Back to resultsThe Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder (TrP-TMD)
Primary Purpose
Myofascial Pain Syndrome, Temporomandibular Disorder
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual pressure release technique on trigger points.
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Chronic Pain, Physical Therapy modalities
Eligibility 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.
Sites / Locations
- Odontology Faculty. Complutense University of Madrid
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Sham simulation group
Pressure release technique group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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
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.
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
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.
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.
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.
Full Information
NCT ID
NCT03619889
First Posted
May 27, 2018
Last Updated
March 19, 2020
Sponsor
Universidad Complutense de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT03619889
Brief Title
The Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome, Temporomandibular Disorder
Keywords
Chronic Pain, Physical Therapy modalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
clinical trial, prospective, randomized and experimental with masking of the statistician and the participants
Masking
ParticipantOutcomes Assessor
Masking Description
Participants don´t know to which group are assigned The statistical assessor don´t know the aim of the study
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham simulation group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Pressure release technique group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manual pressure release technique on trigger points.
Other Intervention Name(s)
Myofascial release
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Sham
Other Intervention Name(s)
Placebo
Intervention Description
A simulated pressure release technique is applied around masticatory and neck muscles.
Primary Outcome Measure Information:
Title
Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique)
Description
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.
Time Frame
Change from baseline in the scale at post-treatment and at 3 months later
Secondary Outcome Measure Information:
Title
Changes of Pain Pressure Thresholds Anterior Temporalis
Description
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.
Time Frame
Change from baseline in the scale at post-treatment and at 3 months later
Title
Changes in the Range of the Opening of the Mouth
Description
A calibrator Dentaurum München was used, measured in millimetres, with 0 representing no opening/worst outcome and as higher values/as a better outcome.
Time Frame
Change from baseline in the scale at post-treatment and at 3 months later
Title
Changes in the Neck Disability
Description
The Neck Disability Index was used (0-50), with 0 representing no disability neck/best outcome and 50 maximum disability neck/worst outcome.
Time Frame
Change from baseline in the scale at post-treatment and at 3 months later
Title
Changes in the Kinesiophobia
Description
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.
Time Frame
Change from baseline in the scale at post-treatment and at 3 months later
Title
Changes in the Catastrophizing
Description
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.
Time Frame
Change from baseline in the scale at post-treatment and at 3 months later
Title
Changes in the State Anxiety
Description
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.
Time Frame
Change from baseline in the scale at post-treatment and at 3 months later
Title
Changes in the State Depression
Description
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
Time Frame
Change from baseline in the scale at post-treatment and at 3 months later
Title
Changes in the Trait Anxiety
Description
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.
Time Frame
Change from baseline in the scale at post-treatment and at 3 months later
Title
Changes in the Trait Depression
Description
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
Time Frame
Change from baseline in the scale at post-treatment and at 3 months later
Title
Changes of Pain Pressure Thresholds Upper Trapezius
Description
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.
Time Frame
Change from baseline in the scale at post-treatment and at 3 months later
Title
Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid
Description
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.
Time Frame
Change from baseline in the scale at post-treatment and at 3 months later
Title
Changes of Pain Pressure Thresholds Superficial Masseter
Description
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.
Time Frame
Change from baseline in the scale at post-treatment and at 3 months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gema Serrano-Hernanz
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odontology Faculty. Complutense University of Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder
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