Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders
NCT ID: NCT06502769
Last Updated: 2024-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
36 participants
INTERVENTIONAL
2024-09-01
2026-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TE+PNE group
patients with TMD who are going to combine therapeutic exercise with education in pain neurophysiology
Therapeutic Exercise
A therapeutic exercise program will be carried out
Pain Neurophysiology Education
A PNE program will be carried out
TE group
patients with TMD who are going to perform isolated therapeutic exercise
Therapeutic Exercise
A therapeutic exercise program will be carried out
Interventions
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Therapeutic Exercise
A therapeutic exercise program will be carried out
Pain Neurophysiology Education
A PNE program will be carried out
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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University of Alcala
OTHER
Responsible Party
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María Teresa Ortiz Moreno
MSc
Principal Investigators
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María Teresa Ortiz-Moreno, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Alcalá
Gema Bodes-Pardo, PhD
Role: STUDY_DIRECTOR
University of Alcalá
Locations
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Campus Científico Tecnológico UAH. AV. de León, 3A.
Alcalá de Henares, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Malfliet A, Kregel J, Coppieters I, De Pauw R, Meeus M, Roussel N, Cagnie B, Danneels L, Nijs J. Effect of Pain Neuroscience Education Combined With Cognition-Targeted Motor Control Training on Chronic Spinal Pain: A Randomized Clinical Trial. JAMA Neurol. 2018 Jul 1;75(7):808-817. doi: 10.1001/jamaneurol.2018.0492.
Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.
Other Identifiers
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Temporomandibular Disorders
Identifier Type: -
Identifier Source: org_study_id
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