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

Phase 1

• Conditions: Phantom Limb; Residual Limb Pain; Traumatic Amputation; Amputation

• Registration Number: NCT00388752
• Lead Sponsor: Walter Reed Army Medical Center

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 Timeline

• Study Start: 2006-09
• Status Verified: 2006-10
• Study First Submitted: 2006-10-16
• Study First Submitted QC: 2006-10-16
• Study First Posted: 2006-10-17
• Last Update Submitted: 2007-06-05
• Last Update Posted: 2007-06-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States