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NCT06357702 · ClinicalTrials.gov registry record · NA
K23- Physical Self Regulation vs Placebo
A NA study of Temporomandibular Disorder, sponsored by Ian Boggero, PhD.
- Recruiting
- Registry status
- NA
- Development phase
- 104
- Enrollment target
- 1
- Study location
NCT06357702 is a NA study of Temporomandibular Disorder that is actively recruiting participants, run by Ian Boggero, PhD. The registered enrollment target is 104 participants, below the 122-participant average among 3 other Temporomandibular Disorder trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06357702, a NA study of Temporomandibular Disorder, is actively recruiting participants, sponsored by Ian Boggero, PhD.
- RECRUITING
- Registry status
- NA
- Development phase
- 104 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain called Physical Self-Regulation or a control intervention. Interventions will be administered via telehealth in both arms. Both interventions will consist of 2 50-minute sessions scheduled approximately two weeks apart. Participants will be contacted two weeks and three months after completing the interventions to provide additional follow-up data. Investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, \>75% retention, \>95% interventionist fidelity, and adequate acceptability, credibility, and burden). Investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects.
Conditions Studied
Interventions
- BEHAVIORAL Physical Self Regulation Telehealth
- BEHAVIORAL Psycho-education Telehealth
Study Locations (1)
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2024-04-04 |
| Est. Completion | 2028-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06357702
The ClinicalTrials.gov registry entry for NCT06357702 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 122-participant average among 3 other Temporomandibular Disorder trials with a reported enrollment target (15% lower). The listed sponsor is Ian Boggero, PhD, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Temporomandibular Disorder appearing as the primary indexed condition, and to 2 interventions - of which Physical Self Regulation Telehealth is the first listed.
NCT06357702 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.
Frequently Asked Questions
What is clinical trial NCT06357702 about?
NCT06357702 is a clinical study titled "K23- Physical Self Regulation vs Placebo". This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain ca...
What is the current status of trial NCT06357702?
This trial is currently recruiting. It is a NA study. The enrollment target is 104 participants. The study started on 2024-04-04. Estimated completion is 2028-08-31.
What conditions does trial NCT06357702 study?
This clinical trial studies the following conditions: Temporomandibular Disorder.
What interventions are being tested in trial NCT06357702?
The interventions under investigation include: Physical Self Regulation Telehealth (BEHAVIORAL), Psycho-education Telehealth (BEHAVIORAL).
Who is sponsoring clinical trial NCT06357702?
This trial is sponsored by Ian Boggero, PhD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06357702 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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