BBTI vs PSR in Musculoskeletal Orofacial Pain Adults
Purpose
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.
Conditions
- Myofascial Pain
- Myalgia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
- Masking Description
- Data will be coded such that the Principal Investigator (PI) analyzing the data will be blind to conditions to prevent bias during the data collection and analysis. Also, the PI will remain blind through the study and will not provide either of the interventions. The statistician will be blind. The examiner will collect the data after de-identification of the sensitive and identifiable data.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Brief Behavioral Therapy for Insomnia, BBTI |
Participants in this group will receive 3 sessions of BBTI over telehealth. |
|
|
Experimental Physical Self-Regulation, PSR |
Participants in this group will receive 3 sessions of PSR over telehealth. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04897581
- Status
- Completed
- Sponsor
- Ian Boggero, PhD
Detailed Description
New patients who come into the orofacial pain clinic are evaluated by a dental resident and given an orofacial pain diagnosis. If this primary diagnosis involves masticatory myofascial pain, local myalgia, or centrally-mediated myalgia, and if patients self-report poor sleep, they will be introduced to the study. An initial evaluation for PSR and BBTI will be scheduled over telehealth. If willing and eligible to participate, at the end of this first evaluation, they will be provided with an informed consent form and be randomly assigned to three sessions of PSR or three sessions of BBTI. After providing an e-consent, they will be sent a questionnaire battery on REDCap to assess their outcomes at pre-intervention. A REDCap daily questionnaire will be sent every day (morning and evening) starting one week before session 1 of the intervention, until two weeks after the last session. Moreover, to a small group of patients randomly selected, an actigraphy watch will be mailed. Two weeks after the last session of the intervention, a REDCap questionnaire will be sent to assess their outcomes at post-intervention. As per the current clinical protocol, all participants will be offered both interventions; only data from the first intervention will be utilized for the current study. All PSR and BBTI sessions will be conducted via telehealth using a HIPAA-compliant zoom account.