Skip to main content
OpenTrials
Completed

NCT Number: NCT03619889

The Effectiveness of a Physiotherapy Technique 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myofascial Pain Syndrome Chronic Pain Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Temporomandibular Disorder Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odontology Faculty. Complutense University of Madrid

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual pressure release technique on trigger points.

Other

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

SHAM

Other

A simulated pressure release technique is applied around masticatory and neck muscles.

Other names: Placebo

Primary outcomes

  1. Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique)

    Time frame: 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 outcomes

  1. Changes of Pain Pressure Thresholds Anterior Temporalis

    Time frame: 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.

  2. Changes in the Range of the Opening of the Mouth

    Time frame: 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.

  3. Changes in the Neck Disability

    Time frame: 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.

  4. Changes in the Kinesiophobia

    Time frame: 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.

  5. Changes in the Catastrophizing

    Time frame: 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.

  6. Changes in the State Anxiety

    Time frame: 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.

  7. Changes in the State Depression

    Time frame: 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

  8. Changes in the Trait Anxiety

    Time frame: 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.

  9. Changes in the Trait Depression

    Time frame: 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

  10. Changes of Pain Pressure Thresholds Upper Trapezius

    Time frame: 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.

  11. Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid

    Time frame: 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.

  12. Changes of Pain Pressure Thresholds Superficial Masseter

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Acronym: TrP-TMD

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 8, 2018
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.