Trial Outcomes & Findings for Internet-based Behavioral Pain Management (NCT NCT01918189)
NCT ID: NCT01918189
Last Updated: 2019-11-18
Results Overview
Self-report measure of pain-related functional interference. The 9-item Interference subscale, scores ranging from 0-6, of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI)-Interference scale assesses pain-related interference. Lower scores indicate less pain-related interference (i.e., better outcome). A reduction in WHYMPI-Interference Scale scores of 0.6 or greater has been identified as an indicator of meaningful improvement in physical functioning. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value).
COMPLETED
NA
59 participants
baseline and 10 weeks post-baseline
2019-11-18
Participant Flow
Participant enrollment began July 1, 2014 and last data collection for primary outcome was October 31, 2018. Recruitment target of 58 participants was met. 59 participants enrolled in the study (i.e., signed informed consent) but 58 completed baseline measures and were included in outcomes analyses.
Participant milestones
| Measure |
10 Week Pain EASE Access
behavioral pain self-management intervention (Pain EASE) delivered via the Internet
behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
Completed Baseline Assessment
|
58
|
|
Overall Study
Completed Follow-up Assessment
|
41
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Internet-based Behavioral Pain Management
Baseline characteristics by cohort
| Measure |
10 Week Pain EASE Access
n=58 Participants
behavioral pain self-management intervention (Pain EASE) delivered via the Internet
behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 Participants
n=5 Participants
|
|
Multidimensional Pain Inventory Interference Subscale
|
3.82 units on a scale
STANDARD_DEVIATION 0.19 • n=5 Participants
|
|
Pain Intensity Numeric Rating Scale
|
5.91 units on a scale
STANDARD_DEVIATION 0.25 • n=5 Participants
|
|
Profile of Mood States
|
49.53 units on a scale
STANDARD_DEVIATION 5.62 • n=5 Participants
|
|
Multidimensional Fatigue Inventory
|
14.05 units on a scale
STANDARD_DEVIATION 0.52 • n=5 Participants
|
|
Medical Outcomes Study Sleep Scale
|
50.09 units on a scale
STANDARD_DEVIATION 3.80 • n=5 Participants
|
|
Beck Depression Inventory
|
15.47 units on a scale
STANDARD_DEVIATION 1.37 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 10 weeks post-baselinePopulation: 17 of the 58 participants who completed baseline did not complete 10-week post-baseline assessment (study endpoint)
Self-report measure of pain-related functional interference. The 9-item Interference subscale, scores ranging from 0-6, of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI)-Interference scale assesses pain-related interference. Lower scores indicate less pain-related interference (i.e., better outcome). A reduction in WHYMPI-Interference Scale scores of 0.6 or greater has been identified as an indicator of meaningful improvement in physical functioning. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value).
Outcome measures
| Measure |
10 Week Pain EASE Access
n=41 Participants
behavioral pain self-management intervention (Pain EASE) delivered via the Internet
behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing
|
|---|---|
|
Multidimensional Pain Inventory Interference Subscale
|
0.53 score on a scale
Interval 0.15 to 0.92
|
SECONDARY outcome
Timeframe: baseline and 10 weeks post-baselineself-report measure of pain intensity measured on a 0-10 likert scale. Participants are asked, "Please rate your pain by indicating the number that best describes your average pain over the past week on a 0 (no pain) to 10 (pain as bad as you can imagine) scale". Scores of 1-3 reflect mild pain, 4-6 moderate pain, and 7-10 severe pain. Lower scores reflect less pain, and therefore, better outcome. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value).
Outcome measures
| Measure |
10 Week Pain EASE Access
n=41 Participants
behavioral pain self-management intervention (Pain EASE) delivered via the Internet
behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing
|
|---|---|
|
Numeric Rating Scale of Pain Intensity
|
-0.24 units on a scale
Interval -0.29 to 0.2
|
SECONDARY outcome
Timeframe: baseline and 10 weeks post-baselineTotal mood symptoms score reported. The 65-item Profile of Mood States (POMS) is a multidimensional measure of emotional functioning designed to assess six dimensions of mood "over the past week, including today". Each item is scored on a 0-5 Likert scale, where 0= "not at all" and 5= "extremely". Total Mood Disturbance score ranges from 0 to 200. Higher scores reflect poorer functioning. Lower scores correspond to better outcomes. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value).
Outcome measures
| Measure |
10 Week Pain EASE Access
n=41 Participants
behavioral pain self-management intervention (Pain EASE) delivered via the Internet
behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing
|
|---|---|
|
Profile of Mood States
|
-9.57 score on a scale
Interval -17.72 to -1.42
|
SECONDARY outcome
Timeframe: baseline and 10 weeks post-baselineGeneral fatigue scale reported. Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI), which is a 20 item measure that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and how subscale statements regarding fatigue represent their experiences. Score range from 4 to 20. Higher total scores correspond with more acute levels of fatigue. Lower scores correspond to better outcomes. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value).
Outcome measures
| Measure |
10 Week Pain EASE Access
n=41 Participants
behavioral pain self-management intervention (Pain EASE) delivered via the Internet
behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing
|
|---|---|
|
Multidimensional Fatigue Inventory
|
-0.3 score on a scale
Interval -1.17 to 0.56
|
SECONDARY outcome
Timeframe: baseline and 10 weeks post-baselineThe MOS Sleep Scale is a 12 item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, awaken short of breath or with headache, adequacy of sleep, somnolence, a problems index 1 and a problems index 2). An additional single item assesses quantity of sleep. The sleep domains and problems index are scored on a 0 - 100 possible range, and higher scores indicate more of the concept being measured. Lower scores on sleep disturbance, for example, reflect less disturbed sleep, which is a better outcome. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value).
Outcome measures
| Measure |
10 Week Pain EASE Access
n=41 Participants
behavioral pain self-management intervention (Pain EASE) delivered via the Internet
behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing
|
|---|---|
|
Medical Outcomes Study Sleep Scale
|
-4.95 score on a scale
Interval -12.27 to 2.38
|
SECONDARY outcome
Timeframe: baseline and 10 weeks post-baselineDepressive symptom severity was assessed using the 21-item Beck Depression Inventory. Scores range from 0 - 63. Higher scores indicate more severe depression symptomatology. Lower scores correspond to better outcomes (i.e., less depressive symptom severity). Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value).
Outcome measures
| Measure |
10 Week Pain EASE Access
n=41 Participants
behavioral pain self-management intervention (Pain EASE) delivered via the Internet
behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing
|
|---|---|
|
Beck Depression Inventory
|
-2.31 score on a scale
Interval -4.37 to -0.25
|
Adverse Events
10 Week Pain EASE Access
Serious adverse events
| Measure |
10 Week Pain EASE Access
n=58 participants at risk
behavioral pain self-management intervention (Pain EASE) for chronic low back pain delivered via the Internet
behavioral pain self-management intervention Pain EASE: 10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing
Access to the Pain EASE intervention for 10 weeks: analyses were conducted to determine change from baseline on pain-related functional interference and other outcomes
|
|---|---|
|
Psychiatric disorders
psychiatric emergency room visit
|
1.7%
1/58 • Number of events 1 • 10 weeks of active study participation
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place