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

Purpose

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.

Condition	Intervention	Phase
Phantom Limb Residual Limb Pain Traumatic Amputation Amputation	Procedure: Acupuncture	Phase I

MedlinePlus related topics:

Acupuncture Amputees

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	21
Study Start Date:	September 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388752

Contacts


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

Locations


United States, District of Columbia
	Walter Reed Army Medical Center	Recruiting
	Washington, District of Columbia, United States, 20307-5001
	Principal Investigator: Tammy J Penhollow, D.O.

Sponsors and Collaborators

Walter Reed Army Medical Center

Investigators


Principal Investigator:	Tammy J Penhollow, D.O.	Walter Reed Army Medical Center: Anesthesia & Operative Service, Dept of Surgery

More Information

Study ID Numbers:	#06-20011A
First Received:	October 16, 2006
Last Updated:	June 5, 2007
ClinicalTrials.gov Identifier:	NCT00388752
Health Authority:	United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:

Acupuncture

Phantom limb pain

Residual limb pain

amputation

amputee

traumatic

surgical

Traumatic amputation upper extremity

Traumatic amputation lower extremity

Surgical amputation upper extremity

Surgical amputation lower extremity

Study placed in the following topic categories:

Signs and Symptoms

Wounds and Injuries

Neurologic Manifestations

Disorders of Environmental Origin

Pain

Phantom Limb

Neurobehavioral Manifestations

Perceptual Disorders

Amputation, Traumatic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	Walter Reed Army Medical Center
Information provided by:	Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00388752