery
PRS Account Walter Reed Army Medical Center
Verification Date October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP