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NCT04897581 · ClinicalTrials.gov registry record · NA
BBTI vs PSR in Musculoskeletal Orofacial Pain Adults
A NA study of Myofascial Pain and Myalgia, sponsored by Ian Boggero, PhD.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT04897581: Completed NA study of Myofascial Pain and Myalgia, sponsored by Ian Boggero, PhD.
NCT04897581 is a NA study of Myofascial Pain and Myalgia that has completed, run by Ian Boggero, PhD. The registered enrollment target is 19 participants, below the 72-participant average among 8 other Myofascial Pain trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04897581, a NA study of Myofascial Pain and Myalgia, has completed, sponsored by Ian Boggero, PhD.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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-of
Conditions Studied
Interventions
- BEHAVIORAL Brief Behavioral Therapy for Insomnia, BBTI
- BEHAVIORAL Physical Self-Regulation, PSR
Study Locations (1)
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-10-21 |
| Est. Completion | 2023-05-23 |
| Phase | NA |
What the finished NCT04897581 record still lists
NCT04897581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 72-participant average among 8 other Myofascial Pain trials with a reported enrollment target (74% lower).
The record links to 2 conditions, with Myofascial Pain appearing as the primary indexed condition, and to 2 interventions - of which Brief Behavioral Therapy for Insomnia, BBTI is the first listed.
NCT04897581 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT04897581 about?
NCT04897581 is a clinical study titled "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 p...
What is the current status of trial NCT04897581?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2021-10-21. Estimated completion is 2023-05-23.
What conditions does trial NCT04897581 study?
This clinical trial studies the following conditions: Myofascial Pain, Myalgia.
What interventions are being tested in trial NCT04897581?
The interventions under investigation include: Brief Behavioral Therapy for Insomnia, BBTI (BEHAVIORAL), Physical Self-Regulation, PSR (BEHAVIORAL).
Who is sponsoring clinical trial NCT04897581?
This trial is sponsored by Ian Boggero, PhD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04897581 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04897581's enrollment target sits among peer trials
19 9th of 8 the lowest of 8 other Myofascial Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myofascial Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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