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Clinical Trials in Spain / NCT07056725
Starting soon Not applicable

Quality of Life and Sleep in Patients With Temporomandibular Disorders

NCT07056725 · tracked via the Priya Life Science Spain tracker
Sponsor
University of Jaén
Phase
Not applicable
Started
2025-08
Last updated
2025-07-09

Condition(s) studied

Temporomandibular Disorders (TMDs)

Investigational drug(s) / intervention(s)

Manual Therapy and Therapeutic Exercises Programs

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Adults between 18 and 65 years of age with subacute Temporomandibular Disorders (TMD). * Diagnosis of TMD based on: The Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). And The Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). * Willingness to participate in the study and signing of the informed consent form. Exclusion Criteria: * Individuals younger than 18 years or older than 65 years. * Medical history or systemic conditions, including: Diagnosis of neurological or neuromuscular disorders (such as multiple sclerosis, facial paralysis, trigeminal neuralgia). Systemic or inflammatory joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia). Presence of severe psychiatric disorders. Previous diagnosis of cancer in the craniofacial or cervical region. * Previous interventions (e.g., surgery involving the TMJ or the orofacial and cervical regions). * History of trauma in the region, including mandibular trauma, whiplash injuries, or fractures in the area. * Pregnant or breastfeeding women.

Primary outcome measure(s)

  • Quality of Life (SF-12) — Pre-intervention, post-intervention (6 weeks) and follow-up of 8 weeks after the end
    The SF-12 consists of a subset of 12 items from the SF-36, covering physical functioning, social functioning, physical role, emotional role, mental health, vitality, bodily pain, and general health. The SF-12 is a shortened version of the SF-36 Health Survey. It is a self-administered questionnaire with a completion time of less than 2 minutes. The response options are based on Likert-type scales that assess intensity or frequency. The number of response options ranges from three to six, depending on the item.
  • Sleep Quality (Pittsburgh Sleep Quality Index) — Pre- intervation, post-intervention (6 weeks) and follow-up of 8 weeks after the end.
    The Pittsburgh Sleep Quality Index (PSQI) is a self-administered instrument designed to assess sleep quality in adults over the past month. It consists of 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.

Trial sites (1)

FacilityCityRegionStatus
Universidad de Alcalá De Henares Madrid Alcalá de Henares

More University of Jaén trials in Spain

Effectiveness of a Prehabilitation Program for Hip or Knee Arthroplasty Surgery. Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07056725 on ClinicalTrials.gov ↗ ← All trials in Spain