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

Not Applicable

Completed

Conditions: Myofascial Pain Syndrome
Temporomandibular Disorder

Interventions: Other: Sham
Other: Manual pressure release technique on trigger points.

Registration Number: NCT03619889

Lead Sponsor: Universidad Complutense de Madrid

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 74

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham simulation group	Sham	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.
Pressure release technique group	Manual pressure release technique on trigger points.	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.

Primary Outcome Measures

Name	Time	Method
Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique)	Change from baseline in the scale at post-treatment and at 3 months later	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.

Secondary Outcome Measures

Name	Time	Method
Changes in the Neck Disability	Change from baseline in the scale at post-treatment and at 3 months later	The Neck Disability Index was used (0-50), with 0 representing no disability neck/best outcome and 50 maximum disability neck/worst outcome.
Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid	Change from baseline in the scale at post-treatment and at 3 months later	An algometer Wagner Force One FDX 50 was used, measured in kgf/cm\^2, with 0 representing the lowest pain pressure threshold/worst outcome and as higher pain pressure threshold/ as a better outcome.
Changes in the Kinesiophobia	Change from baseline in the scale at post-treatment and at 3 months later	The Tampa Scale for Kinesiophobia -11 was used (0-44), with 0 representing no kinesiophobia/best outcome and 44 representing the highest level of kinesiphobia/worst outcome.
Changes in the Trait Anxiety	Change from baseline in the scale at post-treatment and at 3 months later	The State-Trait Anxiety Index was used, lower values represent a better outcome. State and Trait were evaluated individually, range of scores for each subtest is 20-80, with 20 representing no trait anxiety/best outcome and 80 representing the highest level of trait anxiety/worst outcome.
Changes in the Range of the Opening of the Mouth	Change from baseline in the scale at post-treatment and at 3 months later	A calibrator Dentaurum München was used, measured in millimetres, with 0 representing no opening/worst outcome and as higher values/as a better outcome.
Changes in the Catastrophizing	Change from baseline in the scale at post-treatment and at 3 months later	The Pain Catastrophizing Scale was used (0-52), with 0 representing no catastrophizing/best outcome and 52 representing the highest level of catastrophizing/worst outcome.
Changes in the State Anxiety	Change from baseline in the scale at post-treatment and at 3 months later	The State-Trait Anxiety Index was used, lower values represent a better outcome. State and Trait were evaluated individually, range of scores for each subtest is 20-80, with 20 representing no state anxiety/best outcome and 80 representing the highest level of state anxiety/worst outcome.
Changes of Pain Pressure Thresholds Superficial Masseter	Change from baseline in the scale at post-treatment and at 3 months later	An algometer Wagner Force One FDX 50 was used, measured in kgf/cm\^2, with 0 representing the lowest pain pressure threshold/worst outcome and as higher pain pressure threshold/ as a better outcome.
Changes of Pain Pressure Thresholds Anterior Temporalis	Change from baseline in the scale at post-treatment and at 3 months later	An algometer Wagner Force One FDX 50 was used, measured in kgf/cm\^2, with 0 representing the lowest pain pressure threshold/worst outcome and as higher pain pressure threshold/ as a better outcome.
Changes in the State Depression	Change from baseline in the scale at post-treatment and at 3 months later	The State-Trait Depression Inventory was used, lower values represent a better outcome. State and Trait were evaluated individually, range of scores for each subtest is 20-80, with 20 representing no state depression/best outcome and 80 representing the highest level of state depression/worst outcome
Changes in the Trait Depression	Change from baseline in the scale at post-treatment and at 3 months later	The State-Trait Depression Inventory was used, lower values represent a better outcome. State and Trait were evaluated individually, range of scores for each subtest is 20-80, with 20 representing no Trait Depression/best outcome and 80 representing the highest level of Trait Depression/worst outcome
Changes of Pain Pressure Thresholds Upper Trapezius	Change from baseline in the scale at post-treatment and at 3 months later	An algometer Wagner Force One FDX 50 was used, measured in kgf/cm\^2, with 0 representing the lowest pain pressure threshold/worst outcome and as higher pain pressure threshold/ as a better outcome.