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

• ClinicalTrials.gov Identifier: NCT03619889
• Recruitment Status: Completed
• First Posted: August 8, 2018
• Results First Posted: October 24, 2019
• Last Update Posted: March 20, 2020
• Sponsor: Universidad Complutense de Madrid
• Information provided by (Responsible Party): Gema Serrano-Hernanz, Universidad Complutense de Madrid

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Myofascial Pain Syndrome; Temporomandibular Disorder	Other: Manual pressure release technique on trigger points.; Other: Sham	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: clinical trial, prospective, randomized and experimental with masking of the statistician and the participants
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Participants don´t know to which group are assigned The statistical assessor don´t know the aim of the study
• Primary Purpose: Treatment
• Official Title: The Effectiveness of the Pressure Release Technique on Masticatory and Neck Muscle Trigger Points in Patients With Chronic Myofascial Temporomandibular Disorder
• Actual Study Start Date: October 2015
• Actual Primary Completion Date: April 1, 2017
• Actual Study Completion Date: September 30, 2017

Arms and Interventions

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 Name: 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 Name: Myofascial release

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Spain

Odontology Faculty. Complutense University of Madrid

Madrid, Spain, 28040

Sponsors and Collaborators

Universidad Complutense de Madrid

Investigators

• Principal Investigator: Gema Serrano-Hernanz; Universidad Complutense de Madrid

  Study Documents (Full-Text)

Documents provided by Gema Serrano-Hernanz, Universidad Complutense de Madrid:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] March 16, 2015

More Information

• Responsible Party: Gema Serrano-Hernanz, Principal Investigator, Clinical Professor, Universidad Complutense de Madrid
• ClinicalTrials.gov Identifier: NCT03619889
• Other Study ID Numbers: Geseher
• First Posted: August 8, 2018
• Results First Posted: October 24, 2019
• Last Update Posted: March 20, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gema Serrano-Hernanz, Universidad Complutense de Madrid:

Chronic Pain; Physical Therapy modalities

Additional relevant MeSH terms:

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Myofascial Pain Syndromes; Fibromyalgia; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases