The Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder (TrP-TMD)

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

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Disorder; Myofascial Pain Syndrome
• Intervention / Treatment: Other: Sham; Other: Manual pressure release technique on trigger points.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Odontology Faculty. Complutense University of Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Sham simulation group; 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; A simulated pressure release technique is applied around masticatory and neck muscles.; Other Names: Placebo
EXPERIMENTAL: Pressure release technique group; 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.; 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).; Other Names: Myofascial release

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Principal Investigator: Gema Serrano-Hernanz, Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2015
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ACTUAL): September 30, 2017

Study Registration Dates

• First Submitted: May 27, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (ACTUAL): August 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Chronic Pain; Physical Therapy modalities
• Additional Relevant MeSH Terms: Nervous System Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: Geseher

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No