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Cognitive Behavior Therapy (CBT) and Mirror Training for Phantom Limb Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00731614
First received: August 5, 2008
Last updated: October 24, 2014
Last verified: October 2014
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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 Questionnaire [ 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-12 [ Time Frame: Baseline, end of treatment, 12 weeks posttreatment, 24 weeks posttreatment ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: November 2008
Study Completion Date: December 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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
Other Name: Mirror box training
Active Comparator: Arm 2
Supportive psychotherapy
Behavioral: Supportive therapy
Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
Other Name: Non-directive therapy

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 (21or over)
  • unilateral amputation at or above wrist or ankle
  • phantom limb pain occurring at least weekly
  • living within 50 miles of VASDHS
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731614

Locations
United States, California
VA Medical Center, Long Beach
Long Beach, California, United States, 90822
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
VA Medical Center, San Francisco
San Francisco, California, United States, 94121
Sponsors and Collaborators
Investigators
Principal Investigator: John R. McQuaid, PhD MS BA VA Medical Center, San Francisco
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00731614     History of Changes
Other Study ID Numbers: F6441-R, UCSD IRB 080898
Study First Received: August 5, 2008
Last Updated: October 24, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Phantom Limb
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pain
Pain, Postoperative
Pathologic Processes
Perceptual Disorders
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014