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

NCT06259344 | Not Yet Recruiting

• 1 other identifier: 77273924.9.0000.5504
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (2)

• Change in Pain intensity

  The Numerical Pain Rating Scale will be used to assess pain intensity in this trial. It consists of a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable".

  Immediately after treatment, three-, six- and twelve- month follow-up

• Change in Orofacial Pain related Disability

  The Craniofacial Pain and Disability Inventory (CF-PDI) is a self-administered questionnaire that measures the outcomes of pain and disability related to craniofacial pain. It demonstrated a good structure, internal consistency, reproducibility, and construct validity. Also, the Brazilian Portuguese version showed acceptable psychometric measurements. It consists of 21 items, with a score ranging from 0 to 63 points. Each question is scored on a 4-point ordinal scale, ranging from 0 to 3. A higher score reflects higher disability levels.

  Immediately after treatment, three-, six- and twelve- month follow-up

Secondary Outcomes (7)

• Change in Pain-Related Self-efficacy

  Immediately after treatment, three-, six- and twelve- month follow-up

• Change in Kinesiophobia

  Immediately after treatment, three-, six- and twelve- month follow-up

• Change in Global Perceived Effect of Improvement

  Immediately after treatment, three-, six- and twelve- month follow-up

• Status of Empathy with the care provider

  Immediately after treatment

• Previous and acquired knowledge about pain neuroscience

  Immediately after treatment, three-, six- and twelve- month follow-up

Study Arms (2)

Fractioned Pain Science Education + Manual Therapy + Orofacial and Neck Exercises

ACTIVE COMPARATOR

All participants in this arm will initially receive six sessions in which a workshop on PSE will be administered and discussed. A power-point presentation with metaphors and animated videos will be employed. The PSE program will be held in 6 sessions of 15 minutes each. Two protocols of Orofacial Exercises and Manual Therapy and of Neck Motor Control will be adopted in the present study. The exercises will be administered during six weeks, twice a week. One session will run in the outpatient clinic and the other will be home based. Half of the sessions will consist of orofacial therapy and exercises and the other half neck motor control exercises. Each exercise and technique will be administered 10 times for 10 seconds.

Behavioral: Fractioned Pain Science Education (FPSE); Other: Manual Therapy; Other: Orofacial and Neck Exercises (ONE)

Full Dosage Pain Science Education + Manual Therapy + Orofacial and Neck Exercises

EXPERIMENTAL

All participants in this arm will initially receive two sessions in which a workshop on PSE will be administered and discussed. A power-point presentation with metaphors and animated videos will be employed. The PSE program will be held in 2 sessions of 45 minutes each one. Two protocols of Orofacial Exercises and Manual Therapy and of Neck Motor Control will be adopted in the present study. The exercises will be administered during six weeks, twice a week. One session will run in the outpatient clinic and the other will be home based. Half of the sessions will consist of orofacial therapy and exercises and the other half neck motor control exercises. Each exercise and technique will be administered 10 times for 10 seconds.

Behavioral: Full Dosage Mode Pain Science Education (FDPSE); Other: Manual Therapy; Other: Orofacial and Neck Exercises (ONE)

Interventions

Fractioned Pain Science Education (FPSE) BEHAVIORAL

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.

Fractioned Pain Science Education + Manual Therapy + Orofacial and Neck Exercises

Full Dosage Mode Pain Science Education (FDPSE) BEHAVIORAL

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.

Full Dosage Pain Science Education + Manual Therapy + Orofacial and Neck Exercises

Manual Therapy OTHER

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

Fractioned Pain Science Education + Manual Therapy + Orofacial and Neck Exercises; Full Dosage Pain Science Education + Manual Therapy + Orofacial and Neck Exercises

Orofacial and Neck Exercises (ONE) OTHER

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.

Fractioned Pain Science Education + Manual Therapy + Orofacial and Neck Exercises; Full Dosage Pain Science Education + Manual Therapy + Orofacial and Neck Exercises

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (1)

Federal University of São Carlos - Department of Physical Therapy

São Carlos, São Paulo, 13565-905, Brazil

Location

Related Publications (13)

• Aguiar ADS, Moseley GL, Bataglion C, Azevedo B, Chaves TC. Education-Enhanced Conventional Care versus Conventional Care Alone for Temporomandibular Disorders: A Randomized Controlled Trial. J Pain. 2023 Feb;24(2):251-263. doi: 10.1016/j.jpain.2022.09.012. Epub 2022 Oct 8.

  PMID: 36220481 BACKGROUND

• Calixtre LB, Moreira RF, Franchini GH, Alburquerque-Sendin F, Oliveira AB. Manual therapy for the management of pain and limited range of motion in subjects with signs and symptoms of temporomandibular disorder: a systematic review of randomised controlled trials. J Oral Rehabil. 2015 Nov;42(11):847-61. doi: 10.1111/joor.12321. Epub 2015 Jun 7.

  PMID: 26059857 BACKGROUND

• Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.

  PMID: 15621359 BACKGROUND

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

  PMID: 22588748 BACKGROUND

• Herrera-Valencia A, Ruiz-Munoz M, Martin-Martin J, Cuesta-Vargas A, Gonzalez-Sanchez M. Effcacy of Manual Therapy in TemporomandibularJoint Disorders and Its Medium-and Long-TermEffects on Pain and Maximum Mouth Opening:A Systematic Review and Meta-Analysis. J Clin Med. 2020 Oct 23;9(11):3404. doi: 10.3390/jcm9113404.

  PMID: 33114236 BACKGROUND

• Leake HB, Mardon A, Stanton TR, Harvie DS, Butler DS, Karran EL, Wilson D, Booth J, Barker T, Wood P, Fried K, Hayes C, Taylor L, Macoun M, Simister A, Moseley GL, Berryman C. Key Learning Statements for Persistent Pain Education: An Iterative Analysis of Consumer, Clinician and Researcher Perspectives and Development of Public Messaging. J Pain. 2022 Nov;23(11):1989-2001. doi: 10.1016/j.jpain.2022.07.008. Epub 2022 Aug 4.

  PMID: 35934276 BACKGROUND

• Maixner W, Diatchenko L, Dubner R, Fillingim RB, Greenspan JD, Knott C, Ohrbach R, Weir B, Slade GD. Orofacial pain prospective evaluation and risk assessment study--the OPPERA study. J Pain. 2011 Nov;12(11 Suppl):T4-11.e1-2. doi: 10.1016/j.jpain.2011.08.002. No abstract available.

  PMID: 22074751 BACKGROUND

• Moseley GL, Butler DS. Fifteen Years of Explaining Pain: The Past, Present, and Future. J Pain. 2015 Sep;16(9):807-13. doi: 10.1016/j.jpain.2015.05.005. Epub 2015 Jun 5.

  PMID: 26051220 BACKGROUND

• Romm MJ, Ahn S, Fiebert I, Cahalin LP. A Meta-Analysis of Therapeutic Pain Neuroscience Education, Using Dosage and Treatment Format as Moderator Variables. Pain Pract. 2021 Mar;21(3):366-380. doi: 10.1111/papr.12962. Epub 2020 Nov 22.

  PMID: 33131210 BACKGROUND

• Salazar-Mendez J, Nunez-Cortes R, Suso-Marti L, Ribeiro IL, Garrido-Castillo M, Gacitua J, Mendez-Rebolledo G, Cruz-Montecinos C, Lopez-Bueno R, Calatayud J. Dosage matters: Uncovering the optimal duration of pain neuroscience education to improve psychosocial variables in chronic musculoskeletal pain. A systematic review and meta-analysis with moderator analysis. Neurosci Biobehav Rev. 2023 Oct;153:105328. doi: 10.1016/j.neubiorev.2023.105328. Epub 2023 Jul 27.

  PMID: 37516218 BACKGROUND

• Slade GD, Ohrbach R, Greenspan JD, Fillingim RB, Bair E, Sanders AE, Dubner R, Diatchenko L, Meloto CB, Smith S, Maixner W. Painful Temporomandibular Disorder: Decade of Discovery from OPPERA Studies. J Dent Res. 2016 Sep;95(10):1084-92. doi: 10.1177/0022034516653743. Epub 2016 Jun 23.

  PMID: 27339423 BACKGROUND

• Watson JA, Ryan CG, Cooper L, Ellington D, Whittle R, Lavender M, Dixon J, Atkinson G, Cooper K, Martin DJ. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019 Oct;20(10):1140.e1-1140.e22. doi: 10.1016/j.jpain.2019.02.011. Epub 2019 Mar 1.

  PMID: 30831273 BACKGROUND

• Spavieri JHP, de Lima TC, Pereira RBR, Chaves TC. Effect of pain science education administered condensed or longitudinally associated with manual therapy and exercises on pain intensity and disability for Temporomandibular Disorders: a randomized controlled trial. Trials. 2025 Dec 18. doi: 10.1186/s13063-025-09320-9. Online ahead of print.

  PMID: 41413604 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Thais Chaves, Ph.D

  Federal University of São Carlos - UFSCar

  STUDY CHAIR

Central Study Contacts

Juliana Spavieri, MSc

CONTACT

05516 996092206; jspavieri@estudante.ufscar.br

Luiz Ricardo Garcês, MSc

CONTACT

luizgarcez07@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 10, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)