NCT06932406 Orofacial Pain Self-management: Personality Moderation Effect
| NCT ID | NCT06932406 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Universidad Católica de Valencia San Vicente Mártir |
| Condition | Chronic Orofacial Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2025-11-28 |
| Primary Completion | 2026-05-24 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The objective of this clinical trial is to study the effect of self-management on pain perception in patients with chronic orofacial pain and temporomandibular disorders (TMD) comparing it with the conventional treatment proposed by the TMD clinical practice guidelines. It also evaluates its effect on function and various psychosocial variables. As a secondary objective, this work proposes to study the variability between patients, in terms of personality factors, as moderators of the effect of treatment on pain perception. Including in the proposed statistical models certain covariates such as perception and/or coping with stress, anxiety and other psychosocial variables. This is a randomized clinical trial with two intervention groups and three measurement times (T0; pre-intervention, T1; post-5 weeks and T2; post-6 months). The experimental group will be applied a protocol based on self-management, which includes: therapeutic education, cognitive-behavioral tools, therapeutic exercise of the temporomandibular region, mind-body strategies and modifications of aspects related to lifestyle. The control group will carry out an intervention program based on the Clinical Practice Guidelines for the Management of Temporomandibular Joint Disorders. Therefore, using a set of tools based on therapeutic education, cognitive-behavioral tools for bruxism and other parafunctional habits, temporomandibular region exercises and manual therapy.
Eligibility 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 pharmacologic