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NCT Number: NCT07056725

Quality of Life and Sleep in Patients With Temporomandibular Disorders

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.

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Key information

Conditions

Temporomandibular Disorders (TMDs) Craniomandibular Disorders Dyssomnias Jaw Diseases Joint Diseases Mandibular Diseases Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Alcalá De Henares

Madrid, Alcalá de Henares, 28801, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual Therapy and Therapeutic Exercises Programs

Other

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 outcomes

  1. Quality of Life (SF-12)

    Time frame: 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.

  2. Sleep Quality (Pittsburgh Sleep Quality Index)

    Time frame: 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.

Secondary outcomes

  1. Pain Intensity (NRS)

    Time frame: Pre- intervention, post- intervention (6 weeks) and follow-up of 8 weeks after the end

    The Numerical Rating Scale (NRS) is a widely used instrument for the subjective assessment of pain intensity.

    It consists of a numerical scale from 0 to 10, where 0 indicates no pain and 10 represents the highest intensity. Patients select the number that best reflects the severity of their symptom.

  2. Pressure Pain Threshold (PPT)

    Time frame: Pre- intervention, post- interventio (6 weeks) and follow-up of 8 weeks after the end.

    The tip of the algometer will be applied perpendicularly to the muscle (anterior portion of the temporalis muscle and the superficial belly of the masseter muscle), and pressure will be gradually increased at a rate of 1 kg/sec. Participants will be instructed to signal the moment they first perceive pain, in order to accurately record the pressure pain threshold.

  3. Maximum Pain-Free Mouth Opening (MPMO)

    Time frame: Pre- intervention, post- intervention (6 weeks) and follow-up of 8 weeks after the end.

    MPMO is a clinical measure used to assess mandibular function in patients with temporomandibular disorders (TMD). This variable evaluates the ability to open the mouth without experiencing pain, reflecting the functional status of the temporomandibular joint and the associated musculoskeletal structures.

  4. Treatment Adherence

    Time frame: Post- intervention (6 weeks)

    A personalized diary will be provided for each participant in both groups. Each program will include an exercise log that patients will be required to complete.

Study contacts

Contact information is provided by the study sponsor or research team.

Jaime Martínez Barros

CONTACT

[email protected]

+ 34 686052159

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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