Tailored Self-Management of Temporomandibular Disorders (TMD) Using Health Information Technology

NCT03036215 | Completed Results

• 1 other identifier: 5U01DE025609-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Temporomandibular Joint Dysfunction Syndrome

Outcome Measures

Primary Outcomes (2)

• Assessing Graded Chronic Pain Severity Evaluation Feasibility of the PACT Program

  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)

  Change from baseline to 16 weeks post intervention

• Assessing Change in Jaw Functioning

  Jaw Functional Limitation Scale (JFLS-8) identifies daily activities interfered with by jaw pain - 8 items Scale 0-80 (80 more severe)

  Change from baseline to 16 weeks post intervention

Secondary Outcomes (1)

• Graded Chronic Pain Interference

  Change from baseline to 16 weeks post intervention

Study Arms (2)

Traditional Self-Care Control Arm

NO INTERVENTION

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

EXPERIMENTAL

If selected for the PACT care arm, participant will be prompted to complete 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. Participant will also participate in usual care from the dentist such as a splint or anti- inflammatory medications.Participant will complete follow-up measures at 8-weeks (post-intervention) and at 16-weeks (2 months after program end).

Behavioral: PACT Experimental Arm

Interventions

PACT Experimental Arm BEHAVIORAL

The study will employ 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.

PACT Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners Clinic

Saint Paul, Minnesota, 55108, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Condition Hierarchy (Ancestors)

Temporomandibular Joint Disorders; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Myofascial Pain Syndromes; Stomatognathic Diseases

Results Point of Contact

• Title: James Fricton, DDS, Senior Research Investigator
• Organization: HealthPartners Institute

james.r.fricton@healthpartners.com

6126191678

Study Officials

• James R. Fricton, DDS

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

• Robin R. Whitebird, PhD, MSW

  University of St Thomas , School of Social Work

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The pilot study design is a 2-arm randomized clinical trial to test the methods that will be used in a future proposal for a full-scale multi-site clinical trial. The two aims include: 1) evaluate the feasibility of methods to conduct a full-scale multi-site randomized clinical trial comparing the PACT self-management with usual self-care for TMD and, 2) estimate the parameters needed to plan for a larger multi-site trial including the effect size and standard deviation for primary outcomes of pain and function. A traditional self-care control arm is added to determine the acceptability of randomization and the feasibility of collecting baseline and follow-up data from a traditional care control arm for the full-scale study.

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 30, 2017
• Study Start: May 8, 2017
• Primary Completion: November 9, 2017
• Study Completion: November 9, 2017
• Last Updated: June 15, 2018
• Results First Posted: June 15, 2018

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)