Clinical trial NCT05761106: Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders
Official title: Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders: Clinical, Randomized, Blinded Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Disorder
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Convergence Insufficiency
Keywords: Convergence Insufficiency
Temporomandibular Disorder
Clinical trials
oculomotor therapy
Physiotherapy
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two researchers will be part of the protocol.One will be responsible for pre and post intervention assessments and will be blind to the type of interventionThe other will be responsible for the treatment phase:Treatment for Temporomandibular Disorder (TMD) and Treatment Oculomotor plus Treatment for TMD. A third-party collaborator will process and statistically analyze the collected data.Individuals will be randomize using the statistical program, two groups.Randomization and concealment of allocation will be made by a fourth external employee,not a research participant, who will organize the allocation in individual opaque envelopes and keep it confidential.There will be 2 blocks of 25 envelopes:Treatment for TMD and Treatment Oculomotor plus Treatment for TMD.With this process, participants will have the same probability of being allocated to one of the two treatment groups.Blinding of the evaluator will be maintained until the end of the research and data tabulation.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Score in Numerical Pain Scale
timeFrame: The level of pain at 12 weeks
measure: Score in Numerical Pain Scale
timeFrame: The level of pain at 3 months
Secondary outcomes:
measure: measure range of motion
timeFrame: The range of motionat 12 weeks
measure: measure range of motion
timeFrame: The range of motion at 3 months
Other outcomes:
Locations:
city: Mogi das Cruzes
country: Brazil
facility: Daniela Aparecida Biasotto Gonzalez
state: SP
Study officials:
References: