Quality of Life and Sleep in Patients With Temporomandibular Disorders

NCT07056725 | Not Yet Recruiting

• 1 other identifier: CEIM/2025/3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Temporomandibular Disorders (TMDs)

Keywords

Manual Therapy; Therapeutic Exercise; Quality of life; Quality of Sleep

Outcome Measures

Primary Outcomes (2)

• Quality of Life (SF-12)

  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.

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

• Sleep Quality (Pittsburgh Sleep Quality Index)

  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.

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

Secondary Outcomes (4)

• Pain Intensity (NRS)

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

• Pressure Pain Threshold (PPT)

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

• Maximum Pain-Free Mouth Opening (MPMO)

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

• Treatment Adherence

  Post- intervention (6 weeks)

Study Arms (2)

Group 1

EXPERIMENTAL

Subjects in this group will receive physiotherapy treatment consisting of a Manual Therapy program targeting the orofacial region, combined with a Cervical Therapeutic Exercise program. The Cervical Therapeutic Exercise program focuses on co-contraction exercises of the flexor and extensor muscles, progressively increasing difficulty and resistance through the use of a latex band (Theraband), along with neural tissue techniques.

Other: Manual Therapy and Therapeutic Exercises Programs

Group 2

EXPERIMENTAL

Subjects in this group will receive physiotherapy treatment consisting of a Manual Therapy program targeting the orofacial region, combined with an Orofacial Therapeutic Exercise program. The Orofacial Therapeutic Exercise program focuses on coordination exercises of the masseter muscles, progressively increasing difficulty and resistance, and is combined with neural tissue techniques.

Other: Manual Therapy and Therapeutic Exercises Programs

Interventions

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

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Universidad de Alcalá De Henares

Madrid, Alcalá de Henares, 28801, Spain

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Jaime Martínez Barros

CONTACT

+ 34 686052159; fisiojmb@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: An experimental study is proposed in the form of a Randomized Controlled Trial (RCT), longitudinal and prospective in design, with two intervention groups. Patients with Temporomandibular Disorders (TMD) will be randomly assigned to two intervention groups (G1 and G2), ensuring that participants in both groups present with similar baseline characteristics. The 25 requirements proposed by the CONSORT declaration will be followed

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 9, 2025
• Study Start: August 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)