Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders

Sponsor

University of Nove de Julho (Other)

Overall Status

Recruiting

CT.gov ID

NCT05761106

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

TMD 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 TMD. 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 TMD) and Group B (Treatment Oculomotor plus Treatment for TMD). 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.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Disorder Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Convergence Insufficiency	Other: Oculomotor Therapy Other: Therapy for TMD	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 intervention.The other will be responsible for the treatment phase:Treatment for TMD and Treatment Oculomotor plus Treatment for TMD.A third-party collaborator will process and statistically analyze the collected data. Individuals will be randomized using the statistical program presented at www.randomization.com, 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.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 intervention.The other will be responsible for the treatment phase:Treatment for TMD and Treatment Oculomotor plus Treatment for TMD.A third-party collaborator will process and statistically analyze the collected data. Individuals will be randomized using the statistical program presented at www.randomization.com, 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.

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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 TMD 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, TMJ 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 TMD It will consist exercise of a ATM and cervical spine.

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 TMD

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, TMJ 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 TMD

It will consist exercise of a ATM and cervical spine.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 TMD, by DC/TMD;
Moderate and Severe TMD 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.