Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders

NCT06502769 | Not Yet Recruiting

• 1 other identifier: Temporomandibular Disorders
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorder

Keywords

therapeutic exercise; pain neurophysiology; temporomandibular disorder

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  The intensity of pain will be evaluated using the Visual Analogue Scale that is represented by a 10cm line where the left end indicates "no pain" and the right end indicates "maximum pain".

  The scale will be passed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment.

Secondary Outcomes (6)

• Mouth opening without pain

  at baseline, immediately after treatment, 4 and 12 weeks after treatment.

• Orofacial disability and pain

  at baseline, immediately after treatment, 4 and 12 weeks after treatment.

• Catastrophism

  at baseline, immediately after treatment, 4 and 12 weeks after treatment.

• Kinesiophobia

  at baseline, immediately after treatment, 4 and 12 weeks after treatment.

• Pressure pain thresholds

  at baseline, immediately after treatment, 4 and 12 weeks after treatment.

Study Arms (2)

TE+PNE group

EXPERIMENTAL

patients with TMD who are going to combine therapeutic exercise with education in pain neurophysiology

Behavioral: Therapeutic Exercise; Behavioral: Pain Neurophysiology Education

TE group

OTHER

patients with TMD who are going to perform isolated therapeutic exercise

Behavioral: Therapeutic Exercise

Interventions

Therapeutic Exercise BEHAVIORAL

A therapeutic exercise program will be carried out

TE group; TE+PNE group

Pain Neurophysiology Education BEHAVIORAL

A PNE program will be carried out

TE+PNE group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Campus Científico Tecnológico UAH. AV. de León, 3A.

Alcalá de Henares, Madrid, 28804, Spain

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 29710099 BACKGROUND

• 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.

  PMID: 29138049 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• María Teresa Ortiz-Moreno, MSc

  University of Alcalá

  PRINCIPAL INVESTIGATOR

• Gema Bodes-Pardo, PhD

  University of Alcalá

  STUDY DIRECTOR

Central Study Contacts

María Teresa Ortiz-Moreno, MSc

CONTACT

+34662422993; teresa.ortizm@edu.uah.es

Gema Bodes-Pardo, PhD

CONTACT

gbodespardo@gmail.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: MSc

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)