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

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Control 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: Intervention 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




Primary Outcome Measures :
  1. Effectiveness of the treatment in perceived pain. Effect size [ Time Frame: Change from baseline in the scale at post-treatment and at 3 months later ]
    The Visual Analog Scale (1-10) was used, lower values represent a better outcome. the clinical minimum relevance outcome is at least a change of 1.2 points in the scale.


Secondary Outcome Measures :
  1. Effectiveness of the treatment in the pain pressure thresholds [ 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/cm2, higher values represent a better outcome.

  2. Effectiveness of the treatment 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 callibrator Dentaurum München was used, measured in millimetres, higher values represent a better outcome.

  3. Effectiveness of the treatment 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), lower values represent a better outcome.

  4. Effectiveness of the treatment 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), lower values represent a better outcome.

  5. Effectiveness of the treatment 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), lower values represent a better outcome.

  6. Effectiveness of the treatment in the 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

  7. Effectiveness of the treatment in the 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



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

Inclusion Criteria:

  • Patients >20 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619889


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

Responsible Party: Gema Serrano-Hernanz, Principal Investigator, Clinical Professor, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT03619889     History of Changes
Other Study ID Numbers: Geseher
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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