Myofascial PainBBTI_PSR_21NCT04897581
BBTI vs PSR in Musculoskeletal Orofacial Pain Adults
A study testing Brief Behavioral Therapy for Insomnia, BBTI and Physical Self-Regulation, PSR in people with Myofascial Pain and Myalgia, run by Ian Boggero, PhD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Pain, Myalgia
- What is being tested?
- Brief Behavioral Therapy for Insomnia, BBTI and Physical Self-Regulation, PSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2021to 23 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- less than 18 years old
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Brief Behavioral Therapy for Insomnia, BBTI, Physical Self-Regulation, PSR
- Keywords
- local myalgia, centrally-mediated myalgia, masticatory pain, sleep, insomnia, behavioral therapy, self-regulation, depression, anxiety, fatigue
- Medical subject headings
- Myalgia, Sleep Initiation and Maintenance Disorders, Self-Control, Depression, Anxiety Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Therapy for Insomnia, BBTIBehavioural
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, PSRBehavioural
PSR is conducted over telehealth and consists of three 50-minute sessions focused on jaw relaxation exercises, proprioceptive awareness training, and diaphragmatic breathing entrainment.
| Study group | Role | What they receive |
|---|---|---|
| Brief Behavioral Therapy for Insomnia, BBTI | Experimental | Participants in this group will receive 3 sessions of BBTI over telehealth. Receives: Behavioral: Brief Behavioral Therapy for Insomnia, BBTI |
| Physical Self-Regulation, PSR | Experimental | Participants in this group will receive 3 sessions of PSR over telehealth. Receives: Behavioral: Physical Self-Regulation, PSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 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.
Measured: At pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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. �
Measured: 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. �
Measured: 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".
Measured: 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.
Measured: At pre-intervention (one week before the first session of the intervention), at post-intervention (two weeks after the last session of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start21 Oct 2021
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ian Boggero, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ian Boggero, PhD, University of Kentucky
- Investigators
- Ian Boggero, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897581
- Sponsor's protocol ID
- 65092
- Acronym
- BBTI_PSR_21
- Status last verified
- Jun 2026
- First submitted
- 14 May 2021
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 32152868
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Effectiveness of BBTI vs. PSR on Sleep and Pain Parameters in Adults With Musculoskeletal Orofacial Pain
- ClinicalTrials.gov ID
- NCT04897581
- Acronym / sponsor ID
- BBTI_PSR_21 / 65092
- Conditions
- Myofascial Pain, Myalgia
- Keywords
- local myalgia, centrally-mediated myalgia, masticatory pain, sleep, insomnia, behavioral therapy, self-regulation, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Ian Boggero, PhDUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Therapy for Insomnia, BBTI | Experimental | Behavioral: Brief Behavioral Therapy for Insomnia, BBTIParticipants in this group will receive 3 sessions of BBTI over telehealth. |
| Physical Self-Regulation, PSR | Experimental | Behavioral: Physical Self-Regulation, PSRParticipants in this group will receive 3 sessions of PSR over telehealth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- less than 18 years old
- unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Behavioral Therapy for Insomnia, BBTIBBTI includes sleep hygiene, stimulus control, and sleep restriction, and is administered in three 50-minute sessions over telehealth by psychologic team. | Behavioural | Brief Behavioral Therapy for Insomnia, BBTI |
| Physical Self-Regulation, PSRPSR is conducted over telehealth and consists of three 50-minute sessions focused on jaw relaxation exercises, proprioceptive awareness training, and diaphragmatic breathing entrainment. | Behavioural | Physical Self-Regulation, PSR |
Primary outcome
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.
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".
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.
6 secondary outcomes
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)
Sleep architecture
Time frame: 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
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
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
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 32152868Ballou 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Boggero, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Therapy for Insomnia, BBTI and Physical Self-Regulation, PSR in people with Myofascial Pain and Myalgia, run by Ian Boggero, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04897581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.