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

NCT00388752 | Unknown Phase 1

• 1 other identifier: #06-20011A
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Phantom Limb; Residual Limb Pain; Traumatic Amputation; Amputation

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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

Interventions

Acupuncture PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5001, United States

RECRUITING

MeSH Terms

Conditions

Phantom Limb; Amputation, Traumatic

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Tammy J Penhollow, D.O.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tammy J Penhollow, D.O.

CONTACT

800-759-8888; tammy.penhollow@na.amedd.army.mil

Jeffrey M Gambel, M.D.

CONTACT

202-782-6369; jeff.gambel@na.amedd.army.mil

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: October 16, 2006
• First Posted: October 17, 2006
• Study Start: September 1, 2006
• Last Updated: June 6, 2007

Record last verified: 2006-10

Locations

US (1)