Effect of Exercises on Convergence Insufficiency in Indiv... | NCT05761106

Studies
Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders

NCT05761106

Sponsor

University of Nove de Julho

Status

Unknown status

Last Update Posted

Mar 6, 2024Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Temporomandibular Disorder
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Convergence Insufficiency

Interventions

Oculomotor Therapy
Therapy for Temporomandibular Disorder

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Feb 27, 2023

First Submission Date that Met QC Criteria

Feb 27, 2023

First Posted Date

Mar 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2024

Last Update Posted Date

Mar 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oculomotor Therapy	Experimental	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
Therapy for Temporomandibular Disorder	Active Comparator	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 Other: Therapy for Temporomandibular Disorder

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oculomotor Therapy	Other	It will consist exercise of a convergence technique and an accommodative technique.	Oculomotor Therapy Therapy for Temporomandibular Disorder

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Daniela Aparecida Biasotto Gonzalez	Recruiting	Mogi das Cruzes	São Paulo	08771-910	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

The data is confi dential, but if any journal requests open data for publication for sure we will provide our database

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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.

ID	Term
D013705	Temporomandibular Joint Disorders
D013706	Temporomandibular Joint Dysfunction Syndrome
D015835	Ocular Motility Disorders

ID	Term
D017271	Craniomandibular Disorders
D008336	Mandibular Diseases
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases
D007592	Joint Diseases
D009135	Muscular Diseases
D009057	Stomatognathic Diseases
D009209	Myofascial Pain Syndromes
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D003389	Cranial Nerve Diseases
D005128	Eye Diseases