Temporomandibular Disorder Clinical Trial
— TrP-TMDOfficial title:
The Effectiveness of the Pressure Release Technique on Masticatory and Neck Muscle Trigger Points in Patients With Chronic Myofascial Temporomandibular Disorder
NCT number | NCT03619889 |
Other study ID # | Geseher |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | September 30, 2017 |
Verified date | March 2020 |
Source | Universidad Complutense de Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 74 |
Est. completion date | September 30, 2017 |
Est. primary completion date | April 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Odontology Faculty. Complutense University of Madrid | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Complutense de Madrid |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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