Myofascial Pain Syndrome, Temporomandibular Disorder
Conditions
Keywords
Chronic Pain, Physical Therapy modalities
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.
Interventions
OTHERManual 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).
OTHERSham
A simulated pressure release technique is applied around masticatory and neck muscles.
Sponsors
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants don´t know to which group are assigned The statistical assessor don´t know the aim of the study
Intervention model description
clinical trial, prospective, randomized and experimental with masking of the statistician and the participants
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique) | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Range of the Opening of the Mouth | 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. |
| Changes in the Neck Disability | 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. |
| Changes in the Kinesiophobia | 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. |
| Changes in the Catastrophizing | 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. |
| Changes in the State Anxiety | 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. |
| Changes of Pain Pressure Thresholds Anterior Temporalis | 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. |
| Changes in the Trait Anxiety | 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. |
| Changes in the Trait Depression | 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 |
| Changes of Pain Pressure Thresholds Upper Trapezius | 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. |
| Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid | 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. |
| Changes of Pain Pressure Thresholds Superficial Masseter | 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. |
| Changes in the State Depression | 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 |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Sham: A simulated pressure release technique is applied around masticatory and neck muscles. | 35 |
| 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.
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). | 37 |
| Total | 72 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 6 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 31 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 37 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Spain | 35 Participants | 37 Participants | 72 Participants |
| Sex: Female, Male Female | 31 Participants | 29 Participants | 60 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Simulation GROUP | Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique) | value at post-treatment minus value at baseline | -1.03 units on a scale | Standard Deviation 0.82 |
| Sham Simulation GROUP | Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique) | value at 3 months later minus value at baseline | -0.77 units on a scale | Standard Deviation 0.88 |
| Sham Simulation GROUP | Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique) | value at 3 months later minus value at post-treatm | 0.26 units on a scale | Standard Deviation 0.12 |
| Pressure Release Technique GROUP | Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique) | value at post-treatment minus value at baseline | -2.30 units on a scale | Standard Deviation 1.16 |
| Pressure Release Technique GROUP | Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique) | value at 3 months later minus value at baseline | -2.84 units on a scale | Standard Deviation 1.94 |
| Pressure Release Technique GROUP | Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique) | value at 3 months later minus value at post-treatm | -0.54 units on a scale | Standard Deviation 0.31 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
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.
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Simulation GROUP | Changes in the Catastrophizing | value at post-treatment minus value at baseline | 2.14 units on a scale | Standard Deviation 3.4 |
| Sham Simulation GROUP | Changes in the Catastrophizing | value at 3 months later minus value at baseline | 0.80 units on a scale | Standard Deviation 3.53 |
| Sham Simulation GROUP | Changes in the Catastrophizing | value at 3 months later minus value at post-treatm | -1.34 units on a scale | Standard Deviation 3.2 |
| Pressure Release Technique GROUP | Changes in the Catastrophizing | value at 3 months later minus value at baseline | 9.84 units on a scale | Standard Deviation 7.5 |
| Pressure Release Technique GROUP | Changes in the Catastrophizing | value at post-treatment minus value at baseline | 9.92 units on a scale | Standard Deviation 7.68 |
| Pressure Release Technique GROUP | Changes in the Catastrophizing | value at 3 months later minus value at post-treatm | -0.08 units on a scale | Standard Deviation 4.67 |
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.
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Simulation GROUP | Changes in the Kinesiophobia | value at post-treatment minus value at baseline | 1.80 units on a scale | Standard Deviation 2.65 |
| Sham Simulation GROUP | Changes in the Kinesiophobia | value at 3 months later minus value at baseline | 1.83 units on a scale | Standard Deviation 3.3 |
| Sham Simulation GROUP | Changes in the Kinesiophobia | value at 3 months later minus value at post-treatm | 0.03 units on a scale | Standard Deviation 2.63 |
| Pressure Release Technique GROUP | Changes in the Kinesiophobia | value at post-treatment minus value at baseline | 5.24 units on a scale | Standard Deviation 4.49 |
| Pressure Release Technique GROUP | Changes in the Kinesiophobia | value at 3 months later minus value at post-treatm | 0.68 units on a scale | Standard Deviation 2.43 |
| Pressure Release Technique GROUP | Changes in the Kinesiophobia | value at 3 months later minus value at baseline | 5.92 units on a scale | Standard Deviation 4.94 |
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.
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Simulation GROUP | Changes in the Neck Disability | value at 3 months later minus value at baseline | 0.40 units on a scale | Standard Deviation 1.61 |
| Sham Simulation GROUP | Changes in the Neck Disability | value at post-treatment minus value at baseline | 1.09 units on a scale | Standard Deviation 2.67 |
| Sham Simulation GROUP | Changes in the Neck Disability | value at 3 months later minus value at post-treatm | -0.69 units on a scale | Standard Deviation 2.48 |
| Pressure Release Technique GROUP | Changes in the Neck Disability | value at post-treatment minus value at baseline | 5.78 units on a scale | Standard Deviation 5.45 |
| Pressure Release Technique GROUP | Changes in the Neck Disability | value at 3 months later minus value at post-treatm | -0.38 units on a scale | Standard Deviation 4.08 |
| Pressure Release Technique GROUP | Changes in the Neck Disability | value at 3 months later minus value at baseline | 5.40 units on a scale | Standard Deviation 5.31 |
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.
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Simulation GROUP | Changes in the Range of the Opening of the Mouth | value at post-treatment minus value at baseline | -0.26 mm | Standard Deviation 5.81 |
| Sham Simulation GROUP | Changes in the Range of the Opening of the Mouth | value at 3 months later minus value at baseline | -1.09 mm | Standard Deviation 6.59 |
| Sham Simulation GROUP | Changes in the Range of the Opening of the Mouth | value at 3 months later minus value at post-treatm | -0.83 mm | Standard Deviation 1.81 |
| Pressure Release Technique GROUP | Changes in the Range of the Opening of the Mouth | value at post-treatment minus value at baseline | -4.27 mm | Standard Deviation 6.39 |
| Pressure Release Technique GROUP | Changes in the Range of the Opening of the Mouth | value at 3 months later minus value at baseline | -5.22 mm | Standard Deviation 6.68 |
| Pressure Release Technique GROUP | Changes in the Range of the Opening of the Mouth | value at 3 months later minus value at post-treatm | -0.95 mm | Standard Deviation 2.7 |
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.
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Simulation GROUP | Changes in the State Anxiety | value at post-treatment minus value at baseline | 0.30 units on a scale | Standard Deviation 0.93 |
| Sham Simulation GROUP | Changes in the State Anxiety | value at 3 months later minus value at baseline | 0.22 units on a scale | Standard Deviation 0.82 |
| Sham Simulation GROUP | Changes in the State Anxiety | value at 3 months later minus value at post-treatm | -0.08 units on a scale | Standard Deviation 0.55 |
| Pressure Release Technique GROUP | Changes in the State Anxiety | value at post-treatment minus value at baseline | 1.59 units on a scale | Standard Deviation 1.5 |
| Pressure Release Technique GROUP | Changes in the State Anxiety | value at 3 months later minus value at baseline | 1.53 units on a scale | Standard Deviation 1.4 |
| Pressure Release Technique GROUP | Changes in the State Anxiety | value at 3 months later minus value at post-treatm | -0.05 units on a scale | Standard Deviation 1.09 |
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
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Simulation GROUP | Changes in the State Depression | value at post-treatment minus value at baseline | 0.25 units on a scale | Standard Deviation 0.68 |
| Sham Simulation GROUP | Changes in the State Depression | value at 3 months later minus value at baseline | 0.10 units on a scale | Standard Deviation 0.6 |
| Sham Simulation GROUP | Changes in the State Depression | value at 3 months later minus value at post-treatm | -0.15 units on a scale | Standard Deviation 0.43 |
| Pressure Release Technique GROUP | Changes in the State Depression | value at post-treatment minus value at baseline | 0.74 units on a scale | Standard Deviation 0.74 |
| Pressure Release Technique GROUP | Changes in the State Depression | value at 3 months later minus value at baseline | 0.75 units on a scale | Standard Deviation 0.85 |
| Pressure Release Technique GROUP | Changes in the State Depression | value at 3 months later minus value at post-treatm | 0.01 units on a scale | Standard Deviation 0.5 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
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.
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Simulation GROUP | Changes in the Trait Anxiety | value at post-treatment minus value at baseline | -0.02 units on a scale | Standard Deviation 0.34 |
| Sham Simulation GROUP | Changes in the Trait Anxiety | value at 3 months later minus value at baseline | -0.22 units on a scale | Standard Deviation 0.67 |
| Sham Simulation GROUP | Changes in the Trait Anxiety | value at 3 months later minus value at post-treatm | -0.20 units on a scale | Standard Deviation 0.73 |
| Pressure Release Technique GROUP | Changes in the Trait Anxiety | value at post-treatment minus value at baseline | 0.68 units on a scale | Standard Deviation 1.36 |
| Pressure Release Technique GROUP | Changes in the Trait Anxiety | value at 3 months later minus value at post-treatm | -0.09 units on a scale | Standard Deviation 0.79 |
| Pressure Release Technique GROUP | Changes in the Trait Anxiety | value at 3 months later minus value at baseline | 0.59 units on a scale | Standard Deviation 1.26 |
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
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Simulation GROUP | Changes in the Trait Depression | value at post-treatment minus value at baseline | 0.15 units on a scale | Standard Deviation 0.4 |
| Sham Simulation GROUP | Changes in the Trait Depression | value at 3 months later minus value at baseline | 0.07 units on a scale | Standard Deviation 0.25 |
| Sham Simulation GROUP | Changes in the Trait Depression | value at 3 months later minus value at post-treatm | -0.07 units on a scale | Standard Deviation 0.3 |
| Pressure Release Technique GROUP | Changes in the Trait Depression | value at post-treatment minus value at baseline | 0.30 units on a scale | Standard Deviation 0.6 |
| Pressure Release Technique GROUP | Changes in the Trait Depression | value at 3 months later minus value at baseline | 0.36 units on a scale | Standard Deviation 0.61 |
| Pressure Release Technique GROUP | Changes in the Trait Depression | value at 3 months later minus value at post-treatm | 0.06 units on a scale | Standard Deviation 0.76 |
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.
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Simulation GROUP | Changes of Pain Pressure Thresholds Anterior Temporalis | value at post-treatment minus value at baseline | -0.21 kgf/cm^2 | Standard Deviation 0.36 |
| Sham Simulation GROUP | Changes of Pain Pressure Thresholds Anterior Temporalis | value at 3 months later minus value at baseline | -0.12 kgf/cm^2 | Standard Deviation 0.24 |
| Sham Simulation GROUP | Changes of Pain Pressure Thresholds Anterior Temporalis | value at 3 months later minus value at post-treatm | 0.09 kgf/cm^2 | Standard Deviation 0.38 |
| Pressure Release Technique GROUP | Changes of Pain Pressure Thresholds Anterior Temporalis | value at post-treatment minus value at baseline | -0.48 kgf/cm^2 | Standard Deviation 0.81 |
| Pressure Release Technique GROUP | Changes of Pain Pressure Thresholds Anterior Temporalis | value at 3 months later minus value at baseline | -0.40 kgf/cm^2 | Standard Deviation 0.69 |
| Pressure Release Technique GROUP | Changes of Pain Pressure Thresholds Anterior Temporalis | value at 3 months later minus value at post-treatm | 0.08 kgf/cm^2 | Standard Deviation 0.53 |
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.
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Simulation GROUP | Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid | value at post-treatment minus value at baseline | -0.14 kgf/cm^2 | Standard Deviation 0.33 |
| Sham Simulation GROUP | Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid | value at 3 months later minus value at baseline | -0.08 kgf/cm^2 | Standard Deviation 0.21 |
| Sham Simulation GROUP | Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid | value at 3 months later minus value at post-treatm | 0.06 kgf/cm^2 | Standard Deviation 0.26 |
| Pressure Release Technique GROUP | Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid | value at post-treatment minus value at baseline | -0.22 kgf/cm^2 | Standard Deviation 0.48 |
| Pressure Release Technique GROUP | Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid | value at 3 months later minus value at baseline | -0.33 kgf/cm^2 | Standard Deviation 0.7 |
| Pressure Release Technique GROUP | Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid | value at 3 months later minus value at post-treatm | -0.11 kgf/cm^2 | Standard Deviation 0.64 |
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.
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Simulation GROUP | Changes of Pain Pressure Thresholds Superficial Masseter | value at 3 months later minus value at post-treatm | 0.02 kgf/cm^2 | Standard Deviation 0.22 |
| Sham Simulation GROUP | Changes of Pain Pressure Thresholds Superficial Masseter | value at post-treatment minus value at baseline | -0.23 kgf/cm^2 | Standard Deviation 0.37 |
| Sham Simulation GROUP | Changes of Pain Pressure Thresholds Superficial Masseter | value at 3 months later minus value at baseline | -0.21 kgf/cm^2 | Standard Deviation 0.44 |
| Pressure Release Technique GROUP | Changes of Pain Pressure Thresholds Superficial Masseter | value at post-treatment minus value at baseline | -0.28 kgf/cm^2 | Standard Deviation 0.66 |
| Pressure Release Technique GROUP | Changes of Pain Pressure Thresholds Superficial Masseter | value at 3 months later minus value at baseline | -0.36 kgf/cm^2 | Standard Deviation 0.59 |
| Pressure Release Technique GROUP | Changes of Pain Pressure Thresholds Superficial Masseter | value at 3 months later minus value at post-treatm | -0.09 kgf/cm^2 | Standard Deviation 0.54 |
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.
Time frame: Change from baseline in the scale at post-treatment and at 3 months later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Simulation GROUP | Changes of Pain Pressure Thresholds Upper Trapezius | value at post-treatment minus value at baseline | -0.21 kgf/cm^2 | Standard Deviation 0.36 |
| Sham Simulation GROUP | Changes of Pain Pressure Thresholds Upper Trapezius | value at 3 months later minus value at baseline | -0.12 kgf/cm^2 | Standard Deviation 0.24 |
| Sham Simulation GROUP | Changes of Pain Pressure Thresholds Upper Trapezius | value at 3 months later minus value at post-treatm | 0.09 kgf/cm^2 | Standard Deviation 0.38 |
| Pressure Release Technique GROUP | Changes of Pain Pressure Thresholds Upper Trapezius | value at post-treatment minus value at baseline | -0.48 kgf/cm^2 | Standard Deviation 0.81 |
| Pressure Release Technique GROUP | Changes of Pain Pressure Thresholds Upper Trapezius | value at 3 months later minus value at baseline | -0.40 kgf/cm^2 | Standard Deviation 0.69 |
| Pressure Release Technique GROUP | Changes of Pain Pressure Thresholds Upper Trapezius | value at 3 months later minus value at post-treatm | 0.08 kgf/cm^2 | Standard Deviation 0.53 |