Amputation, Phantom Limb, Residual Limb Pain, Traumatic Amputation
Conditions
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
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.
Interventions
PROCEDUREAcupuncture
Sponsors
Walter Reed Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Any discomfort associated with each treatment | — |
| Changes in medication regimen during treatment period and after final treatment | — |
| Overall satisfaction at the end of the study | — |
| 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 | — |
Countries
United States
Contacts
Primary ContactTammy J Penhollow, D.O.
Backup ContactJeffrey M Gambel, M.D.
Outcome results
None listed