NCT07056725

Quality of Life and Sleep in Patients With Temporomandibular Disorders

Quality of Life and Sleep in Patients With Temporomandibular Disorders. A Protocol for a Randomized Control Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Jaén · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate and compare the effects of two physiotherapeutic intervention programs on the quality of life in patients with Temporomandibular Disorders (TMD). Study design: Randomized, longitudinal, and prospective clinical trial with two intervention groups. Population: Subjects aged 18-65 years with subacute temporomandibular disorders.

Detailed description

The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. A total of 30 subjects with Temporomandibular Disorders (TMD) will be selected and randomly assigned into two intervention groups. The first group will receive a physiotherapy treatment based on a Manual Therapy program targeting the orofacial region, combined with a Cervical Therapeutic Exercise program. In contrast, the second group will receive a physiotherapy treatment based on a Manual Therapy program for the orofacial region, combined with an Orofacial Therapeutic Exercise program. Both groups will undergo a total of six treatment sessions over a period of six weeks (1 session per week). Each manual therapy session targeting the orofacial region will last 30 minutes. The manual therapy (MT) techniques will include a combination of neuromuscular and articular manual techniques. The study will assess the following variables: quality of life, sleep quality, pressure pain threshold, maximum pain-free mouth opening, perceived pain, and treatment adherence. Measurements will be taken pre-treatment, post-treatment and a follow-up at 8 weeks

Conditions

• Temporomandibular Disorders (TMDs)

Interventions

Type	Name	Description
OTHER	Manual Therapy and Therapeutic Exercises Programs	A treatment based on the combination of Manual Therapy targeting the orofacial region and a therapeutic exercise program focused on either the cervical or orofacial region

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-10-01
• Completion: 2026-01-01
• First posted: 2025-07-09
• Last updated: 2025-07-09

Locations

1 site across 1 country: Spain