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

Temporomandibular Disorder Clinical Trial

— TrP-TMD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619889
• Other study ID #: Geseher
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: September 30, 2017

Study information

• Verified date: March 2020
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 30, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• 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).
• Sham
A simulated pressure release technique is applied around masticatory and neck muscles.

Locations

Country	Name	City	State
Spain	Odontology Faculty. Complutense University of Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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