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

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

Tracking Information

• First Submitted Date: October 16, 2006
• First Posted Date: October 17, 2006
• Last Update Posted Date: June 6, 2007
• Study Start Date: September 2006
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Phantom Limb
• Residual Limb Pain
• Traumatic Amputation
• Amputation

• Intervention: Procedure: Acupuncture
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 16, 2006): 21
• Original Enrollment: Same as current
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00388752
• Other Study ID Numbers: #06-20011A
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Walter Reed Army Medical Center
• Collaborators: Not Provided

Investigators

• 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