N/A
N=80
Tailored Self-Management of Temporomandibular Disorders (TMD) Using Health Information Technology
Temporomandibular Joint Dysfunction Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03036215 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Assessing Graded Chronic Pain Severity Evaluation Feasibility of the PACT Program — -12; -19 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PACT Experimental Arm (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HealthPartners Institute
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessing Graded Chronic Pain Severity Evaluation Feasibility of the PACT Program |
-12; -19 | — |
| PRIMARY Assessing Change in Jaw Functioning |
-7.9; -6.9 | — |
| SECONDARY Graded Chronic Pain Interference |
-5.8; -11 | — |
Summary
The purpose of this pilot project is to determine the feasibility and acceptability of proposed methods for a subsequent clinical trial of a tailored self-management program (PACT) designed to decrease pain in participants with temporomandibular disorders (TMD). The PACT program is a personalized program of exercise and behavioral changes implemented through a web-based program supported by a health coach. For this feasibility and acceptability study, 80 adults with TMD pain will be randomized either to the PACT program or to traditional self-care.
Eligibility Criteria
Inclusion Criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age 18 or older
- Able and willing to access the internet on a regular basis
- Able to read and speak English
- Be willing to comply with all study procedures:
- Randomly assigned to either arm of the study
- Be available for the duration of the study
- Complete study data collection forms
- Reachable by phone and able to participate in weekly phone coaching calls if randomized to the PACT arm
- Have a diagnosis of TMD pain using a self-report screener. These questions include;
- In the last 30 days, which of the following best describes any pain in your jaw or temple area on either side?
- In the last 30 days, have you had pain or stiffness in your jaw on awakening?
- In the last 30 days, did the following activities change any pain (that is, make it better or make it worse) in your jaw or temple area on either side? Chewing hard or tough food, Opening your mouth or moving your jaw forward or to the side, Jaw habits such as holding teeth together, clenching/grinding, or chewing gum, or other jaw activities such as talking, kissing, or yawning
- Frequency of TMD pain more than once a week with pain in the past 6 months
- Electronically sign an informed consent form
Exclusion Criteria
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Currently participating in any other TMD and temporomandibular joint (TMJ) related studies
- Major disk disorder that requires opioids or surgery for TMD pain
- Serious medical condition that might interfere with or prohibit participation in an online program or pregnancy
- Treatment for a mental health disorder or substance abuse in the past six months
Data sourced from ClinicalTrials.gov (NCT03036215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.