Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders

University of Alcala

Status: Not yet enrolling

Conditions: Temporomandibular Disorder

Treatments: Behavioral: Therapeutic Exercise; Behavioral: Pain Neurophysiology Education

Study type: Interventional

Funder types: Other

Identifiers

NCT06502769

Temporomandibular Disorders

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

TE+PNE group

Experimental group

Description:

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

Treatment:

Behavioral: Pain Neurophysiology Education

Behavioral: Therapeutic Exercise

TE group

Other group

Description:

patients with TMD who are going to perform isolated therapeutic exercise

Treatment:

Behavioral: Therapeutic Exercise