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Completed

NCT Number: NCT04897581

BBTI vs PSR in Musculoskeletal Orofacial Pain Adults

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.

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Key information

Conditions

Myofascial Pain Anxiety Disorders Behavior Behavioral Symptoms Depression Dyssomnias Fatigue Mental Disorders Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Self-Control Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Behavioral Therapy for Insomnia, BBTI

Behavioral

BBTI includes sleep hygiene, stimulus control, and sleep restriction, and is administered in three 50-minute sessions over telehealth by psychologic team.

Physical Self-Regulation, PSR

Behavioral

PSR is conducted over telehealth and consists of three 50-minute sessions focused on jaw relaxation exercises, proprioceptive awareness training, and diaphragmatic breathing entrainment.

Primary outcomes

  1. Change in Self-report Insomnia Symptoms

    Time frame: At pre-intervention (1 week before starting with the intervention) and post-intervention (2 weeks after the last session of the intervention)

    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.

  2. Change in Self-report Average Pain Intensity

    Time frame: At pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention)

    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".

  3. Change in Self-report Quality of Life

    Time frame: At pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention)

    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.

Secondary outcomes

  1. Change in Self-report Sleep Quality

    Time frame: At pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention)

    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.

  2. Sleep architecture

    Time frame: Each morning and each evening from the first session to 2 weeks after the last session of the intervention

    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.

  3. Change in Self-report Depression Symptoms

    Time frame: 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

    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. �

  4. Change in Self-report Anxiety Symptoms

    Time frame: 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

    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. �

  5. Change in Self-report Headache Intensity

    Time frame: At pre-intervention (one week before the first session of the intervention), at post-intervention (two weeks after the last session of the intervention)

    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".

  6. Change in Self-report Headache Frequency

    Time frame: At pre-intervention (one week before the first session of the intervention), at post-intervention (two weeks after the last session of the intervention)

    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.

Sponsors and collaborators

Lead sponsor

Ian Boggero, PhD

Other

Registry information

Official study title

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

Acronym: BBTI_PSR_21

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 21, 2021
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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