Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders

NCT05761106 — Not applicable, Unknown, 24 participants, University of Nove de Julho

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

Registry	NCT05761106
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	24 (Estimated)
Sponsor	University of Nove de Julho (Other)
Conditions	Temporomandibular Disorder, Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Convergence Insufficiency
Interventions	Oculomotor Therapy, Therapy for Temporomandibular Disorder (Other)
Dates	start 2023-02-01, primary completion 2025-12-01 (estimated), completion 2025-12-01 (estimated), first posted 2023-03-09, last updated 2024-03-06
Locations	1 site in Brazil

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Oculomotor Therapy	Experimental	Other: 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.
Therapy for Temporomandibular Disorder	Active comparator	Other: Oculomotor Therapy; Other: 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).

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

+Outcome measures

Primary outcomes

Score in Numerical Pain Scale [The level of pain at 12 weeks]: intensity of pain
Score in Numerical Pain Scale [The level of pain at 3 months]: intensity of pain

Secondary outcomes

measure range of motion [The range of motionat 12 weeks]: range of motion
measure range of motion [The range of motion at 3 months]: range of motion

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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.

+Locations (1)

Facility	City	Country	Status
Daniela Aparecida Biasotto Gonzalez	Mogi das Cruzes, São Paulo	Brazil	Recruiting