Clinical trial NCT06259344: Pain Science Education Administered in Full or Fractioned Dosage Modes for Temporomandibular Disorders
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Disorders
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 148
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental: Fractioned Pain Science Education (PSE) program + Manual Therapy + Orofacial and Neck Motor Exercises (ONE) (FPSE) Six sessions of 15 minutes each of a workshop on PSE will be administered. Two protocols of ONE and Manual Therapy (MT) and ONE will be administered. The exercises will be administered for six weeks, twice a week. Half of the sessions will include orofacial therapy and exercises and half neck motor control exercises. Each exercise and technique will be administered 10 times for 10 seconds.

Active Comparator: Full Dosage Mode PSE (FDPSE) + MT + ONE Two sessions of 45 minutes (90 minutes) of PSE will be administered. Two protocols of ONE and MT will be administered. The exercises will be administered for six weeks, twice a week. Half of the sessions will include orofacial therapy and exercises and half neck motor control exercises. Each exercise and technique will be administered 10 times for 10 seconds.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* age between 20 and 60 years;
* painful TMD (confirmed by applying DC/TMD);
* complaint of pain with a minimum intensity of 3 (on a scale of 0 to 10) present for at least 3 months;
* fluency to speak and understand Brazilian Portuguese (Mini Cog instrument to assess cognitive capacity and the Cloze Test to certify textual reading comprehension)

Exclusion Criteria:

* history of tumors in the orofacial region;
* central and peripheral neurological diseases;
* uncontrolled psychiatric illnesses;
* pregnant women;
* presence of toothache, neuralgia or chronic painful conditions in the head region, orofacial region or systemic pain (for example, fibromyalgia, osteoarthritis, osteoarthritis or rheumatological diseases);
* report of previous major surgeries in the craniofacial region, such as orthognathic surgeries, TMJ surgeries, or resulting from post-trauma corrections;
* history of major trauma involving the cervical or craniofacial region (facial trauma, whiplash injuries, etc.);
* individuals undergoing physiotherapeutic treatment up to 6 months before the start of this study.

Primary outcomes:
measure: Change in Pain intensity
timeFrame: Immediately after treatment, three-, six- and twelve- month follow-up
measure: Change in Orofacial Pain related Disability
timeFrame: Immediately after treatment, three-, six- and twelve- month follow-up
Secondary outcomes:
measure: Change in Pain-Related Self-efficacy
timeFrame: Immediately after treatment, three-, six- and twelve- month follow-up
measure: Change in Kinesiophobia
timeFrame: Immediately after treatment, three-, six- and twelve- month follow-up
measure: Change in Global Perceived Effect of Improvement
timeFrame: Immediately after treatment, three-, six- and twelve- month follow-up
measure: Status of Empathy with the care provider
timeFrame: Immediately after treatment
measure: Previous and acquired knowledge about pain neuroscience
timeFrame: Immediately after treatment, three-, six- and twelve- month follow-up
measure: Beliefs about pain
timeFrame: Immediately after treatment, three-, six- and twelve- month follow-up
measure: Previous and current exercise adherence behaviour
timeFrame: Immediately after treatment, three-, six- and twelve- month follow-up
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Federal University of São Carlos - Department of Physical Therapy
state: São Paulo
Study officials:
affiliation: Federal University of São Carlos - UFSCar
name: Thais Chaves, Ph.D
role: STUDY_CHAIR
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