Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders

Temporomandibular Disorder Clinical Trial

Official title:

Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders: Clinical, Randomized, Blinded Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05761106
• Other study ID #: Convergence Insufficiency
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Convergence Insufficiency
• Joint Diseases
• Ocular Motility Disorders
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• Oculomotor Therapy
It will consist exercise of a convergence technique and an accommodative technique.
• Therapy for Temporomandibular Disorder
It will consist exercise of a ATM and cervical spine.

Locations

Country	Name	City	State
Brazil	Daniela Aparecida Biasotto Gonzalez	Mogi das Cruzes	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score in Numerical Pain Scale	intensity of pain	The level of pain at 12 weeks
Primary	Score in Numerical Pain Scale	intensity of pain	The level of pain at 3 months
Secondary	measure range of motion	range of motion	The range of motionat 12 weeks
Secondary	measure range of motion	range of motion	The range of motion at 3 months