Recruiting
Phase 1

Acupuncture

Sponsor:

Walter Reed Army Medical Center

Code:

NCT00388752

Conditions

Phantom Limb

Residual Limb Pain

Traumatic Amputation

Amputation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acupuncture

Study Details

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

Study ID

NCT00388752

Start date

Sep, 2006

Status verified date

Oct, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

21 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Acupuncture

Primary outcome measure

  • Presence/absence of phantom limb pain (PLP) and/or residual limb pain (RLP) pre/post each treatment [ Time Frame: undefined ]
  • Level (Visual Analogue Scale [VAS]) of PLP and/or RLP pre/post each treatment [ Time Frame: undefined ]
  • Level (VAS) of PLP and/or RLP one hour post each treatment [ Time Frame: undefined ]
  • Presence/absence and level of PLP and/or RLP two weeks after final treatment [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Tammy J Penhollow, D.O.

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

Jeffrey M Gambel, M.D.

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

Locations

Walter Reed Army Medical Center

Recruiting

Washington, District of Columbia, United States, 20307-5001

Principal Investigator:

Tammy J Penhollow, D.O.

More Information

Sponsor

Walter Reed Army Medical Center

Last update posted

Jun 6, 2007

Last verified

Oct, 2006

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed Army Medical Center on 2007-06-06.