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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Другое Manual Therapy
  Intraoral temporalis release, Intraoral medial and lateral pterygoid (origin) technique and Intraoral sphenopalatine ganglion technique.
• Другое 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 a

Первичные конечные точки

• Change in Pain intensity [Срок оценки: Immediately after treatment, three-, six- and twelve- month follow-up]
• Change in Orofacial Pain related Disability [Срок оценки: Immediately after treatment, three-, six- and twelve- month follow-up]

Вторичные конечные точки (7)

• Change in Pain-Related Self-efficacy [Срок оценки: Immediately after treatment, three-, six- and twelve- month follow-up]
• Change in Kinesiophobia [Срок оценки: Immediately after treatment, three-, six- and twelve- month follow-up]
• Change in Global Perceived Effect of Improvement [Срок оценки: Immediately after treatment, three-, six- and twelve- month follow-up]
• Status of Empathy with the care provider [Срок оценки: Immediately after treatment]
• Previous and acquired knowledge about pain neuroscience [Срок оценки: Immediately after treatment, three-, six- and twelve- month follow-up]
• Beliefs about pain [Срок оценки: Immediately after treatment, three-, six- and twelve- month follow-up]
• Previous and current exercise adherence behaviour [Срок оценки: Immediately after treatment, three-, six- and twelve- month follow-up]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Federal University of São Carlos - Department of Physical Therapy — São Carlos

Публикации

• 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
• 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
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• 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 (Ho PMID 22588748
• 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
• 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.202 PMID 35934276
• 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
• 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

Идентификаторы

NCT: NCT06259344 · 77273924.9.0000.5504

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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