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

NCT03619889 | Completed Results

• 1 other identifier: Geseher
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myofascial Pain Syndrome; Temporomandibular Disorder

Keywords

Chronic Pain; Physical Therapy modalities

Outcome Measures

Primary Outcomes (1)

• Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique)

  The Visual Analogue Scale (0-10) was used, 0 representing no pain/better outcome, and 10 representing unbearable pain/worst outcome. the clinical minimum relevance outcome is at least a change of 1.2 points in the scale.

  Change from baseline in the scale at post-treatment and at 3 months later

Secondary Outcomes (12)

• Changes of Pain Pressure Thresholds Anterior Temporalis

  Change from baseline in the scale at post-treatment and at 3 months later

• Changes in the Range of the Opening of the Mouth

  Change from baseline in the scale at post-treatment and at 3 months later

• Changes in the Neck Disability

  Change from baseline in the scale at post-treatment and at 3 months later

• Changes in the Kinesiophobia

  Change from baseline in the scale at post-treatment and at 3 months later

• Changes in the Catastrophizing

  Change from baseline in the scale at post-treatment and at 3 months later

Study Arms (2)

Sham simulation group

SHAM COMPARATOR

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.

Other: Sham

Pressure release technique group

EXPERIMENTAL

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.

Other: Manual pressure release technique on trigger points.

Interventions

Manual pressure release technique on trigger points. 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).

Also known as: Myofascial release

Pressure release technique group

Sham OTHER

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

Also known as: Placebo

Sham simulation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Odontology Faculty. Complutense University of Madrid

Madrid, 28040, Spain

Location

Related Publications (1)

• 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.

  PMID: 37163204 DERIVED

MeSH Terms

Conditions

Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Chronic Pain

Interventions

Myofascial Release Therapy; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Joint Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Dra. Gema Serrano-Hernanz
• Organization: Universidad Complutense de Madrid

gema.serrano.hernanz@gmail.com, gemase01@ucm.es

669332986

Study Officials

• Gema Serrano-Hernanz

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants don´t know to which group are assigned The statistical assessor don´t know the aim of the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: clinical trial, prospective, randomized and experimental with masking of the statistician and the participants

Study Record Dates

• First Submitted: May 27, 2018
• First Posted: August 8, 2018
• Study Start: October 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: September 30, 2017
• Last Updated: March 20, 2020
• Results First Posted: October 24, 2019

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)