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Quality of Life and Sleep in Patients With Temporomandibular Disorders

ConditionTemporomandibular Disorders (TMDs)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Jaén

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Manual Therapy and Therapeutic Exercises Programs

    Other intervention

    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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Pre-intervention, post-intervention (6 weeks) and follow-up of 8 weeks after the end
2

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.

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

Secondary outcomes

1

Pain Intensity (NRS)

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.

Time frame
Pre- intervention, post- intervention (6 weeks) and follow-up of 8 weeks after the end
2

Pressure Pain Threshold (PPT)

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.

Time frame
Pre- intervention, post- interventio (6 weeks) and follow-up of 8 weeks after the end.
3

Maximum Pain-Free Mouth Opening (MPMO)

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.

Time frame
Pre- intervention, post- intervention (6 weeks) and follow-up of 8 weeks after the end.
4

Treatment Adherence

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.

Time frame
Post- intervention (6 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Jaén

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: