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

Study Overview
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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.

Official Title
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The Effectiveness of the Pressure Release Technique on Masticatory and Neck Muscle Trigger Points in Patients With Chronic Myofascial Temporomandibular Disorder

Conditions
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Myofascial Pain Syndrome, Temporomandibular Disorder

Intervention / Treatment
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* Other: Manual pressure release technique on trigger points.
* Other: Sham


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: clinical trial, prospective, randomized and experimental with masking of the statistician and the participants
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham simulation group<br>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<br>* A simulated pressure release technique is applied around masticatory and neck muscles.<br>* Other names: Placebo;|
| Experimental: Pressure release technique group<br>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.<br>* 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).<br>* Other names: Myofascial release;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Pain Pressure Thresholds Anterior Temporalis | 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. | Change from baseline in the scale at post-treatment and at 3 months later | 
| Changes in the Range of the Opening of the Mouth | A calibrator Dentaurum München was used, measured in millimetres, with 0 representing no opening/worst outcome and as higher values/as a better outcome. | Change from baseline in the scale at post-treatment and at 3 months later | 
| Changes in the Neck Disability | The Neck Disability Index was used (0-50), with 0 representing no disability neck/best outcome and 50 maximum disability neck/worst outcome. | Change from baseline in the scale at post-treatment and at 3 months later | 
| Changes in the Kinesiophobia | 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. | Change from baseline in the scale at post-treatment and at 3 months later | 
| Changes in the Catastrophizing | 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. | Change from baseline in the scale at post-treatment and at 3 months later | 
| Changes in the State Anxiety | 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. | Change from baseline in the scale at post-treatment and at 3 months later | 
| Changes in the State Depression | 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 | Change from baseline in the scale at post-treatment and at 3 months later | 
| Changes in the Trait Anxiety | 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. | Change from baseline in the scale at post-treatment and at 3 months later | 
| Changes in the Trait Depression | 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 | Change from baseline in the scale at post-treatment and at 3 months later | 
| Changes of Pain Pressure Thresholds Upper Trapezius | 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. | Change from baseline in the scale at post-treatment and at 3 months later | 
| Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid | 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. | Change from baseline in the scale at post-treatment and at 3 months later | 
| Changes of Pain Pressure Thresholds Superficial Masseter | 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. | Change from baseline in the scale at post-treatment and at 3 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Physical Therapy modalities