Actively Recruiting
Orofacial Pain Self-management: Personality Moderation Effect Randomized Clinical Trial
Led by Fundación Universidad Católica de Valencia San Vicente Mártir · Updated on 2025-12-08
98
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of a self-management program on pain perception in patients with chronic orofacial pain and temporomandibular disorders (TMD), comparing it with standard treatment based on clinical practice guidelines. It also studies how personality traits and psychosocial factors like stress perception and anxiety may influence treatment outcomes. The trial involves adults aged 18 to 65 diagnosed with TMD and chronic orofacial pain lasting more than three months. Participants will be randomly assigned to one of two groups. The experimental group will receive a self-management protocol including education, cognitive-behavioral tools, therapeutic exercises for the orofacial region, mind-body strategies, and lifestyle modifications, delivered over five sessions spanning 10 weeks. The control group will follow a clinical practice guideline intervention with five sessions of education, cognitive-behavioral techniques for bruxism, jaw exercises, and manual therapy over the same period. Participants will be assessed at three different times: before the intervention, after 5 weeks (post-treatment), and after 6 months. Various measures will be used, including pain scales (Visual Analogue Scale and Chronic Pain Grading Scale), questionnaires on catastrophizing, fear-avoidance, mandibular function, stress, anxiety, and personality, as well as physical assessments like mandibular opening and pressure algometry. Exercise session compliance and other psychosocial variables will also be monitored. The study includes statistical analysis to evaluate treatment effects and the role of personality on outcomes.
CONDITIONS
Brief Title
Orofacial Pain Self-management: Personality Moderation Effect
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of temporomandibular disorders (TMD) according to CD/TMD classification
- Age between 18 and 65 years
- Presence of pain in mandibular, temporal, facial, peri-auricular, and/or auricular regions
- Chronic orofacial pain lasting more than two hours a day for at least half of the days during the last three months
- Orofacial pain related to TMD according to International Classification of Headaches
- Moderate pain intensity with a weekly average of at least 30 mm on a 100 mm Visual Analogue Scale
You will not qualify if you...
- Rheumatic systemic diseases
- History of trauma or recent surgery in the head, face, neck, or chest
- Presence of intraoral infections or odontogenic pain
- Neuropathic headaches such as trigeminal neuralgia or Arnold neuralgia
- Currently receiving therapy for TMD or pain, except rescue medication
- Cognitive impairment preventing participation in educational programs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants receive either a self-management intervention or a clinical practice guideline-based intervention. Both interventions consist of 5 sessions over 10 weeks, focusing on education, cognitive behavioural tools, exercises, and other therapeutic strategies to manage chronic orofacial pain.
5 sessions spaced every two weeks
Duration - 6 months after treatment
Participants attend evaluation sessions to assess pain perception and other psychosocial and functional variables at pre-intervention, post-5 weeks, and post-6 months.
3 evaluation sessions (pre-intervention, post-5 weeks, post-6 months)
Trial Site Locations
Total: 1 location
1
Catholic Univerity of Valencia
Valencia, Valencia, Spain, 46001
Actively Recruiting
Research Team
M
Marta M Martínez-Soler, Physiotherapist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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