| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | Change from baseline in the scale at post-treatment and at 3 months later | | | | ID | Title | Description |
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| OG000 | 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles. | | OG001 | 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. 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). |
| | | Title | Denominators | Categories |
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| value at post-treatment minus value at baseline | | | Title | Measurements |
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| - OG000-1.03± 0.82
- OG001-2.30± 1.16
|
| | value at 3 months later minus value at baseline | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | t-test, 2 sided | | <0.001 | | | | | | | | | | | | | | Superiority | | | | | t-test, 2 sided | | <0.001 | | Mean Difference (Net) |
|
| 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. | | Posted | | Mean | Standard Deviation | kgf/cm^2 | | Change from baseline in the scale at post-treatment and at 3 months later | | | | ID | Title | Description |
|---|
| OG000 | 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles. | | OG001 | 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. 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). |
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| 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. | | Posted | | Mean | Standard Deviation | mm | | Change from baseline in the scale at post-treatment and at 3 months later | | | | ID | Title | Description |
|---|
| OG000 | 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles. | | OG001 | 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. 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). |
| |
| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | Change from baseline in the scale at post-treatment and at 3 months later | | | | ID | Title | Description |
|---|
| OG000 | 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles. | | OG001 | 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. 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). |
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| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | Change from baseline in the scale at post-treatment and at 3 months later | | | | ID | Title | Description |
|---|
| OG000 | 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles. | | OG001 | 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. 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). |
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| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | Change from baseline in the scale at post-treatment and at 3 months later | | | | ID | Title | Description |
|---|
| OG000 | 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles. | | OG001 | 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. 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). |
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| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | Change from baseline in the scale at post-treatment and at 3 months later | | | | ID | Title | Description |
|---|
| OG000 | 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles. | | OG001 | 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. 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). |
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| 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 | | Posted | | Mean | Standard Deviation | units on a scale | | Change from baseline in the scale at post-treatment and at 3 months later | | | | ID | Title | Description |
|---|
| OG000 | 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles. | | OG001 | 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. 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). |
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| 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. | | Posted | | Mean | Standard Deviation | units on a scale | | Change from baseline in the scale at post-treatment and at 3 months later | | | | ID | Title | Description |
|---|
| OG000 | 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles. | | OG001 | 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. 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). |
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| 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 | | Posted | | Mean | Standard Deviation | units on a scale | | Change from baseline in the scale at post-treatment and at 3 months later | | | | ID | Title | Description |
|---|
| OG000 | 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles. | | OG001 | 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. 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). |
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| 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. | | Posted | | Mean | Standard Deviation | kgf/cm^2 | | Change from baseline in the scale at post-treatment and at 3 months later | | | | ID | Title | Description |
|---|
| OG000 | 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles. | | OG001 | 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. 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). |
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| 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. | | Posted | | Mean | Standard Deviation | kgf/cm^2 | | Change from baseline in the scale at post-treatment and at 3 months later | | | | ID | Title | Description |
|---|
| OG000 | 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles. | | OG001 | 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. 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). |
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| 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. | | Posted | | Mean | Standard Deviation | kgf/cm^2 | | Change from baseline in the scale at post-treatment and at 3 months later | | | | ID | Title | Description |
|---|
| OG000 | 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles. | | OG001 | 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. 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). |
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