Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders

NCT ID: NCT05761106

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-12-31

Brief Summary

Temporomandibular Disorder is a disorder that involves the muscles of mastication, the temporomandibular joint (TMJ), and associated structures. Convergence insufficiency (CI) is characterized by the inability of the eyes to perform the eye adduction movement together, to focus on a nearby object. Studies show that there is a relationship between the presence of TMD and its signs and symptoms in patients with convergence insufficiency. Given this, the research question of this clinical trial is whether the effect of oculomotor therapy would be effective in improving the signs and symptoms of Temporomandibular Disorder. The design of this research is a Clinical Trial, Randomized and Blind. It will be divided into two moments: evaluation and intervention. The evaluations will be carried out using the Diagnostic Criteria for Temporomandibular Disorders: Fonseca Anamnestic Index (IAF), Clinical Protocol and Assessment Instruments (DC/TMD), Mandibular function Impairment Questionnaire (MFIQ), Numerical Pain Scale (END), Convergence Test, Meersseman Test and Convergence insufficiency symptom Survey (CISS). Individuals will be randomized into 2 groups: Group A (Treatment for Temporomandibular Disorder) and Group B (Treatment Oculomotor plus Treatment for Temporomandibular Disorder). Both groups will receive physiotherapeutic treatment for 12 weeks. Patients will be reassessed shortly after treatment, 3 and 6 months later. For data analysis, the statistical significance considered will be p<0.05.

Conditions

Temporomandibular Disorder; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Convergence Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oculomotor Therapy

The procedures for oculomotor therapy will be arranged sequentially, from easiest to most difficult. It will consist of a convergence technique (Brock Cord and Barrille Cartouche) and an accommodative technique (Eccentric circles or lifesaving cards) and Eye Relaxation.

Group Type: EXPERIMENTAL

Oculomotor Therapy

Intervention Type: OTHER

It will consist exercise of a convergence technique and an accommodative technique.

Therapy for Temporomandibular Disorder

Extra-oral and intra-oral massage: The main objective is to reduce pain as well as re-establish proper muscle length and flexibility. The patient will be instructed to use diaphragmatic breathing to promote relaxation during these massage procedures.

Myofascial release of the masseter, temporalis and sternocleidomastoid muscles, release of neck soft tissues, cervical pomp, suboccipital inhibition, passive anteroposterior mobilization of the upper cervical, cervical exercises, Temporomandibular Joint exercises (mouth opening exercise with tongue on palate) , Proprioceptive exercises).

Group Type: ACTIVE_COMPARATOR

Oculomotor Therapy

Intervention Type: OTHER

It will consist exercise of a convergence technique and an accommodative technique.

Therapy for Temporomandibular Disorder

Intervention Type: OTHER

It will consist exercise of a ATM and cervical spine.

Interventions

Oculomotor Therapy

It will consist exercise of a convergence technique and an accommodative technique.

Intervention Type: OTHER

Therapy for Temporomandibular Disorder

It will consist exercise of a ATM and cervical spine.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 60 years;
• Presence of pain in the facial region in the last 6 months;
• Presence of pain, at least 3 on the numeric pain scale (END), in the Temporomandibular Joint and/or masticatory muscles and in the last 6 months;
• Diagnosis of myogenic Temporomandibular Disorder, by DC/TMD;
• Moderate and Severe Temporomandibular Disorder carrier, according to Fonseca's Anamnestic Index;
• Presence of Insufficiency of Convergence according to Convergence Test (TC) and by Convergence insufficiency symptom Survey (CISS).

Exclusion Criteria

• Permanent strabismus;
• History of strabismus surgery;
• History of cervical and/or craniofacial trauma/surgical procedure;
• History of ocular nerve injury;
• Neurological disorders;
• disc disease ;
• Systemic diseases;
• Fibromyalgia diagnosis;
• Previous treatments for TMD carried out in the last 3 months;
• Previous treatments of Convergence Insufficiency with oculomotor therapy (no more than 2 months of treatment in the last year);
• Occlusal treatment in progress;
• Any ocular or systemic medication known to affect accommodation or vergence ;
• Systemic diseases that affect ocular accommodation, vergence , and motility, such as multiple sclerosis, Graves' thyroid disease, myasthenia gravis, diabetes, and Parkinson's disease;
• In continuous use of analgesics, anti-inflammatories, anxiolytics and/or antidepressants;
• Pregnant women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Daniela Ap. Biasotto-Gonzalez

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Daniela Aparecida Biasotto Gonzalez

Mogi das Cruzes, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Daniela AB Biasotto-Gonzalez, Doctor

Role: primary

biasottogonzalez@gmail.com

11999063166

Other Identifiers

Convergence Insufficiency

Identifier Type: -

Identifier Source: org_study_id