Self-management program for chronic orofacial pain from temporomandibular disorder.
Orofacial Pain Self-management: Personality Moderation Effect - Randomized Clinical Trial
This will test whether a self-management program helps adults (18–65) with chronic TMD-related orofacial pain reduce pain and improve function compared with guideline-based care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fundación Universidad Católica de Valencia San Vicente Mártir Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT06932406 on ClinicalTrials.gov |
What this trial studies
This randomized clinical trial enrolls 98 adults (18–65) with chronic temporomandibular disorder (TMD) pain and assigns them to a self-management program or to treatment based on TMD clinical practice guidelines. The self-management arm combines therapeutic education, cognitive-behavioral techniques, and therapeutic exercise, while the comparator follows conventional guideline-recommended care. Outcomes include pain perception, functional measures, and psychosocial variables, collected at baseline, five weeks, and six months. The analysis will also test whether personality traits and related factors (stress perception, coping, anxiety) moderate the treatment effect.
Who should consider this trial
Good fit: Adults aged 18–65 with a DC/TMD diagnosis, chronic orofacial pain (≥2 hours/day on ≥50% of days for the past 3 months), and at least moderate weekly pain (≥30 mm on a 100 mm VAS) are ideal candidates.
Not a fit: Patients with systemic rheumatic disease, recent head/neck trauma or surgery, odontogenic or infectious dental pain, neuropathic facial pain, or those already receiving ongoing therapy (beyond rescue medications) are excluded and may not benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could provide a scalable way to reduce pain and improve function and coping for people with chronic TMD-related orofacial pain.
How similar studies have performed: Previous self-management and CBT-based programs for chronic pain have shown modest improvements in pain and function, but applying personality traits as moderators specifically in TMD is less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient presents TMDs diagnosed according to the CD/TMD classification. * Age between 18 and 65. * Presence of pain in mandibular, temporal, facial, peri-auricular and/or auricular regions. * Presence of chronic orofacial pain. Defined by the ICD-11 as orofacial pain or headache that occurs for more than two hours a day for 50% of the days of the last three months. * Orofacial pain is related to TMDs according to the International Classification of Headaches. * Moderate pain intensity, corresponding to a weekly average of at least 30 mm on a 100 mm VAS (validated representation of moderate pain on the VAS scale = 31-54 mm) Exclusion Criteria: * Concomitant rheumatic systemic pathologies. * History of trauma or recent surgical intervention in the head, face, neck or chest. * Presence of intraoral infections or odontogenic pain. * Headache of neuropathic origin (trigeminal neuralgia, Arnold neuralgia, etc.). * Being receiving therapy (except rescue pharmacological therapy) for this disorder or pain. * Cognitive impairment that prevents the follow-up of an educational program (determined through the MoCA questionnaire)
Where this trial is running
Valencia, Valencia
- Catholic Univerity of Valencia — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Marta M Martínez-Soler, Physiotherapist
- Email: marta.martinez@ucv.es
- Phone: +34 638 97 48 04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.