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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acupuncture for Post Amputation Limb Pain: A Pilot Study

Conditions
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Phantom Limb, Residual Limb Pain, Traumatic Amputation, Amputation

Intervention / Treatment
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* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Acupuncture|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic, Acupuncture, Phantom limb pain, Residual limb pain, amputation, amputee, surgical, Traumatic amputation upper extremity, Traumatic amputation lower extremity, Surgical amputation upper extremity, Surgical amputation lower extremity