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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00731614 |
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 |
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Phantom Limb |
Behavioral: Cognitive Behavioral Therapy and Mirror Retraining Behavioral: Supportive therapy Behavioral: Mirror retraining |
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 |
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 |
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1: Experimental
Cognitive Behavior Therapy + mirror retraining
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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
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2: Active Comparator
Supportive psychotherapy
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Behavioral: Supportive therapy
Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
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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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | John R. McQuaid, PhD MS BA | VA San Diego Healthcare System, San Diego |
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 |
cognitive therapy mirror training nondirective therapy veterans amputees |
Signs and Symptoms Neurologic Manifestations Pain |
Phantom Limb Neurobehavioral Manifestations Perceptual Disorders |
Nervous System Diseases |