Clinical trial NCT03619889: The Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder
Official title: The Effectiveness of the Pressure Release Technique on Masticatory and Neck Muscle Trigger Points in Patients With Chronic Myofascial Temporomandibular Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Temporomandibular Disorder
Keywords: Chronic Pain
Physical Therapy modalities
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: clinical trial, prospective, randomized and experimental with masking of the statistician and the participants
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique)
timeFrame: Change from baseline in the scale at post-treatment and at 3 months later
Secondary outcomes:
measure: Changes of Pain Pressure Thresholds Anterior Temporalis
timeFrame: Change from baseline in the scale at post-treatment and at 3 months later
measure: Changes in the Range of the Opening of the Mouth
timeFrame: Change from baseline in the scale at post-treatment and at 3 months later
measure: Changes in the Neck Disability
timeFrame: Change from baseline in the scale at post-treatment and at 3 months later
measure: Changes in the Kinesiophobia
timeFrame: Change from baseline in the scale at post-treatment and at 3 months later
measure: Changes in the Catastrophizing
timeFrame: Change from baseline in the scale at post-treatment and at 3 months later
measure: Changes in the State Anxiety
timeFrame: Change from baseline in the scale at post-treatment and at 3 months later
measure: Changes in the State Depression
timeFrame: Change from baseline in the scale at post-treatment and at 3 months later
measure: Changes in the Trait Anxiety
timeFrame: Change from baseline in the scale at post-treatment and at 3 months later
measure: Changes in the Trait Depression
timeFrame: Change from baseline in the scale at post-treatment and at 3 months later
measure: Changes of Pain Pressure Thresholds Upper Trapezius
timeFrame: Change from baseline in the scale at post-treatment and at 3 months later
measure: Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid
timeFrame: Change from baseline in the scale at post-treatment and at 3 months later
measure: Changes of Pain Pressure Thresholds Superficial Masseter
timeFrame: Change from baseline in the scale at post-treatment and at 3 months later
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Odontology Faculty. Complutense University of Madrid
Study officials:
affiliation: Universidad Complutense de Madrid
name: Gema Serrano-Hernanz
role: PRINCIPAL_INVESTIGATOR
References: