Cognitive Behavior Therapy (CBT) and Mirror Training for Phantom Limb Pain
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|ClinicalTrials.gov Identifier: NCT00731614|
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : June 18, 2015
Last Update Posted : June 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Phantom Limb||Behavioral: Cognitive Behavioral Therapy and Mirror Retraining Behavioral: Supportive therapy Behavioral: Mirror retraining||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Psychosocial and Visual Feedback Intervention for Phantom Limb Pain|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||December 2012|
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
Behavioral: Supportive therapy
Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
Other Name: Non-directive therapy
- 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)
- SF-12 [ Time Frame: Baseline, end of treatment, 12 weeks posttreatment, 24 weeks posttreatment ]the SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731614
|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|
|Principal Investigator:||John R. McQuaid, PhD MS BA||VA Medical Center, San Francisco|