BBTI vs PSR in Musculoskeletal Orofacial Pain Adults

NCT04897581 | Completed

• 1 other identifier: 65092
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Pain; Myalgia

Keywords

local myalgia; centrally-mediated myalgia; masticatory pain; sleep; insomnia; behavioral therapy; self-regulation; depression; anxiety; fatigue

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Change in Self-report Sleep Quality

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

• Sleep architecture

  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

  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

  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

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

Study Arms (2)

Brief Behavioral Therapy for Insomnia, BBTI

EXPERIMENTAL

Participants in this group will receive 3 sessions of BBTI over telehealth.

Behavioral: Brief Behavioral Therapy for Insomnia, BBTI

Physical Self-Regulation, PSR

EXPERIMENTAL

Participants in this group will receive 3 sessions of PSR over telehealth.

Behavioral: Physical Self-Regulation, PSR

Interventions

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.

Brief Behavioral Therapy for Insomnia, BBTI

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.

Physical Self-Regulation, PSR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• less than 18 years old
• unable to provide informed consent

Sponsors & Collaborators

• Ian Boggero, PhD: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

• 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.

  PMID: 32152868 BACKGROUND

MeSH Terms

Conditions

Myalgia; Sleep Initiation and Maintenance Disorders; Self-Control; Depression; Anxiety Disorders; Fatigue

Interventions

phosphatidylserine receptor

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Social Behavior; Behavior; Behavioral Symptoms

Study Officials

• Ian Boggero, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data will be coded such that the Principal Investigator (PI) analyzing the data will be blind to conditions to prevent bias during the data collection and analysis. Also, the PI will remain blind through the study and will not provide either of the interventions. The statistician will be blind. The examiner will collect the data after de-identification of the sensitive and identifiable data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 21, 2021
• Study Start: October 21, 2021
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)