Orofacial Pain Self-management: Personality Moderation Effect
Orofacial Pain Self-management: Personality Moderation Effect - Randomized Clinical Trial
Fundación Universidad Católica de Valencia San Vicente Mártir
98 participants
Nov 28, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria6
- 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)
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Interventions
This intervention will implement a self-management protocol. It will consist in 5 strategy levels: educational concepts and dynamics, cognitive behavioural tools and processes, therapeutic exercise of the orofacial region, guidelines and strategies for lifestyle modification and mindbody tools. Several of the above 5 strategies will be employed in each session. Education will include TMD concepts, pain neurophysiology, contextualisation of pain in terms of perceived stress, anxiety and others. Exercises will aim to train motor control, strength and mobility. Cognitive behavioural tools will be used to modulate pain relationship through behaviour modification. Processes such as cognitive distraction, gradual exposure to movement or the scheduling of self-care activities will be used. Mindbody strategies such as relaxation exercises and pain acceptance will seek to reduce the patient's frustration with pain. Structured guidelines will be included to achieve desirable lifestyle changes.
Following the guidelines, 5 sessions of education, cognitive behavioural tools, jaw exercises and manual therapy will be conducted. The educational sessions will teach about TMD and basic pain concepts. A single type of cognitive behavioural tool will be employed. The aim will be to decrease bruxing and parafunctional activity during wakefulness. This will be done by training the jaw relaxation position, which will then be generalised to activities of daily living with the help of some conditioning through positive and negative reinforcement. Exercise activities will aim to train motor control, strength and mobility. Manual therapy will be carried out in the orofacial region by means of soft tissue techniques and joint mobilisation.
Locations(1)
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NCT06932406