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

Amputation Clinical Trial

Official title:

Acupuncture for Post Amputation Limb Pain: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00388752
• Other study ID #: #06-20011A
• Status: Recruiting
• Phase: Phase 1
• First received: October 16, 2006
• Last updated: June 5, 2007
• Start date: September 2006

Study information

• Verified date: October 2006
• Source: Walter Reed Army Medical Center
• Contact: Tammy J Penhollow, D.O.
• Phone: 800-759-8888
• Email: tammy.penhollow[@]na.amedd.army.mil
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amputation
• Amputation, Traumatic
• Phantom Limb
• Residual Limb Pain
• Traumatic Amputation

Intervention

Procedure:
• Acupuncture

Locations

Country	Name	City	State
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/absence of phantom limb pain (PLP) and/or residual limb pain (RLP) pre/post each treatment
Primary	Level (Visual Analogue Scale [VAS]) of PLP and/or RLP pre/post each treatment
Primary	Level (VAS) of PLP and/or RLP one hour post each treatment
Primary	Presence/absence and level of PLP and/or RLP two weeks after final treatment
Secondary	Changes in medication regimen during treatment period and after final treatment
Secondary	Changes in sleep habits during treatment period and after final treatment
Secondary	Any change in phantom limb sensation (PLP) after final treatment
Secondary	Length of time for each treatment
Secondary	Any discomfort associated with each treatment
Secondary	Overall satisfaction at the end of the study