K23- Physical Self Regulation vs Placebo

Conditions

• Temporomandibular Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Physical Self Regulation Telehealth — BEHAVIORAL
  2 sessions of an intervention delivered via telehealth. Session 1 includes awareness and strategies for monitoring habits and 4 exercises to practice 5 times per day. Session 2 will be 2 weeks later and is a review of session 1 and an introduction to diaphragmatic breathing. Breathing is practiced for 15 minutes twice per day.
• Psycho-education Telehealth — BEHAVIORAL
  2 sessions of an intervention delivered via telehealth. Session 1 includes discussing trigeminal nerve function, jaw and muscle anatomy, posture, pain referral patterns, and stress biology. Participants rate pain and jaw fatigue 5 times per day. Session 2 will be 2 weeks later and consists of checking on the homework and information from session 1,followed by a discussion of autonomic nervous system activity, and a discussion of sleep quality and sleep hygiene. Participants will be instructed to rate their stress levels, pain, and mood several times per day, similar to the times when participants in the PSR-TH condition would be practicing diaphragmatic breathing

Study Details

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.

Key Dates

Start date

Apr 4, 2024

Status verified

Jun 2026

Primary completion

Jun 1, 2028

Completion

Aug 31, 2028

Study Design

Enrollment

104 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Physical Self Regulation
  2 experimental telehealth sessions approximately 2 weeks apart
• Active Comparator: Psycho-education
  2 control telehealth sessions approximately 2 weeks apart

Primary Outcome Measure

Change in pain intensity [ Time Frame: Baseline (week 0), post intervention (week 5) and 3-month follow-up (week 15) ]

Central Contacts

• Courtney Brown
  8593230246
  [email protected]

Locations (1)

Find similar trials in Lexington, KY

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