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

Primary Purpose

Phantom Limb, Residual Limb Pain, Traumatic Amputation

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Walter Reed Army Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phantom Limb focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Walter Reed Army Medical CenterRecruiting

Outcomes

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

Full Information

First Posted
October 16, 2006
Last Updated
June 5, 2007
Sponsor
Walter Reed Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00388752
Brief Title
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

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Walter Reed Army Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Primary Outcome Measure Information:
Title
Presence/absence of phantom limb pain (PLP) and/or residual limb pain (RLP) pre/post each treatment
Title
Level (Visual Analogue Scale [VAS]) of PLP and/or RLP pre/post each treatment
Title
Level (VAS) of PLP and/or RLP one hour post each treatment
Title
Presence/absence and level of PLP and/or RLP two weeks after final treatment
Secondary Outcome Measure Information:
Title
Changes in medication regimen during treatment period and after final treatment
Title
Changes in sleep habits during treatment period and after final treatment
Title
Any change in phantom limb sensation (PLP) after final treatment
Title
Length of time for each treatment
Title
Any discomfort associated with each treatment
Title
Overall satisfaction at the end of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tammy J Penhollow, D.O.
Phone
800-759-8888
Ext
146-9290
Email
tammy.penhollow@na.amedd.army.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey M Gambel, M.D.
Phone
202-782-6369
Email
jeff.gambel@na.amedd.army.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammy J Penhollow, D.O.
Organizational Affiliation
Walter Reed Army Medical Center: Anesthesia & Operative Service, Dept of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammy J Penhollow, D.O.

12. IPD Sharing Statement

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

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