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.
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.
| Condition | muscle pains, myalgias, Muscle Pain, Myalgia, muscular pain, Muscle Soreness, Myofascial Pain, pain, muscle |
|---|---|
| Treatment | Brief Behavioral Therapy for Insomnia, BBTI, Physical Self-Regulation, PSR |
| Clinical Study Identifier | NCT04897581 |
| Sponsor | Linda Sangalli |
| Last Modified on | 30 March 2023 |
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