Clinical trial NCT04897581: BBTI vs PSR in Musculoskeletal Orofacial Pain Adults
Official title: Establishing the Effectiveness of BBTI vs. PSR on Sleep and Pain Parameters in Adults With Musculoskeletal Orofacial Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain
Myalgia
Keywords: local myalgia
centrally-mediated myalgia
masticatory pain
sleep
insomnia
behavioral therapy
self-regulation
depression
anxiety
fatigue
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
measure: 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)
measure: 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)
Secondary outcomes:
measure: Change in Self-report Sleep Quality
timeFrame: At pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention)
measure: Sleep architecture
timeFrame: Each morning and each evening from the first session to 2 weeks after the last session of the intervention
measure: Change in Self-report Depression Symptoms
timeFrame: At pre-intervention (one week before the first session of the intervention), at post-intervention (two weeks after the last session of the intervention) and every day during the intervention period
measure: Change in Self-report Anxiety Symptoms
timeFrame: At pre-intervention (one week before the first session of the intervention), at post-intervention (two weeks after the last session of the intervention) and every day during the intervention period
measure: Change in Self-report Headache Intensity
timeFrame: At pre-intervention (one week before the first session of the intervention), at post-intervention (two weeks after the last session of the intervention)
measure: Change in Self-report Headache Frequency
timeFrame: At pre-intervention (one week before the first session of the intervention), at post-intervention (two weeks after the last session of the intervention)
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Ian Boggero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ballou S, Katon J, Rangan V, Cheng V, Nee J, Iturrino J, Lembo A. Brief Behavioral Therapy for Insomnia in Patients with Irritable Bowel Syndrome: A Pilot Study. Dig Dis Sci. 2020 Nov;65(11):3260-3270. doi: 10.1007/s10620-020-06182-w. Epub 2020 Mar 9.