BBTI vs PSR in Musculoskeletal Orofacial Pain Adults (BBTI_PSR_21)

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

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.

Study Overview

• Status: Completed
• Conditions: Myalgia; Myofascial Pain
• Intervention / Treatment: Behavioral: Brief Behavioral Therapy for Insomnia, BBTI; Behavioral: Physical Self-Regulation, PSR

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief Behavioral Therapy for Insomnia, BBTI; Participants in this group will receive 3 sessions of BBTI over telehealth.	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.
Experimental: Physical Self-Regulation, PSR; Participants in this group will receive 3 sessions of PSR over telehealth.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-report Insomnia Symptoms	Insomnia symptomatology will be assessed via the Insomnia Severity Index (ISI). The ISI includes seven items (sleep-onset, sleep maintenance, early morning awakening, satisfaction with current sleep pattern, interference with daily functioning, impairment attributed to sleep problems, distress caused by sleep problems), related to the prior 2 weeks on a five-point Likers scale (0= no problem, 4 = severe problem). The total score ranges from 0 to 28, with 28 indicating severe insomnia. The cut-off for the present study is 15. The ISI has good internal consistency and is demonstrated to be sensitive to changes in sleep of older adults following behavioral treatment for insomnia. Clinical improvement is defined as a reduction of ISI below the cut-off of 15.	At pre-intervention (1 week before starting with the intervention) and post-intervention (2 weeks after the last session of the intervention)
Change in Self-report Average Pain Intensity	The average pain intensity will be assessed using a Numeric Rating Scale (NRS) on a 10-point scale, where 0 coincides with "no pain" and 10 coincides with "worse pain ever felt".	At pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention)
Change in Self-report Quality of Life	The overall quality of life will be assessed with 12-Item Short Form Health Survey (SF-12), a 12-item questionnaire designed to measure general health by addressing eight domains: limitations in social, physical, usual role activities because of physical health and emotional problems; bodily pain; general mental health; vitality; general health perceptions. SF-12 has been shown to reflect change over time like the long form SF-36 and to demonstrate good reliability and validity . Studies have addressed the impact of orofacial pain and sleep problems on health-related quality of life. The average score of the US population is set at 50. A score below this cut-off identifies a poor self-report quality of life.	At pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-report Sleep Quality	The sleep quality will be assessed via the RU-SATED, constituted by 6 items. RU-SATED appears to be a valid instrument for the assessment of sleep health among adults that is related to, but distinct from, other established sleep constructs. It provides a score from 0 to 12, with response to 6 questions. The lower the score, the worse the self-report sleep quality of the patient.	At pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention)
Sleep architecture	Sleep architecture will be assessed subjectively via daily morning and evening sleep diaries, sent to the participants via a REDCap survey. It will be assessed objectively via an actigraphy watch. The measured variables are sleep efficiency (SE), total sleep time (TST), sleep onset latency (SOL), number of awakening per night (NOA). For such variable, the change in outcomes will be collected; therefore, there is not a scale for measuring the change.	Each morning and each evening from the first session to 2 weeks after the last session of the intervention
Change in Self-report Depression Symptoms	Depression symptoms will be assessed at pre- and post-intervention via Pain-Health Questionnaire-4 (PHQ4). The Pain-Health Questionnaire (PHQ, 4 items) allows for a brief and accurate measurement of signs/symptoms of anxiety and depression, by providing an overall measure of symptom burden, as well as functional impairment and disability with a 4-point scale . PHQ-4 has demonstrated strong psychometric properties and have been validated for use in the general population. The first two questions of PHQ4 (PHQ-2) consists of core criteria for depression. The score goes from 0 to 4 for each question (for a total of 8, being 8 the most severe depression symptoms), and a score of 3 or above on the Depression subscale represent a reasonable cut off point for identifying potential cases of depression and a psychologist or counselor referral will be offered. Depression symptoms will be also monitored daily via morning and evening daily diaries, sent to the participant via a REDCap survey. �	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
Change in Self-report Anxiety Symptoms	Anxiety symptoms will be assessed at pre- and post-intervention via Pain-Health Questionnaire-4 (PHQ4). The Pain-Health Questionnaire (PHQ, 4 items) allows for a brief and accurate measurement of signs/symptoms of anxiety and depression, by providing an overall measure of symptom burden, as well as functional impairment and disability with a 4-point scale. PHQ-4 has demonstrated strong psychometric properties and have been validated for use in the general population. The last two questions (GAD-2) consists of core criteria for anxiety, with score going from 0 (no symptoms) to 4 (most severe anxiety symptoms) for each question. A score of 3 or above on the Anxiety subscale represents a reasonable cut off point for identifying potential cases of depression and a psychologist or counselor referral will be offered. Anxiety and depression symptoms will be also monitored daily via morning and evening daily diaries, sent to the participant via a REDCap survey. �	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
Change in Self-report Headache Intensity	Headache measures will investigate the severity of headache on a 10-point scale (Numeric Rating Scale, NRS), with 0 identifying "no pain", and 10 identifying "the worst pain experienced".	At pre-intervention (one week before the first session of the intervention), at post-intervention (two weeks after the last session of the intervention)
Change in Self-report Headache Frequency	This questionnaire investigate headache disability (in terms of lack of productivity, missing working days or school days), frequency and intensity will be also assessed using the Migraine Disability Assessment Test (MIDAS, 6-item). Each item identifies the total number of days per month of headache frequency (being 0 "no days of headache" and being 30 "each day with headache"). The minimum score is 0, the maximum is 150, with the upper limit identifying the highest frequency of headaches.	At pre-intervention (one week before the first session of the intervention), at post-intervention (two weeks after the last session of the intervention)

Collaborators and Investigators

• Sponsor: Ian Boggero, PhD
• Investigators: Principal Investigator: Ian Boggero, PhD, University of Kentucky

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: fatigue; sleep; depression; insomnia; anxiety; self-regulation; behavioral therapy; local myalgia; centrally-mediated myalgia; masticatory pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Facial Pain
• Other Study ID Numbers: 65092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

The data will be de-identified from the sensible data information. The data will be retained for 5 years after the end of the study. There is no intension to share the IPD with other researchers.

However, the data collected from this study will be utilised by the investigators for possible future studies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No