NCT04897581

BBTI vs PSR in Musculoskeletal Orofacial Pain Adults

Establishing the Effectiveness of BBTI vs. PSR on Sleep and Pain Parameters in Adults With Musculoskeletal Orofacial Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Ian Boggero, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Myofascial Pain
• Myalgia

Interventions

Type	Name	Description
BEHAVIORAL	Brief Behavioral Therapy for Insomnia, BBTI	BBTI includes sleep hygiene, stimulus control, and sleep restriction, and is administered in three 50-minute sessions over telehealth by psychologic team.
BEHAVIORAL	Physical Self-Regulation, PSR	PSR is conducted over telehealth and consists of three 50-minute sessions focused on jaw relaxation exercises, proprioceptive awareness training, and diaphragmatic breathing entrainment.

Timeline

• Start date: 2021-10-21
• Primary completion: 2023-05-23
• Completion: 2023-05-23
• First posted: 2021-05-21
• Last updated: 2023-06-06

Locations

1 site across 1 country: United States