Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders

Официальное название

Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders: a Single-blind Randomized Controlled Trial

Обзор

The aim of this study is to compare the effects in pain of two different treatments in pacients with temporomandibular disorders (TMD). One group will receive isolated therapeutic exercise (TE) and the other will receive TE combined with pain neurophysiology education (PNE). The hypothesis of this study is that the PNE+TE group will obtain superior therapeutic results than an isolated TE program.

Подробное описание

Objective: To evaluate the differences in pain intensity by performing isolated therapeutic exercise (TE) versus performing the same exercise combined with pain neurophysiology education (PNE) in patients with temporomandibular disorders (TMD).

Design: Single-blind randomized controlled trial. Setting: Faculty of Physical Therapy of Alcalá de Henares. Participants: Subjects with TMD lasting more than 6 months (N= 36). Interventions: Participants will be randomly assigned to receive a TE program consisting of stretching, coordination and strengthening exercises (n= 18) or the same TE program in addition to a PNE program (n= 18), performed in two sessions of 40 minutes in groups of 6 participants. The intervention will last 12 weeks, where all participants must complete the exercise program daily, one year later they will be evaluated again.

Main outcome measures: The primary outcome will be pain intensity through the visual analogue scale (VAS) which will be completed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment. Secondary outcome measures include pain-free mouth opening, Craniofacial Pain and Disability Inventory (CF-PDI), Pain Catastrophizing Scale (PCS), Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-11), pressure pain thresholds (PPT) and Patient Global Impression of Change (PGIC). They will be recorded through blinded assessments performed by 2 physiotherapists at baseline, immediately after treatment, 4 and 12 weeks after treatment. Student's t test will be used to determine differences between group interventions.

Вмешательства

• Поведенческое Therapeutic Exercise
  A therapeutic exercise program will be carried out
• Поведенческое Pain Neurophysiology Education
  A PNE program will be carried out

Первичные конечные точки

• Pain intensity [Срок оценки: The scale will be passed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment.]

Вторичные конечные точки (6)

• Mouth opening without pain [Срок оценки: at baseline, immediately after treatment, 4 and 12 weeks after treatment.]
• Orofacial disability and pain [Срок оценки: at baseline, immediately after treatment, 4 and 12 weeks after treatment.]
• Catastrophism [Срок оценки: at baseline, immediately after treatment, 4 and 12 weeks after treatment.]
• Kinesiophobia [Срок оценки: at baseline, immediately after treatment, 4 and 12 weeks after treatment.]
• Pressure pain thresholds [Срок оценки: at baseline, immediately after treatment, 4 and 12 weeks after treatment.]
• Self-Perception of Improvement [Срок оценки: at baseline, immediately after treatment, 4 and 12 weeks after treatment.]

Критерии участия

Критерии включения

• Over 18 years of age
• Limitation of mouth opening and/or jaw pain lasting more than 6 months
• Being able to understand the objective and carry out the study procedures
• Sign the informed consent.

Критерии исключения

• Suffer from any underlying disease
• Pain due to tumors or infections, metastases, osteoporosis, inflammatory arthritis or fractures
• Be receiving any other treatment for TMD or consuming some type of substance that alters muscle tone.
• Patients with myopathies, diseases of the Peripheral Nervous System, mental disorders diagnosed by a doctor
• Inability to collaborate
• Any other situation in which the evaluation could be altered.

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

Испания · 1 центр

• Campus Científico Tecnológico UAH. AV. de León, 3A. — Alcalá de Henares

Публикации

• Calixtre LB, Gruninger BL, Haik MN, Alburquerque-Sendin F, Oliveira AB. Effects of cervical mobilization and exercise on pain, movement and function in subjects with temporomandibular disorders: a single group pre-post test. J Appl Oral Sci. 2016 May-Jun;24(3):188-97. doi: 10.1590/1678-775720150240. PMID 27383698
• Chellappa D, Thirupathy M. Comparative efficacy of low-Level laser and TENS in the symptomatic relief of temporomandibular joint disorders: A randomized clinical trial. Indian J Dent Res. 2020 Jan-Feb;31(1):42-47. doi: 10.4103/ijdr.IJDR_735_18. PMID 32246680
• Sousa BM, Lopez-Valverde N, Lopez-Valverde A, Caramelo F, Fraile JF, Payo JH, Rodrigues MJ. Different Treatments in Patients with Temporomandibular Joint Disorders: A Comparative Randomized Study. Medicina (Kaunas). 2020 Mar 5;56(3):113. doi: 10.3390/medicina56030113. PMID 32151101
• Dos Santos Aguiar A, Bataglion C, Felicio LR, Azevedo B, Chaves TC. Additional effect of pain neuroscience education to craniocervical manual therapy and exercises for pain intensity and disability in temporomandibular disorders: a study protocol for a randomized controlled trial. Trials. 2021 Sep 6;22(1):596. doi: 10.1186/s13063-021-05532-x. PMID 34488856
• Wanman A, Marklund S. Treatment outcome of supervised exercise, home exercise and bite splint therapy, respectively, in patients with symptomatic disc displacement with reduction: A randomised clinical trial. J Oral Rehabil. 2020 Feb;47(2):143-149. doi: 10.1111/joor.12888. Epub 2019 Sep 30. PMID 31520538
• Yamaguchi Y, Sakuma S, Takagi S, Ogi N, Kurita K, Ariji Y, Taguchi N. Efficacy of therapeutic exercise for temporomandibular disorders as assessed by magnetic resonance imaging: a case report. J Phys Ther Sci. 2020 Jul;32(7):477-482. doi: 10.1589/jpts.32.477. Epub 2020 Jul 3. PMID 32753791
• Garrigos-Pedron M, La Touche R, Navarro-Desentre P, Gracia-Naya M, Segura-Orti E. Effects of a Physical Therapy Protocol in Patients with Chronic Migraine and Temporomandibular Disorders: A Randomized, Single-Blinded, Clinical Trial. J Oral Facial Pain Headache. 2018 Spring;32(2):137-150. doi: 10.11607/ofph.1912. PMID 29694464
• Michelotti A, de Wijer A, Steenks M, Farella M. Home-exercise regimes for the management of non-specific temporomandibular disorders. J Oral Rehabil. 2005 Nov;32(11):779-85. doi: 10.1111/j.1365-2842.2005.01513.x. PMID 16202040

Идентификаторы

NCT: NCT06502769 · Temporomandibular Disorders

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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