Clinical trial NCT06502769: Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders
Official title: Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders: a Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Temporomandibular Disorder
Keywords: therapeutic exercise
pain neurophysiology
temporomandibular disorder
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain intensity
timeFrame: The scale will be passed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment.
Secondary outcomes:
measure: Mouth opening without pain
timeFrame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
measure: Orofacial disability and pain
timeFrame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
measure: Catastrophism
timeFrame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
measure: Kinesiophobia
timeFrame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
measure: Pressure pain thresholds
timeFrame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
measure: Self-Perception of Improvement
timeFrame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Campus Científico Tecnológico UAH. AV. de León, 3A.
state: Madrid
Study officials:
affiliation: University of Alcalá
name: María Teresa Ortiz-Moreno, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alcalá
name: Gema Bodes-Pardo, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.