Trial Outcomes & Findings for Cognitive Behavior Therapy (CBT) and Mirror Training for Phantom Limb Pain (NCT NCT00731614)
NCT ID: NCT00731614
Last Updated: 2019-10-29
Results Overview
The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.
Results posted on
2019-10-29
Participant Flow
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.
Participant milestones
| Measure |
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
|
Supportive Psychotherapy
Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
31
|
|
Overall Study
End of Treatment
|
16
|
24
|
|
Overall Study
12 Weeks Posttreatment
|
18
|
23
|
|
Overall Study
COMPLETED
|
16
|
18
|
|
Overall Study
NOT COMPLETED
|
7
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Behavior Therapy (CBT) and Mirror Training for Phantom Limb Pain
Baseline characteristics by cohort
| Measure |
Cognitive Behavior Therapy + Mirror Retraining
n=26 Participants
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
|
Supportive Psychotherapy
n=32 Participants
Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.12 years
STANDARD_DEVIATION 12.85 • n=5 Participants
|
54.62 years
STANDARD_DEVIATION 16.32 • n=7 Participants
|
57.09 years
STANDARD_DEVIATION 14.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
32 participants
n=7 Participants
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable)
Outcome measures
| Measure |
Cognitive Behavior Therapy + Mirror Retraining
n=9 Participants
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
|
Supportive Psychotherapy
n=14 Participants
Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
|
|---|---|---|
|
Phantom Limb Pain Questionnaire
Intake Pain Severity
|
6.22 units on a scale
Standard Error .82
|
5.71 units on a scale
Standard Error .66
|
|
Phantom Limb Pain Questionnaire
Session 1 Pain Severity
|
6.67 units on a scale
Standard Error .71
|
4.86 units on a scale
Standard Error .57
|
|
Phantom Limb Pain Questionnaire
Session 2 Pain Severity
|
6.00 units on a scale
Standard Error .88
|
4.71 units on a scale
Standard Error .70
|
|
Phantom Limb Pain Questionnaire
Session 3 Pain Severity
|
4.67 units on a scale
Standard Error .82
|
4.57 units on a scale
Standard Error .65
|
|
Phantom Limb Pain Questionnaire
Session 4 Pain Severity
|
4.44 units on a scale
Standard Error .93
|
4.79 units on a scale
Standard Error .75
|
|
Phantom Limb Pain Questionnaire
Session 5 Pain Severity
|
4.78 units on a scale
Standard Error .96
|
4.63 units on a scale
Standard Error .77
|
|
Phantom Limb Pain Questionnaire
Session 6 Pain Severity
|
3.33 units on a scale
Standard Error .87
|
3.57 units on a scale
Standard Error .69
|
|
Phantom Limb Pain Questionnaire
Session 7 Pain Severity
|
3.44 units on a scale
Standard Error .91
|
4.29 units on a scale
Standard Error .73
|
|
Phantom Limb Pain Questionnaire
Session 8 Pain Severity
|
4.89 units on a scale
Standard Error .84
|
3.64 units on a scale
Standard Error .68
|
|
Phantom Limb Pain Questionnaire
12 week posttreatment Pain Severity
|
4.33 units on a scale
Standard Error .93
|
3.93 units on a scale
Standard Error .75
|
|
Phantom Limb Pain Questionnaire
24 week posttreatment Pain Severity
|
4.44 units on a scale
Standard Error .93
|
4.00 units on a scale
Standard Error .74
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cognitive Behavior Therapy + Mirror Retraining
n=21 Participants
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
|
Supportive Psychotherapy
n=28 Participants
Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
|
|---|---|---|
|
Short Form-12 (SF-12)
SF12 PCS baseline
|
48.61 score on a scale
Standard Deviation 11.12
|
45.58 score on a scale
Standard Deviation 5.66
|
|
Short Form-12 (SF-12)
SF12 PCS 8 weeks (end of treatment)
|
55.47 score on a scale
Standard Deviation 10.56
|
46.31 score on a scale
Standard Deviation 7.48
|
Adverse Events
Cognitive Behavior Therapy + Mirror Retraining
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Supportive Psychotherapy
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cognitive Behavior Therapy + Mirror Retraining
n=23 participants at risk
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
|
Supportive Psychotherapy
n=31 participants at risk
Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
|
|---|---|---|
|
Renal and urinary disorders
Admission for urinary tract infection (UTI)/urosepsis
|
4.3%
1/23 • Number of events 1 • During course of treatment (8 weekly sessions).
|
0.00%
0/31 • During course of treatment (8 weekly sessions).
|
|
Vascular disorders
Peripheral arterial disease
|
4.3%
1/23 • Number of events 1 • During course of treatment (8 weekly sessions).
|
0.00%
0/31 • During course of treatment (8 weekly sessions).
|
|
Musculoskeletal and connective tissue disorders
Fall/ broken femur
|
0.00%
0/23 • During course of treatment (8 weekly sessions).
|
3.2%
1/31 • Number of events 1 • During course of treatment (8 weekly sessions).
|
|
Vascular disorders
Stroke
|
0.00%
0/23 • During course of treatment (8 weekly sessions).
|
3.2%
1/31 • Number of events 1 • During course of treatment (8 weekly sessions).
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/23 • During course of treatment (8 weekly sessions).
|
3.2%
1/31 • Number of events 1 • During course of treatment (8 weekly sessions).
|
Other adverse events
| Measure |
Cognitive Behavior Therapy + Mirror Retraining
n=23 participants at risk
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
|
Supportive Psychotherapy
n=31 participants at risk
Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
|
|---|---|---|
|
General disorders
Pain exacerbation
|
4.3%
1/23 • Number of events 1 • During course of treatment (8 weekly sessions).
|
0.00%
0/31 • During course of treatment (8 weekly sessions).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place