BBTI vs PSR in Musculoskeletal Orofacial Pain Adults (NCT04897581) | Clinical Trial Compass
CompletedNot Applicable
BBTI vs PSR in Musculoskeletal Orofacial Pain Adults
United States19 participantsStarted 2021-10-21
Plain-language summary
This clinical study aims to compare the efficacy of two brief psychological interventions: Brief Behavioral Therapy for Insomnia (BBIT) and Physical Self-Regulation or (PSR) delivered over telehealth for the management of chronic musculoskeletal orofacial pain conditions (local myalgia, myofascial pain, centrally mediated myalgia) in a tertiary orofacial pain clinic. It is hypothesized that both interventions will produce beneficial changes and exploratory analysis will aim to establish which intervention -if any- is better for each specific outcome.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* present with a score on Insomnia Severity Index \> 15
* have a primary diagnosis of chronic (onset more than 3 months before) MSK pain (myofascial pain and/or local myalgia and/or centrally mediated myalgia) from a board-certified orofacial pain specialist at UK Orofacial Pain Clinic
* maintain a stable medication regime in previous month and during the intervention
* older than 18 years old
* able to understand English
* willing to participate to telehealth intervention
* have internet access and an email address
* present with total STOP BANG score \< 5
Exclusion Criteria:
* less than 18 years old
* unable to provide informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Self-report Insomnia Symptoms
Timeframe: At pre-intervention (1 week before starting with the intervention) and post-intervention (2 weeks after the last session of the intervention)
2
Change in Self-report Average Pain Intensity
Timeframe: At pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention)
3
Change in Self-report Quality of Life
Timeframe: At pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention)