Skip to main content
Clinical Trials/NCT00731614
NCT00731614
Completed
N/A

Psychosocial and Visual Feedback Intervention for Phantom Limb Pain

VA Office of Research and Development3 sites in 1 country59 target enrollmentNovember 2008
ConditionsPhantom Limb

Overview

Phase
N/A
Intervention
Not specified
Conditions
Phantom Limb
Sponsor
VA Office of Research and Development
Enrollment
59
Locations
3
Primary Endpoint
Phantom Limb Pain Questionnaire
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The goal of this study is to test whether a combination of cognitive-behavior therapy and mirror training reduces phantom limb pain for veterans with amputations.

Detailed Description

The proposed study is a randomized controlled trial designed to test whether CBT plus mirror therapy (CBT+MT) is superior to supportive care (SC) for treatment of phantom limb pain (PLP) in amputees. The primary hypothesis is that CBT+ MT will lead to significantly greater reductions in PLP compared to SC. Secondary hypotheses will test whether CBT+MT also leads to significantly greater improvements in psychiatric symptoms, functioning, and quality of life than SC. Eighty veterans from the San Diego VA Healthcare System (SDVAHS) will be recruited. All veterans will have a unilateral upper or lower limb amputation. All participants will complete an intake assessment prior to treatment randomization. The assessment will include measures of pain (Phantom Limb Pain Questionnaire, Descriptive Differential Scale, McGill Pain Questionnaire) psychiatric symptoms (Patient Health Questionnaire, Posttraumatic Stress disorder Checklist), psychiatric diagnosis (Mini-International Neuropsychiatric Interview) and functioning (Trinity Amputation and Prosthesis Experiences Scale, Short Form-36). Participants will then randomized to either CBT+MT or SC. Participants will complete pain and mood assessments weekly during treatment, and be retested on the full assessment battery at the end of treatment and 12 and 24 weeks posttreatment. The CBT+MT intervention will consist of 8 individual sessions of CBT, including psychoeducation, cognitive restructuring, relaxation training, and acceptance techniques. Participants in the CBT+MT condition will also learn to use a mirror apparatus to reduce PLP, and will receive a set of mirrors to use at home. The SC treatment will consist of the therapist meeting with the patient and using listening and reflection skills to discuss the patient's pain. The SC condition will have no pain education or skills training component. Data analyses will use a repeated-measures ANOVA approach to test whether the two conditions differ on change in the primary measure (Phantom Limb Pain Questionnaire) as well as in other pain, psychiatric symptom, functioning and quality of life measures. Exploratory analyses will test whether patient variables and amputation characteristics predict treatment outcomes.

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
December 2012
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult (21or over)
  • unilateral amputation at or above wrist or ankle
  • phantom limb pain occurring at least weekly
  • living within 50 miles of a recruitment site (San Diego, San Francisco, or Long Beach VAs).
  • able to read and speak English

Exclusion Criteria

  • Current alcohol or drug dependence
  • active psychosis
  • medical problems that preclude participation
  • current enrollment in behavioral pain management

Outcomes

Primary Outcomes

Phantom Limb Pain Questionnaire

Time Frame: Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.

The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable)

Secondary Outcomes

  • Short Form-12 (SF-12)(Baseline, end of treatment (8 weeks after baseline))

Study Sites (3)

Loading locations...

Similar Trials