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

Tracking Information

First Received Date ^ICMJE

October 16, 2006

Last Updated Date

June 5, 2007

Start Date ^ICMJE

September 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Same as current

Change History

Complete list of historical versions of study NCT00388752 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Phantom Limb
Residual Limb Pain
Traumatic Amputation
Amputation

Intervention ^ICMJE

Procedure: Acupuncture

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Tammy J Penhollow, D.O.	800-759-8888 ext 146-9290	tammy.penhollow@na.amedd.army.mil
Contact: Jeffrey M Gambel, M.D.	202-782-6369	jeff.gambel@na.amedd.army.mil

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00388752

Responsible Party

Study ID Numbers ^ICMJE

#06-20011A

Study Sponsor ^ICMJE

Walter Reed Army Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Tammy J Penhollow, D.O.

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

Information Provided By

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