Trial record 4 of 10 for:
Open Studies | "Amputation, Traumatic"
Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Walter Reed Army Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Walter Reed Army Medical Center
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00388752
First received: October 16, 2006
Last updated: June 5, 2007
Last verified: October 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Phantom Limb Residual Limb Pain Traumatic Amputation Amputation |
Procedure: Acupuncture |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Acupuncture for Post Amputation Limb Pain: A Pilot Study |
Resource links provided by NLM:
Further study details as provided by Walter Reed Army Medical Center:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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
- Overall satisfaction at the end of the study
| Estimated Enrollment: | 21 |
| Study Start Date: | September 2006 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388752
Contacts
| Contact: Tammy J Penhollow, D.O. | 800-759-8888 ext 146-9290 | tammy.penhollow@na.amedd.army.mil |
| Contact: Jeffrey M Gambel, M.D. | 202-782-6369 | jeff.gambel@na.amedd.army.mil |
Locations
| United States, District of Columbia | |
| Walter Reed Army Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20307-5001 | |
| Principal Investigator: Tammy J Penhollow, D.O. | |
Sponsors and Collaborators
Walter Reed Army Medical Center
Investigators
| Principal Investigator: | Tammy J Penhollow, D.O. | Walter Reed Army Medical Center: Anesthesia & Operative Service, Dept of Surgery |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00388752 History of Changes |
| Other Study ID Numbers: | #06-20011A |
| Study First Received: | October 16, 2006 |
| Last Updated: | June 5, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by Walter Reed Army Medical Center:
|
Traumatic amputation upper extremity Traumatic amputation lower extremity Acupuncture Phantom limb pain Residual limb pain amputation |
amputee traumatic surgical Surgical amputation upper extremity Surgical amputation lower extremity |
Additional relevant MeSH terms:
|
Amputation, Traumatic Phantom Limb Wounds and Injuries Perceptual Disorders |
Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013