Phantom Limb
Conditions
Keywords
cognitive therapy, mirror training, nondirective therapy, veterans, amputees
Brief summary
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.
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 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.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALSupportive therapy
Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
BEHAVIORALMirror 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
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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 a recruitment site (San Diego, San Francisco, or Long Beach VAs). * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phantom Limb Pain Questionnaire | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form-12 (SF-12) | Baseline, end of treatment (8 weeks after baseline) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| Supportive Psychotherapy Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions. | 32 |
| Total | 58 |
Baseline characteristics
| Characteristic | Cognitive Behavior Therapy + Mirror Retraining | Total | Supportive Psychotherapy |
|---|---|---|---|
| Age, Continuous | 60.12 years STANDARD_DEVIATION 12.85 | 57.09 years STANDARD_DEVIATION 14.99 | 54.62 years STANDARD_DEVIATION 16.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 10 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 39 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) White | 18 Participants | 41 Participants | 23 Participants |
| Region of Enrollment United States | 26 participants | 58 participants | 32 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 23 Participants | 53 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 23 | 0 / 31 |
| serious Total, serious adverse events | 2 / 23 | 3 / 31 |
Outcome results
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)
Time frame: Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.
Population: Data analyzed for participants with complete data for all assessments using repeated measure ANOVA.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavior Therapy + Mirror Retraining | Phantom Limb Pain Questionnaire | Session 3 Pain Severity | 4.67 units on a scale | Standard Error 0.82 |
| Cognitive Behavior Therapy + Mirror Retraining | Phantom Limb Pain Questionnaire | Session 6 Pain Severity | 3.33 units on a scale | Standard Error 0.87 |
| Cognitive Behavior Therapy + Mirror Retraining | Phantom Limb Pain Questionnaire | Session 2 Pain Severity | 6.00 units on a scale | Standard Error 0.88 |
| Cognitive Behavior Therapy + Mirror Retraining | Phantom Limb Pain Questionnaire | Session 7 Pain Severity | 3.44 units on a scale | Standard Error 0.91 |
| Cognitive Behavior Therapy + Mirror Retraining | Phantom Limb Pain Questionnaire | Session 4 Pain Severity | 4.44 units on a scale | Standard Error 0.93 |
| Cognitive Behavior Therapy + Mirror Retraining | Phantom Limb Pain Questionnaire | Session 8 Pain Severity | 4.89 units on a scale | Standard Error 0.84 |
| Cognitive Behavior Therapy + Mirror Retraining | Phantom Limb Pain Questionnaire | Session 1 Pain Severity | 6.67 units on a scale | Standard Error 0.71 |
| Cognitive Behavior Therapy + Mirror Retraining | Phantom Limb Pain Questionnaire | 12 week posttreatment Pain Severity | 4.33 units on a scale | Standard Error 0.93 |
| Cognitive Behavior Therapy + Mirror Retraining | Phantom Limb Pain Questionnaire | Session 5 Pain Severity | 4.78 units on a scale | Standard Error 0.96 |
| Cognitive Behavior Therapy + Mirror Retraining | Phantom Limb Pain Questionnaire | 24 week posttreatment Pain Severity | 4.44 units on a scale | Standard Error 0.93 |
| Cognitive Behavior Therapy + Mirror Retraining | Phantom Limb Pain Questionnaire | Intake Pain Severity | 6.22 units on a scale | Standard Error 0.82 |
| Supportive Psychotherapy | Phantom Limb Pain Questionnaire | 24 week posttreatment Pain Severity | 4.00 units on a scale | Standard Error 0.74 |
| Supportive Psychotherapy | Phantom Limb Pain Questionnaire | Intake Pain Severity | 5.71 units on a scale | Standard Error 0.66 |
| Supportive Psychotherapy | Phantom Limb Pain Questionnaire | Session 1 Pain Severity | 4.86 units on a scale | Standard Error 0.57 |
| Supportive Psychotherapy | Phantom Limb Pain Questionnaire | Session 2 Pain Severity | 4.71 units on a scale | Standard Error 0.7 |
| Supportive Psychotherapy | Phantom Limb Pain Questionnaire | Session 3 Pain Severity | 4.57 units on a scale | Standard Error 0.65 |
| Supportive Psychotherapy | Phantom Limb Pain Questionnaire | Session 4 Pain Severity | 4.79 units on a scale | Standard Error 0.75 |
| Supportive Psychotherapy | Phantom Limb Pain Questionnaire | Session 5 Pain Severity | 4.63 units on a scale | Standard Error 0.77 |
| Supportive Psychotherapy | Phantom Limb Pain Questionnaire | Session 6 Pain Severity | 3.57 units on a scale | Standard Error 0.69 |
| Supportive Psychotherapy | Phantom Limb Pain Questionnaire | Session 7 Pain Severity | 4.29 units on a scale | Standard Error 0.73 |
| Supportive Psychotherapy | Phantom Limb Pain Questionnaire | Session 8 Pain Severity | 3.64 units on a scale | Standard Error 0.68 |
| Supportive Psychotherapy | Phantom Limb Pain Questionnaire | 12 week posttreatment Pain Severity | 3.93 units on a scale | Standard Error 0.75 |
Comparison: Conducted a repeated measures ANOVA comparing CBT+mirror retraining with Supportive Therapy across 11 time points. The primary hypothesis was a group by time interaction. Due to missing data, a total of 9 and 14 participants, respectively could be included in analyses.p-value: 0.322Repeated Measure ANOVA
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.
Time frame: Baseline, end of treatment (8 weeks after baseline)
Population: While a total of 49 participants completed the trial, missing data reduced the number in each condition for some analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavior Therapy + Mirror Retraining | Short Form-12 (SF-12) | SF12 PCS baseline | 48.61 score on a scale | Standard Deviation 11.12 |
| Cognitive Behavior Therapy + Mirror Retraining | Short Form-12 (SF-12) | SF12 PCS 8 weeks (end of treatment) | 55.47 score on a scale | Standard Deviation 10.56 |
| Supportive Psychotherapy | Short Form-12 (SF-12) | SF12 PCS baseline | 45.58 score on a scale | Standard Deviation 5.66 |
| Supportive Psychotherapy | Short Form-12 (SF-12) | SF12 PCS 8 weeks (end of treatment) | 46.31 score on a scale | Standard Deviation 7.48 |