Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders

NCT ID: NCT05167656

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-12

Study Completion Date

2026-11-30

Brief Summary

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The aim of this randomized controlled trial is to evaluate the effects of intraoral manual therapy versus extraoral manual therapy and compare them with a control group, in the management of patients with temporomandibular disorders regarding pain, strength, quality of life, disability and anxiety.

Detailed Description

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Conditions

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Temporomandibular Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Researchers involved in recording outcome measures will not be aware of treatment allocation. Patients will be encouraged to not tell the evaluators about the received treatment.

Study Groups

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Intraoral Manual Therapy plus exercise and education.

Six sessions of intraoral manual therapy plus exercise and counselling.

Group Type EXPERIMENTAL

Intraoral manual therapy

Intervention Type OTHER

Six intraoral manual therapy sessions based on ischemic compression and pain pressure release of the temporomandibular region muscles, applied bilateral.

Exercise and counselling

Intervention Type OTHER

Information about etiology, contributing and related factors, natural history and prognostic of the pathology of temporomandibular disorders.

Counselling based on: diet, habits like tabacism, stress and anxiety control, physical activity and awareness of dental clenching.

Exercise daily program based on active and passive mobility of the temporomandibular joint, stretching exercises and self massage.

Extraoral Manual Therapy plus exercise and education.

Six sessions of extraoral manual therapy plus exercise and counselling.

Group Type EXPERIMENTAL

Extraoral manual therapy

Intervention Type OTHER

Six extraoral manual therapy sessions based on ischemic compression, pain pressure release and pressure sliding of the temporomandibular region muscles, applied bilateral.

Exercise and counselling

Intervention Type OTHER

Information about etiology, contributing and related factors, natural history and prognostic of the pathology of temporomandibular disorders.

Counselling based on: diet, habits like tabacism, stress and anxiety control, physical activity and awareness of dental clenching.

Exercise daily program based on active and passive mobility of the temporomandibular joint, stretching exercises and self massage.

Exercise and education.

Exercise and counselling alone without any manual therapy treatment.

Group Type ACTIVE_COMPARATOR

Exercise and counselling

Intervention Type OTHER

Information about etiology, contributing and related factors, natural history and prognostic of the pathology of temporomandibular disorders.

Counselling based on: diet, habits like tabacism, stress and anxiety control, physical activity and awareness of dental clenching.

Exercise daily program based on active and passive mobility of the temporomandibular joint, stretching exercises and self massage.

Interventions

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Intraoral manual therapy

Six intraoral manual therapy sessions based on ischemic compression and pain pressure release of the temporomandibular region muscles, applied bilateral.

Intervention Type OTHER

Extraoral manual therapy

Six extraoral manual therapy sessions based on ischemic compression, pain pressure release and pressure sliding of the temporomandibular region muscles, applied bilateral.

Intervention Type OTHER

Exercise and counselling

Information about etiology, contributing and related factors, natural history and prognostic of the pathology of temporomandibular disorders.

Counselling based on: diet, habits like tabacism, stress and anxiety control, physical activity and awareness of dental clenching.

Exercise daily program based on active and passive mobility of the temporomandibular joint, stretching exercises and self massage.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Unilateral temporomandibular pain for more than one month.
* Older than eighteen.
* No previous treatment to temporomandibular pain in the last 3 months.
* Diagnosed based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).

Exclusion Criteria

* Patients with cervical or cranial trauma or whiplash.
* Diagnosed with systemic disease, like rheumatoid arthritis or fibromyalgia.
* Diagnosed of any vascular or metabolic disease.
* Previous cervical or temporomandibular surgery.
* Dental, medicine or any physical therapy treatment in the last 3 months before the beginning of the interventions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Jorge Ballesteros Frutos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alcalá

Alcalá de Henares, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Jorge Ballesteros Frutos, PhD student

Role: CONTACT

638332255

Jorge Ballesteros Frutos

Role: CONTACT

+34 638 33 22 55

Facility Contacts

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Jorge Ballesteros, PhD Student

Role: primary

638332255

Other Identifiers

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CEID/2021/4/087

Identifier Type: -

Identifier Source: org_study_id

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