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| ID | Type | Description | Link |
|---|---|---|---|
| UCSD IRB 080898 | Other Identifier | UCSD IRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Cognitive Behavior Therapy + mirror retraining |
|
| Arm 2 | Active Comparator | Supportive psychotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy and Mirror Retraining | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Phantom Limb Pain Questionnaire | The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable) | Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form-12 (SF-12) | the Short Form-12 (SF-12) is a standardized self-report questionnaire that assesses mental and physical functioning. The Physical Component Summary (PCS) is scored on a scale from 0-100, with higher scores representing better reported health. | Baseline, end of treatment (8 weeks after baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John R. McQuaid, PhD MS BA | VA Medical Center, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Long Beach | Long Beach | California | 90822 | United States | ||
| VA San Diego Healthcare System, San Diego |
While 59 participant initially enrolled, 1 completed no assessments, so the overall n= 58. In addition, 4 did not complete the first week assessment session, which is why patient flow ends up listing 54 at the start rather than 58.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavior Therapy + Mirror Retraining | 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. 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 |
| FG001 | Supportive Psychotherapy | Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants are adults with a single limb amputation who report current phantom limb pain.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavior Therapy + Mirror Retraining | 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. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phantom Limb Pain Questionnaire | The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable) | Data analyzed for participants with complete data for all assessments using repeated measure ANOVA. | Posted | Mean | Standard Error | units on a scale | Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment. |
|
During course of treatment (8 weekly sessions).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Behavior Therapy + Mirror Retraining | 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. 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Admission for urinary tract infection (UTI)/urosepsis | Renal and urinary disorders | Non-systematic Assessment | Participant had a history of chronic renal disease secondary to diabetes prior to study entry, s/p renal transplant, experienced UTI and was admitted for treatment. Symptoms were deemed unrelated to study intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain exacerbation | General disorders | Non-systematic Assessment | Participant reported increase in pain while using visual feedback for treatment of phantom limb pain. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John R. McQuaid, Ph.D. | San Francisco VA Medical Center | 415-221-4810 | 4106 | john.mcquaid@va.gov |
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| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D005791 | Patient Care |
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| Supportive therapy | Behavioral | Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions. |
|
|
| Mirror retraining | Behavioral | 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 |
|
|
| San Diego |
| California |
| 92161 |
| United States |
| VA Medical Center, San Francisco | San Francisco | California | 94121 | United States |
| BG001 | Supportive Psychotherapy | Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Supportive Psychotherapy | Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions. |
|
|
|
| Secondary | Short Form-12 (SF-12) | the Short Form-12 (SF-12) is a standardized self-report questionnaire that assesses mental and physical functioning. The Physical Component Summary (PCS) is scored on a scale from 0-100, with higher scores representing better reported health. | While a total of 49 participants completed the trial, missing data reduced the number in each condition for some analyses. | Posted | Mean | Standard Deviation | score on a scale | Baseline, end of treatment (8 weeks after baseline) |
|
|
|
| 2 |
| 23 |
| 1 |
| 23 |
| EG001 | Supportive Psychotherapy | Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions. | 3 | 31 | 0 | 31 |
|
| Peripheral arterial disease | Vascular disorders | Non-systematic Assessment | Participant withdrew from study due to deteriorating health (peripheral arterial disease). Disease progression was unrelated to study procedures. |
|
| Fall/ broken femur | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Pt fell and broke femur, requiring hospitalization and withdrawal from study. Fall was unrelated to study procedures. |
|
| Stroke | Vascular disorders | Non-systematic Assessment | Participant had stroke while driving, necessitating withdrawal from study. Stroke was unrelated to the study procedures. |
|
| Congestive Heart Failure | Cardiac disorders | Non-systematic Assessment | Participant admitted to hospital for exacerbation of congestive heart failure due to upper respiratory infection. Hospitalization unrelated to study procedures. |
|
|
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| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010146 | Pain |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| SF12 PCS 8 weeks (end of treatment) |
|
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