The Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder

NCT ID: NCT03619889

Last Updated: 2020-03-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-09-30

Brief Summary

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Participants with chronic orofacial pain caused by masticatory and neck muscles will be distributed in two groups, both followed with the same occlusal and self-care treatment. The experimental group will receive 5 sessions of physiotherapy applying a specific pressure on the trigger points while the control group will receive placebo through a simulation of the same technique. Orofacial perceived pain, pain pressure thresholds, catastrophizing, kinesiophobia, cervical disability, depression and anxiety will be evaluated at baseline, immediately after treatment and 3 months later.

Detailed Description

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Conditions

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Myofascial Pain Syndrome Temporomandibular Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

clinical trial, prospective, randomized and experimental with masking of the statistician and the participants
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants don´t know to which group are assigned The statistical assessor don´t know the aim of the study

Study Groups

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Sham simulation group

A simulation of the pressure release technique, applying a soft pressure or contact in the same muscles sites or trigger points than in the intervention group.

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

A simulated pressure release technique is applied around masticatory and neck muscles.

Pressure release technique group

The release pressure technique is applied in the trigger points of masticatory and neck muscles (upper trapezius, sternal and clavicular sternocleidomastoid, deep and superficial masseter, posterior, medium and anterior temporalis.

Group Type EXPERIMENTAL

Manual pressure release technique on trigger points.

Intervention Type OTHER

A specific pressure is applied on trigger points of masticatory and neck muscles between pain pressure threshold and pain tolerance (7-8 visual analog scale).

Interventions

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Manual pressure release technique on trigger points.

A specific pressure is applied on trigger points of masticatory and neck muscles between pain pressure threshold and pain tolerance (7-8 visual analog scale).

Intervention Type OTHER

Sham

A simulated pressure release technique is applied around masticatory and neck muscles.

Intervention Type OTHER

Other Intervention Names

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Myofascial release Placebo

Eligibility Criteria

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Inclusion Criteria

* Patients ≥18 years.
* Patients diagnosed of myofascial TMD with at least one TrP with referred pain.
* TMD patients with a current complaint of myofascial pain with more than 6 months of evolution.
* Patients with myofascial TMD initially treated with splint currently used, that has not been modified in the last 6 months, without improvement.

Exclusion Criteria

* Patients treated with occlusal splint recently modified.
* Patients with acute TMJ diseases.
* Patients with systemic disease, neurological and muscular diseases.
* Patients with psychiatric or psychological disorders.
* Patients with cervical disc hernia and acute whiplash injury.
* Changes in the painkillers intake during the experiment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Gema Serrano-Hernanz

Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gema Serrano-Hernanz

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Locations

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Odontology Faculty. Complutense University of Madrid

Madrid, , Spain

Site Status

Countries

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Spain

References

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Serrano-Hernanz G, Angulo-Carrere T, Ardizone-Garcia I, Svensson P, Alvarez-Mendez AM. Pressure release technique versus placebo applied to cervical and masticatory muscles in patients with chronic painful myofascial temporomandibular disorder: A randomised clinical trial. J Oral Rehabil. 2023 Sep;50(9):782-791. doi: 10.1111/joor.13490. Epub 2023 May 25.

Reference Type DERIVED
PMID: 37163204 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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Geseher

Identifier Type: -

Identifier Source: org_study_id

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