Pain Science Education Administered in Full or Fractioned Dosage Modes for Temporomandibular Disorders

Summary

Temporomandibular Disorders (TMD) are a collection of musculoskeletal disorders which affect the masticatory structures and have a multifactorial etiology. A biopsychosocial approach is recommended for the management of these disorders including different interventions like exercise, manual therapy and pain education. The aim of this study is to compare the effect of a full dosage mode pain science education program (2 initial sessions of 45 minutes) versus a fractioned dosage format (6 sessions of 15 minutes) combined with manual therapy and orofacial exercises on primary outcomes - pain intensity and disability - and secondary outcomes - mandibular range of motion, pain-related self-efficacy, kinesiophobia, global perception of improvement, empathy, knowledge about pain neuroscience, beliefs about pain, exercise adherence, and catastrophizing - in patients with chronic painful TMD. This study will be a randomized controlled trial with a sample of 148 participants. Individuals will undergo a screening process to identify those with TMD diagnosis according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), aged 20 to 60 years, of both genders, and then the volunteers will be randomized into two groups (G1: Full dosage mode pain science education program + Manual therapy/orofacial and neck motor exercises vs. G2: Fractioned dosage mode pain science education program + Manual therapy/orofacial and neck motor exercises). These volunteers will be recruited in the city of São Carlos, SP. The intervention will take place twice a week for 8 weeks, administered by a single therapist, each session lasting 1 hour. The primary outcomes will be pain intensity and disability, assessed using the numerical pain rating scale and the Craniofacial Pain and Disability Inventory (CFP-DI), respectively, and the secondary outcomes will be mandibular range of motion, pain-related self-efficacy, kinesiophobia, global perception of improvement, empathy, knowledge about pain neuroscience, beliefs about pain, exercise adherence, and catastrophizing, assessed using the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD), Global Perceived Effect of Improvement scale, Pain Self-Efficacy Questionnaire (PSEQ), CARE Empathy Scale, and Pain Catastrophizing Scale (PCS). For statistical analysis, a Generalized Estimated Equations considering time and groups as factors will be used. A significance level of p\<0.05 will be considered.

Conditions

• Temporomandibular Joint Disorders

Interventions

BEHAVIORAL

Fractioned Pain Science Education (FPSE)

Pain Science Education (PSE) will be administered in workshop sessions with interactive presentations, using different resources as metaphors and videos. It will be held in 2 sessions of 45 minutes each, covering 6 topics of Explain Pain and Explain Pain Supercharged books.

BEHAVIORAL

Full Dosage Mode Pain Science Education (FDPSE)

Pain Science Education (PSE) will be administered in workshop sessions with interactive presentations, using different resources as metaphors and videos. It will be held in 6 sessions of 15 minutes each, covering 6 topics of Explain Pain and Explain Pain Supercharged books.

OTHER

Manual Therapy

Intraoral temporalis release, Intraoral medial and lateral pterygoid (origin) technique and Intraoral sphenopalatine ganglion technique.

OTHER

Orofacial and Neck Exercises (ONE)

Orofacial Exercises: Mandibular body-condylar cross-pressure chewing technique; Post-isometric relaxation stretches-laterotrusion and opening (10 times/session; 10 seconds). Neck Motor Control Exercises: Bracing exercises (6 hierarchical levels - HL). Extreme range of motion exercises (stable spine). Cervical isometric exercises (5 HL) directly forward, obliquely, toward right and left, and directly backward (stable spine - elastic resistive bands). Functional training with elastic resistance and exercise balls on unstable surfaces (8 HJ). The progress in each exercise domain will happen when sustaining the contraction for 10 seconds, 10 times.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos

  lead OTHER

Principal Investigators

• Thais Chaves, Ph.D · Federal University of São Carlos - UFSCar

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2027-12-10

Completion

2027-12-10

Countries

• Brazil

Study Locations