Orofacial Pain Self-management: Personality Moderation Effect

NCT06932406 | Recruiting DMC

• 1 other identifier: UCV/2023-2024/072
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Dysfunction (TMD); Chronic Orofacial Pain; Temporomandibular Disorder (TMD); Temporomandibular Disorders (TMD)

Keywords

Temporomandibular disorder; Orofacial pain; Self-management; self-efficacy; therapeutic exercise; therapeutic education; cognitive behavioral; mind-body techniques; Lifestyle modification training; manual therapy; personality; psychosocial; biopsychosocial; physiotherapy

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale (VAS)

  Pain intensity assessment instrument consisting of a 10-centimetre horizontal line numbered from 0 to 10, where 0 represents no pain and 10 represents the greatest unimaginable pain. The patient must mark on the line the point that indicates the intensity of his or her pain and then it is measured with a millimetre ruler. The intensity is expressed in centimetres or millimetres. If reporting a score on this scale, it is important to include the minimum and maximum values (0 and 10, respectively), as well as clarify that higher scores represent worse pain intensity. This tool has a high reliability, with an Internal Consistency (IC) of 0.97.

  It will be used in the pre-intervention, post-5 weeks and post-6 months analyses.

• Chronic Pain Grading Scale 2.0 Spanish Version (GCPS)

  Quantitative assessment scale of chronic pain that evaluates the degree of pain using 8 items, quantifying the number of days of pain in the last 6 months, current pain, average and maximum monthly pain and pain and limitation in ADL, social and occupational activities. Each item measures the score on an 11-point Likert scale, with a total range from 0 to 70 points. The tool has an internal consistency, represented by Cronbach's α coefficient, of 0.87 (95% CI, 0.83-0.92). If reporting a score on this scale, it is important to include the minimum and maximum values (0 and 70, respectively), as well as clarify that higher scores represent worse outcomes.

  It will be used in the pre-intervention, post-5 weeks and post-6 months analyses.

Secondary Outcomes (15)

• Demographic data

  These data will be collected pre-intervention.

• Pain Catastrophizing Scale (PCS)

  It will be used in the pre-intervention, post-5 weeks and post-6 months analyses.

• The Tampa Scale of Kinesiophobia for Temporomandibular Disorders Versión Español (TSK11-TMD-S)

  It will be used in pre-intervention, post-5 weeks and post-6 months analyses.

• Fear-Avoidance Beliefs Questionnaire (FABQ)

  It will be used in the pre-intervention, post-5 weeks and post-6 months analyses.

• The Mandibular Function Impairment Questionnaire (MFIQ)

  It will be used in the pre-intervention, post-5 weeks and post-6 months analyses.

Other Outcomes (3)

• Treatment adherence

  This variable will be collected post 5 weeks and reviewed during the treatment.this variable will not be used in this disc analysis

• Montreal Cognitive Assessment Test (MoCA Test)

  This variable will be collected pre-intervention as a measure to objectify the absence of cognitive impairment and to justify the part related to cognitive abilities that allow the patient to be included in the study. It will not be treated for statistic

• Self-reporting of educational level

  This variable will be collected at the pre intervention time.

Study Arms (2)

Self-management Group

EXPERIMENTAL

This group will implement a protocol based on self-management consisting of 5 levels of strategy: educational concepts and dynamics, cognitive behavioural tools, therapeutic exercise of the orofacial region, guidelines and strategies for lifestyle modification and mindbody tools. This protocol was developed by conducting a previous Scoping Review abouts application methods of selfmanagement in orofacial region. The intervention will be carried out in 5 total sessions of 45-60 minutos over 10 weeks.

Other: Self-management intervention

Clinical Practice Guideline Group

ACTIVE COMPARATOR

The protocol will be based on the Clinical Practice Guideline for the Management of Temporomandibular Disorders 2021. Following the guideline, there will be 5 sessions of pathology and pain education, cognitive behavioural tools for bruxism and parafunctional habits, jaw exercises for motor control, mobility and strength, and manual therapy. The intervention will be carried out in 5 total sessions of 45-60 minutos over 10 weeks.

Other: Clinical Practice Guideline Intervention

Interventions

Self-management intervention OTHER

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.

Also known as: GSelf-Management, GS-M

Self-management Group

Clinical Practice Guideline Intervention OTHER

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.

Also known as: GClinical Practice Guideline, GCPG

Clinical Practice Guideline Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (1)

Catholic Univerity of Valencia

Valencia, Valencia, 46001, Spain

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marta M Martínez-Soler, Physiotherapist

CONTACT

+34 638 97 48 04; marta.martinez@ucv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, longitudinal, comparative randomized clinical trial (RCT) will be conducted. The sample will be composed of adults with chronic orofacial pain who meet the inclusion and exclusion criteria of the study. Three measurements will be performed: pre-intervention, post-5 weeks and post-6 months. The study is based on the principles of the 2017 Declaration of Helsinki, all participants will be informed at all times and prior to study participation will be required to sign informed consent. The intervention design has been designed based on the CONSORT Guidelines for Randomised Clinical Trials and will be registered on ClinicalTrials.gov.

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): May 24, 2026
• Study Completion (Estimated): May 24, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-01

Locations

ES (1)