Clinical Trials Logo
  1. Home
  2. Other
  3. NCT06259344

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

Temporomandibular Joint Disorders Clinical Trial

Official title:
Effect of Pain Science Education Administered in Full or Fractioned Dosage Modes Associated With Conventional Treatment on Pain Intensity and Disability for Temporomandibular Disorders: a Randomized Controlled Trial

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction Syndrome
Clinical Trial Details
NCT number NCT06259344
Study type Interventional
Source Universidade Federal de Sao Carlos
Contact Juliana Spavieri, MSc
Phone 05516 996092206
Email jspavieri@estudante.ufscar.br
Status Not yet recruiting
Phase N/A
Start date September 1, 2024
Completion date December 10, 2027
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03675659 - Intra-articular Magnesium Sulfate for Tmj Dysfunction Early Phase 1
Completed NCT05740826 - Correlation Between Cervical Spine Muscle Disorders and the Occurrence of Symptoms of Temporomandibular Joint Dysfunction
Recruiting NCT05006963 - Tele-Rehabilitation in Patients With Temporomandibular Dysfunction N/A
Active, not recruiting NCT06103851 - Effect of Mask Use on Jaw Functionality
Not yet recruiting NCT02908568 - Stimulation of the Proprioceptive Trigeminocardiac Reflex Phase 2/Phase 3
Completed NCT03119324 - Low Level Laser Therapy in the Treatment of Temporomandibular Joint Disorders (TMJDs) Related Pain N/A
Completed NCT02247063 - Motor Cortex as a Research & Therapeutic Target in TMD N/A
Recruiting NCT06046521 - Impact of Temporomandibular Joint Dysfunction on Objective and Subjective Vocal Measures
Completed NCT00009594 - Alternative Medicine Approaches for Women With Temporomandibular Disorders Phase 2
Completed NCT00010621 - Complementary Medicine Approaches to TMD Pain Management Phase 2
Completed NCT06055855 - Comparing Two-Needle vs. Surgery-Guided Arthrocentesis for TMJ Disorders N/A
Recruiting NCT06035341 - The Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction N/A
Completed NCT05821985 - Evaluation of the Effect of Dextrose Prolotherapy Versus Dry Needling Therapy N/A
Completed NCT06005922 - The Effectiveness of Temporomandibular Joint Mobilization and Exercise in Individuals With Chronic Neck Pain N/A
Completed NCT06034756 - Temporomandibular Joint Problems and Core Stabilization
Completed NCT03576079 - Effect of Laser Therapy Versus Anterior Re-positioning Splint in the Treatment of Disc Displacement With Reduction N/A
Completed NCT04557878 - Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction Phase 2
Completed NCT04477122 - Effects of Radial Shock Wave Therapy in the Treatment of Temporomandibular Joint Syndrome. N/A
Completed NCT00237042 - Managing Temporomandibular Disorder (TMD) Symptoms N/A
Completed NCT06132802 - Evaluation of Anterior Repositioning Guided Splint Combined With or Without I Platelet-rich Fibrin N/A