Temporomandibular Joint Dysfunction SyndromeTMDPACTNCT03036215
Tailored Self-Management of Temporomandibular Disorders (TMD) Using Health Information Technology
A study testing PACT Experimental Arm in people with Temporomandibular Joint Dysfunction Syndrome, run by HealthPartners Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Dysfunction Syndrome
- What is being tested?
- PACT Experimental Arm
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2017to 9 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailored Self-Management of TMD Pain Using Health Information Technology
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.
Read the detailed description
The primary study objectives of the PACT study are two-fold:
- Evaluate the feasibility of methods to conduct a full-scale multi-site randomized clinical trial comparing PACT self-management with traditional self-care for TMD. The study will also evaluate strategies to: identify, recruit, consent, and enroll eligible subjects into both groups meeting target goal; evaluate adherence to intervention and identification of barriers; evaluate adherence to outcomes assessment, and evaluate the on-line web-site functionality and acceptability.
- To demonstrate ability to accurately capture outcome measures to be used in the multi-site study.
Primary study objective: Recruitment is measured through achievement of target sample, number of patients identified that meet eligibility criteria, and number (%) of subjects consenting compared with total contacted.
Intervention adherence is measured by: number of participants enrolled in both groups, number of participants accessing on-line materials, completion of practice logs, and identification of self-reported barriers of participation in self-care. Outcome adherence is measured by the number of participants who complete the baseline assessment, complete the two and four month follow-up assessments, complete the program evaluation, and complete qualitative post-study interview. Website acceptability is measure by identification of problems and barriers during use and quality and ease of use at the post-intervention evaluation.
Second objective: Efficacy of the program is measured by self-reported outcome assessments. The primary outcomes include TMD symptoms, jaw functioning, and emotional functioning. Secondary outcomes measures include symptom severity with the temporal aspects of pain, pain interference, and patient ratings of improvement. Additional information on mediators and modifiers will also be gathered to help inform the how and why the intervention has an effect. Mediators will be measured to identify factors that help explain why PACT may have an effect including self-efficacy, patient activation, exercise level, sleep quality, and social support. Contextual process factors to identify in whom the intervention does and does not work include disability status, catastrophizing, depression, repetitive strain from oral habits, and perceived stress.
- Being tested
- PACT Experimental Arm
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACT Experimental ArmBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: PACT Experimental Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Change from baseline to 16 weeks post intervention
Secondary outcomes (1)
Graded Chronic Pain Interference
Assessment 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.
Measured: Change from baseline to 16 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start8 May 2017
- Primary completion9 Nov 2017
- Study completion9 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Temporomandibular Joint Dysfunction SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James R. Fricton, DDS, Principal investigator, HealthPartners InstituteRobin R. Whitebird, PhD, MSW, Principal investigator, University of St Thomas , School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036215
- Sponsor's protocol ID
- 5U01DE025609-02
- Acronym
- TMDPACT
- Status last verified
- Jan 2017
- First submitted
- 18 Jan 2017
- Last updated
- 15 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Self-Management of TMD Pain Using Health Information Technology
- ClinicalTrials.gov ID
- NCT03036215
- Acronym / sponsor ID
- TMDPACT / 5U01DE025609-02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 9 Nov 2017 (actual)
- Study completion
- 9 Nov 2017 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Posted 15 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary study objectives of the PACT study are two-fold:
- Evaluate the feasibility of methods to conduct a full-scale multi-site randomized clinical trial comparing PACT self-management with traditional self-care for TMD. The study will also evaluate strategies to: identify, recruit, consent, and enroll eligible subjects into both groups meeting target goal; evaluate adherence to intervention and identification of barriers; evaluate adherence to outcomes assessment, and evaluate the on-line web-site functionality and acceptability.
- To demonstrate ability to accurately capture outcome measures to be used in the multi-site study.
Primary study objective: Recruitment is measured through achievement of target sample, number of patients identified that meet eligibility criteria, and number (%) of subjects consenting compared with total contacted.
Intervention adherence is measured by: number of participants enrolled in both groups, number of participants accessing on-line materials, completion of practice logs, and identification of self-reported barriers of participation in self-care. Outcome adherence is measured by the number of participants who complete the baseline assessment, complete the two and four month follow-up assessments, complete the program evaluation, and complete qualitative post-study interview. Website acceptability is measure by identification of problems and barriers during use and quality and ease of use at the post-intervention evaluation.
Second objective: Efficacy of the program is measured by self-reported outcome assessments. The primary outcomes include TMD symptoms, jaw functioning, and emotional functioning. Secondary outcomes measures include symptom severity with the temporal aspects of pain, pain interference, and patient ratings of improvement. Additional information on mediators and modifiers will also be gathered to help inform the how and why the intervention has an effect. Mediators will be measured to identify factors that help explain why PACT may have an effect including self-efficacy, patient activation, exercise level, sleep quality, and social support. Contextual process factors to identify in whom the intervention does and does not work include disability status, catastrophizing, depression, repetitive strain from oral habits, and perceived stress.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: PACT Experimental ArmIf 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Key exclusion criteria (5 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACT Experimental ArmThe 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. | Behavioural | PACT Experimental Arm |
Primary outcome
Assessing Graded Chronic Pain Severity Evaluation Feasibility of the PACT Program
Time frame: Change from baseline to 16 weeks post intervention
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)
Assessing Change in Jaw Functioning
Time frame: Change from baseline to 16 weeks post intervention
Jaw Functional Limitation Scale (JFLS-8) identifies daily activities interfered with by jaw pain - 8 items Scale 0-80 (80 more severe)
1 secondary outcome
Graded Chronic Pain Interference
Time frame: Change from baseline to 16 weeks post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James R. Fricton, DDS principal investigator
HealthPartners Institute
Robin R. Whitebird, PhD, MSW principal investigator
University of St Thomas , School of Social Work
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACT Experimental Arm in people with Temporomandibular Joint Dysfunction Syndrome, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing Graded Chronic Pain Severity Evaluation Feasibility of the PACT Program (time frame: Change from baseline to 16 weeks post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.