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Not yet recruiting NCT07056725

Quality of Life and Sleep in Patients With Temporomandibular Disorders

No phase Interventional Temporomandibular Disorders (TMDs)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Manual Therapy and Therapeutic Exercises Programs.
Who it may be relevant to
Registry conditions: Temporomandibular Disorders (TMDs). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • 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

Primary outcome measures

  • Quality of Life (SF-12) [Time frame: Pre-intervention, post-intervention (6 weeks) and follow-up of 8 weeks after the end]
  • Sleep Quality (Pittsburgh Sleep Quality Index) [Time frame: Pre- intervation, post-intervention (6 weeks) and follow-up of 8 weeks after the end.]
Secondary outcome measures (4)
  • Pain Intensity (NRS) [Time frame: Pre- intervention, post- intervention (6 weeks) and follow-up of 8 weeks after the end]
  • Pressure Pain Threshold (PPT) [Time frame: Pre- intervention, post- interventio (6 weeks) and follow-up of 8 weeks after the end.]
  • Maximum Pain-Free Mouth Opening (MPMO) [Time frame: Pre- intervention, post- intervention (6 weeks) and follow-up of 8 weeks after the end.]
  • Treatment Adherence [Time frame: Post- intervention (6 weeks)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Universidad de Alcalá De Henares — Madrid

Identifiers

NCT: NCT07056725 · CEIM/2025/3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗