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

NCT ID: NCT00388752

Last Updated: 2007-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

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.

Conditions

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Phantom Limb Residual Limb Pain Traumatic Amputation Amputation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Acupuncture

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Walter Reed Army Medical Center

FED

Sponsor Role lead

Principal Investigators

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Tammy J Penhollow, D.O.

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Medical Center: Anesthesia & Operative Service, Dept of Surgery

Locations

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Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tammy J Penhollow, D.O.

Role: CONTACT

[email protected]
800-759-8888 ext. 146-9290

Jeffrey M Gambel, M.D.

Role: CONTACT

[email protected]
202-782-6369

Other Identifiers

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#06-20011A

Identifier Type: -

Identifier Source: org_study_id