Effectiveness of a Manual Therapy Protocol in Patients With Masticatory Muscle Disorders

NCT ID: NCT03556150

Last Updated: 2018-09-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2018-09-03

Brief Summary

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Comparing the efficiency between manual therapy protocol and effleurage in patients with temporomandibular disorders.

Detailed Description

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The investigators want to get better insights into the outcome of a manual therapy protocol compare with effleurage. The treatment is meant for people who has masticatory muscle disorders. Besides, if the trial can reduce the pain's intensity and the trial can improve range of motion in the dysfunction of temporomandibular joint. The results will be register on the short and long term.

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

Study Groups

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Manual Therapy protocol

Massages, mobilisation and stretching techniques in the most painful joint

Group Type EXPERIMENTAL

Manual Therapy protocol

Intervention Type OTHER

This protocol consists of:

* Six minutes of joint's mobilisation (two minutes of each technique).
* Nine minutes of ischemic pressure . Three minutes per muscle in this order: temporal muscle, masseter muscle and lateral pterygoid. Choosing the two most painful trigger points.
* Three minutes of trigemino's nerve stretching.

Effleurage

Superficial massage in the most painful joint.

Group Type ACTIVE_COMPARATOR

Effleurage

Intervention Type OTHER

The protocol consists of:

* Five minutes in temporal muscle.
* Ten minutes superficial massage in the neck and cheek of the most painful joint.
* Five minutes of effleurage in the cheek, with the index finger inside the mouth and the thumb outside.

Interventions

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Manual Therapy protocol

This protocol consists of:

* Six minutes of joint's mobilisation (two minutes of each technique).
* Nine minutes of ischemic pressure . Three minutes per muscle in this order: temporal muscle, masseter muscle and lateral pterygoid. Choosing the two most painful trigger points.
* Three minutes of trigemino's nerve stretching.

Intervention Type OTHER

Effleurage

The protocol consists of:

* Five minutes in temporal muscle.
* Ten minutes superficial massage in the neck and cheek of the most painful joint.
* Five minutes of effleurage in the cheek, with the index finger inside the mouth and the thumb outside.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who are between 18 and 60 years old.
* Patients who have myofascial pain or myofascial pain and restricted oral opening taking into account Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
* Patients who have pain in their masticatory muscles while they are doing functional activities with their temporomandibular joint for, at least, the last six months.

Exclusion Criteria

* Patients who cannot receive manual therapy.
* Patients who took or have been taking pills in the last two months before they start in the trial like: antidepressants, antiepileptics, muscle relaxants or medications for metabolic diseases; because they affect the musculoskeletal system.
* Surgery intervention in the temporomandibular joint.
* Patients who have received physiotherapy sessions in the last six months.
* Red flags: malignant or inflammatory tumors, infectious diseases that contraindicate manual therapy, cervical surgery, previous history of whiplash, fibromyalgia, trigeminal neuralgia, osteoarthritis or rheumatoid arthritis.
* Patients who lost their teeth (excluding the third molar) or people using a total or partial dentures.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Beatriz Martín Bravo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beatriz M. Bravo, Physiotherapy

Role: PRINCIPAL_INVESTIGATOR

Investigator

Inmaculada T. Tejada, Physiotherapy

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

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University of Alcalá

Alcalá de Henares, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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CEIM/HU/2018/05

Identifier Type: -

Identifier Source: org_study_id

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