Clinical trial NCT00388752: Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation
Official title: Acupuncture for Post Amputation Limb Pain: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
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
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
First posted: 2006-10-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Presence/absence of phantom limb pain (PLP) and/or residual limb pain (RLP) pre/post each treatment
measure: Level (Visual Analogue Scale [VAS]) of PLP and/or RLP pre/post each treatment
measure: Level (VAS) of PLP and/or RLP one hour post each treatment
measure: Presence/absence and level of PLP and/or RLP two weeks after final treatment
Secondary outcomes:
measure: Changes in medication regimen during treatment period and after final treatment
measure: Changes in sleep habits during treatment period and after final treatment
measure: Any change in phantom limb sensation (PLP) after final treatment
measure: Length of time for each treatment
measure: Any discomfort associated with each treatment
measure: Overall satisfaction at the end of the study
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
Study officials:
affiliation: Walter Reed Army Medical Center: Anesthesia & Operative Service, Dept of Surgery
name: Tammy J Penhollow, D.O.
role: PRINCIPAL_INVESTIGATOR
References: