Trial Outcomes & Findings for Tailored Self-Management of Temporomandibular Disorders (TMD) Using Health Information Technology (NCT NCT03036215)
NCT ID: NCT03036215
Last Updated: 2018-06-15
Results Overview
Measure: Graded Chronic Pain Scale (GCPS) with mean intensity ratings for reported current, worst, and average pain. 3 items: Scale 0-100 (100 most severe)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Change from baseline to 16 weeks post intervention
Results posted on
2018-06-15
Participant Flow
Participant milestones
| Measure |
Traditional Self-Care Control Arm
Traditional self-care focuses on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants in the traditional arm may also be receiving usual care from their dentist such as a splint or anti-inflammatory medications. They will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end).
|
PACT Experimental Arm
Participants enrolled in the experimental arm are prompted to complete a self-management program, Personalized Activated Care and Training (PACT), The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors designed to improve TMD pain. Participants also complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). These participants are also supported by a health coach.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
39
|
|
Overall Study
COMPLETED
|
39
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tailored Self-Management of Temporomandibular Disorders (TMD) Using Health Information Technology
Baseline characteristics by cohort
| Measure |
Traditional Self-Care Control Arm
n=41 Participants
Traditional self-care includes focusing on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants will also participate in usual care from the dentist such as a splint or anti-inflammatory medications. Participants will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). .
|
PACT Experimental Arm
n=39 Participants
PACT Experimental Arm: The study employs a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors that have evidence of improving TMD pain.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
46 years
STANDARD_DEVIATION 17.1 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
39 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Graded Chronic Pain Severity
|
50 units on a scale
STANDARD_DEVIATION 15 • n=5 Participants
|
50 units on a scale
STANDARD_DEVIATION 17.6 • n=7 Participants
|
50 units on a scale
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Graded Chronic Pain interference
|
26.6 units on a scale
STANDARD_DEVIATION 23.7 • n=5 Participants
|
23 units on a scale
STANDARD_DEVIATION 21.3 • n=7 Participants
|
24.9 units on a scale
STANDARD_DEVIATION 22.5 • n=5 Participants
|
|
Jaw Functioning
|
24.5 units on a scale
STANDARD_DEVIATION 18.9 • n=5 Participants
|
19.4 units on a scale
STANDARD_DEVIATION 14 • n=7 Participants
|
22 units on a scale
STANDARD_DEVIATION 16.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 16 weeks post interventionMeasure: Graded Chronic Pain Scale (GCPS) with mean intensity ratings for reported current, worst, and average pain. 3 items: Scale 0-100 (100 most severe)
Outcome measures
| Measure |
Traditional Self-Care Control Arm
n=39 Participants
Traditional self-care focuses on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants in the traditional arm may also be receiving usual care from their dentist such as a splint or anti-inflammatory medications. They will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end).
|
PACT Experimental Arm
n=36 Participants
Participants enrolled in the experimental arm are prompted to complete a self-management program, Personalized Activated Care and Training (PACT), The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors designed to improve TMD pain. Participants also complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). These participants are also supported by a health coach.
|
|---|---|---|
|
Assessing Graded Chronic Pain Severity Evaluation Feasibility of the PACT Program
|
-12 units on a scale
Standard Deviation 16.8
|
-19 units on a scale
Standard Deviation 16
|
PRIMARY outcome
Timeframe: Change from baseline to 16 weeks post interventionJaw Functional Limitation Scale (JFLS-8) identifies daily activities interfered with by jaw pain - 8 items Scale 0-80 (80 more severe)
Outcome measures
| Measure |
Traditional Self-Care Control Arm
n=39 Participants
Traditional self-care focuses on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants in the traditional arm may also be receiving usual care from their dentist such as a splint or anti-inflammatory medications. They will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end).
|
PACT Experimental Arm
n=36 Participants
Participants enrolled in the experimental arm are prompted to complete a self-management program, Personalized Activated Care and Training (PACT), The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors designed to improve TMD pain. Participants also complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). These participants are also supported by a health coach.
|
|---|---|---|
|
Assessing Change in Jaw Functioning
|
-7.9 units on a scale
Standard Deviation 14.9
|
-6.9 units on a scale
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: Change from baseline to 16 weeks post interventionAssessment of graded Chronic Pain Interference - Scale (0-100); 0 = lowest pain interference 100 = highest pain interference. If findings in negative values = improvement; positive values = worsening condition.
Outcome measures
| Measure |
Traditional Self-Care Control Arm
n=39 Participants
Traditional self-care focuses on rest and healing through changes in chewing, diet, heat/cold, over the counter analgesics, and reducing strain from oral and sleeping habits. Participants in the traditional arm may also be receiving usual care from their dentist such as a splint or anti-inflammatory medications. They will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end).
|
PACT Experimental Arm
n=36 Participants
Participants enrolled in the experimental arm are prompted to complete a self-management program, Personalized Activated Care and Training (PACT), The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors designed to improve TMD pain. Participants also complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end). These participants are also supported by a health coach.
|
|---|---|---|
|
Graded Chronic Pain Interference
|
-5.8 units on a scale
Standard Deviation 20.7
|
-11 units on a scale
Standard Deviation 17.2
|
Adverse Events
Traditional Self-Care Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PACT Experimental Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
James Fricton, DDS, Senior Research Investigator
HealthPartners Institute
Phone: 6126191678
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place