Quality of Life and Sleep in Patients With Temporomandibular Disorders
NCT ID: NCT07056725
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-08-31
2026-01-31
Brief Summary
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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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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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
TREATMENT
NONE
Study Groups
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Group 1
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.
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
Group 2
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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University of Jaén
OTHER
Responsible Party
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Alexander Achalandabaso
Clinical Professor
Locations
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Universidad de Alcalá De Henares
Madrid, Alcalá de Henares, Spain
Countries
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Central Contacts
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Other Identifiers
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CEIM/2025/3
Identifier Type: -
Identifier Source: org_study_id
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