NCT06502769

Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Alcala · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Temporomandibular Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Therapeutic Exercise	A therapeutic exercise program will be carried out
BEHAVIORAL	Pain Neurophysiology Education	A PNE program will be carried out

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-07-31
• Completion: 2026-09-30
• First posted: 2024-07-16
• Last updated: 2024-07-16

Locations

1 site across 1 country: Spain