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Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders

Primary Purpose

Temporomandibular Disorder, Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Oculomotor Therapy
Therapy for Temporomandibular Disorder
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder focused on measuring Convergence Insufficiency, Temporomandibular Disorder, Clinical trials, oculomotor therapy, Physiotherapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • Daniela Aparecida Biasotto GonzalezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oculomotor Therapy

Therapy for Temporomandibular Disorder

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Score in Numerical Pain Scale
intensity of pain
Score in Numerical Pain Scale
intensity of pain

Secondary Outcome Measures

measure range of motion
range of motion
measure range of motion
range of motion

Full Information

First Posted
February 27, 2023
Last Updated
March 14, 2023
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT05761106
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder, Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Convergence Insufficiency
Keywords
Convergence Insufficiency, Temporomandibular Disorder, Clinical trials, oculomotor therapy, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oculomotor Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Therapy for Temporomandibular Disorder
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Oculomotor Therapy
Intervention Description
It will consist exercise of a convergence technique and an accommodative technique.
Intervention Type
Other
Intervention Name(s)
Therapy for Temporomandibular Disorder
Intervention Description
It will consist exercise of a ATM and cervical spine.
Primary Outcome Measure Information:
Title
Score in Numerical Pain Scale
Description
intensity of pain
Time Frame
The level of pain at 12 weeks
Title
Score in Numerical Pain Scale
Description
intensity of pain
Time Frame
The level of pain at 3 months
Secondary Outcome Measure Information:
Title
measure range of motion
Description
range of motion
Time Frame
The range of motionat 12 weeks
Title
measure range of motion
Description
range of motion
Time Frame
The range of motion at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Daniela Aparecida Biasotto Gonzalez
City
Mogi das Cruzes
State/Province
SP
ZIP/Postal Code
08771-910
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela AB Biasotto-Gonzalez, Doctor
Phone
11999063166
Email
biasottogonzalez@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data is confi dential, but if any journal requests open data for publication for sure we will provide our database

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Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders

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