Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Cognitive Behavior Therapy (CBT) and Mirror Training for Phantom Limb Pain
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, December 2008
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00731614
  Purpose

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.


Condition Intervention
Phantom Limb
Behavioral: Cognitive Behavioral Therapy and Mirror Retraining
Behavioral: Supportive therapy
Behavioral: Mirror retraining

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Psychosocial and Visual Feedback Intervention for Phantom Limb Pain

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Phantom Limb Pain Questionaire [ Time Frame: Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-36 [ Time Frame: Baseline, end of treatment, 12 weeks posttreatment, 24 weeks posttreatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Cognitive Behavior Therapy + mirror retraining
Behavioral: Cognitive Behavioral Therapy and Mirror Retraining
Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.
Behavioral: Mirror retraining
Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain
2: Active Comparator
Supportive psychotherapy
Behavioral: Supportive therapy
Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.

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 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 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (21 or over)
  • Unilateral amputation at or above wrist or ankle
  • Phantom limb pain occuring at least weekly
  • Enrolled at VASDHS and living within 50 miles of VASDHS
  • Able to read ans speak English

Exclusion Criteria:

  • Current alcohol or drug dependence
  • Active psychosis
  • Medical problems that preclude participation
  • Current enrollment in behavioral pain management
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731614

Contacts
Contact: Deborah Velez, NP (858) 552-8585 ext 2781 deborah.velez@va.gov
Contact: Kathleen Parkes, BS (858) 552-8585 ext 6495 kathleen.parkes@gmail.com

Locations
United States, California
VA San Diego Healthcare System, San Diego Recruiting
San Diego, California, United States, 92161
Contact: Janet M Peyton, MA MA     858-642-3657     janet.peyton@va.gov    
Principal Investigator: John R. McQuaid, PhD MS BA            
Sponsors and Collaborators
Investigators
Principal Investigator: John R. McQuaid, PhD MS BA VA San Diego Healthcare System, San Diego
  More Information

Responsible Party: Department of Veterans Affairs ( McQuaid, John - Principal Investigator )
Study ID Numbers: F6441R, UCSD IRB 080898
Study First Received: August 5, 2008
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00731614  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
cognitive therapy
mirror training
nondirective therapy
veterans
amputees

Study placed in the following topic categories:
Signs and Symptoms
Neurologic Manifestations
Pain
Phantom Limb
Neurobehavioral Manifestations
Perceptual Disorders

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009