Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders

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

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.

Study Overview

• Status: Recruiting
• Conditions: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Temporomandibular Disorder; Convergence Insufficiency
• Intervention / Treatment: Other: Oculomotor Therapy; Other: Therapy for Temporomandibular Disorder

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Mogi das Cruzes, SP, Brazil, 08771-910
      • Recruiting
      • Daniela Aparecida Biasotto Gonzalez
      • Contact: Daniela AB Biasotto-Gonzalez, Doctor; Phone Number: 11999063166; Email: biasottogonzalez@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Oculomotor Therapy; It will consist exercise of a convergence technique and an accommodative technique.
Active Comparator: 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).	Other: Oculomotor Therapy; It will consist exercise of a convergence technique and an accommodative technique.; Other: Therapy for Temporomandibular Disorder; It will consist exercise of a ATM and cervical spine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score in Numerical Pain Scale	intensity of pain	The level of pain at 12 weeks
Score in Numerical Pain Scale	intensity of pain	The level of pain at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure range of motion	range of motion	The range of motionat 12 weeks
measure range of motion	range of motion	The range of motion at 3 months

Collaborators and Investigators

• Sponsor: University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Physiotherapy; Clinical trials; Temporomandibular Disorder; Convergence Insufficiency; oculomotor therapy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Strabismus; Myofascial Pain Syndromes; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Ocular Motility Disorders
• Other Study ID Numbers: Convergence Insufficiency

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data is confi dential, but if any journal requests open data for publication for sure we will provide our database

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No