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

• Sponsor: Universidad Complutense de Madrid (Other)
• Overall Status: Completed
• CT.gov ID: NCT03619889
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 3.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myofascial Pain Syndrome; Temporomandibular Disorder	Other: Manual pressure release technique on trigger points.; Other: Sham	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: clinical trial, prospective, randomized and experimental with masking of the statistician and the participantsclinical 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: Oct 1, 2015
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Sep 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: 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.	Other: Sham; A simulated pressure release technique is applied around masticatory and neck muscles.; Other Names: Placebo
Experimental: 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.	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 Names: Myofascial release

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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

8. 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.

9. 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

10. 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.

11. 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.

12. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Mar 16, 2015

More Information

Publications

None provided.

• Responsible Party: Gema Serrano-Hernanz, Principal Investigator, Clinical Professor, Universidad Complutense de Madrid
• ClinicalTrials.gov Identifier: NCT03619889
• Other Study ID Numbers: Geseher
• First Posted: Aug 8, 2018
• Last Update Posted: Mar 20, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gema Serrano-Hernanz, Principal Investigator, Clinical Professor, Universidad Complutense de Madrid: Chronic Pain; Physical Therapy modalities
• Additional relevant MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Myofascial Pain Syndromes; Fibromyalgia

Study Results

Participant Flow

Arm/Group Title	Sham Simulation GROUP	Manual Pressure Release Technique GROUP
Arm/Group 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles.	The Pressure Release 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).
Period Title: Overall Study
STARTED	37	37
COMPLETED	35	37
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Control Group	Intervention Group	Total
Arm/Group 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles.	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).	Total of all reporting groups
Overall Participants	35	37	72
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	34 97.1%	31 83.8%	65 90.3%
>=65 years	1 2.9%	6 16.2%	7 9.7%
Sex: Female, Male (Count of Participants)
Female	31 88.6%	29 78.4%	60 83.3%
Male	4 11.4%	8 21.6%	12 16.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	35 100%	37 100%	72 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Spain	35 100%	37 100%	72 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Simulation GROUP	Pressure Release Technique GROUP
Arm/Group 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles.	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).
Measure Participants	35	37
value at post-treatment minus value at baseline	-1.03 (0.82)	-2.30 (1.16)
value at 3 months later minus value at baseline	-0.77 (0.88)	-2.84 (1.94)
value at 3 months later minus value at post-treatm	0.26 (0.12)	-0.54 (0.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pressure Release Technique GROUP
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Sham Simulation GROUP
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.2
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Simulation GROUP	Pressure Release Technique GROUP
Arm/Group 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles.	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).
Measure Participants	35	37
value at post-treatment minus value at baseline	-0.21 (0.36)	-0.48 (0.81)
value at 3 months later minus value at baseline	-0.12 (0.24)	-0.40 (0.69)
value at 3 months later minus value at post-treatm	0.09 (0.38)	0.08 (0.53)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Simulation GROUP	Pressure Release Technique GROUP
Arm/Group 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles.	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).
Measure Participants	35	37
value at post-treatment minus value at baseline	-0.26 (5.81)	-4.27 (6.39)
value at 3 months later minus value at baseline	-1.09 (6.59)	-5.22 (6.68)
value at 3 months later minus value at post-treatm	-0.83 (1.81)	-0.95 (2.70)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Simulation GROUP	Pressure Release Technique GROUP
Arm/Group 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles.	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).
Measure Participants	35	37
value at post-treatment minus value at baseline	1.09 (2.67)	5.78 (5.45)
value at 3 months later minus value at baseline	0.40 (1.61)	5.40 (5.31)
value at 3 months later minus value at post-treatm	-0.69 (2.48)	-0.38 (4.08)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Simulation GROUP	Pressure Release Technique GROUP
Arm/Group 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles.	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).
Measure Participants	35	37
value at post-treatment minus value at baseline	1.80 (2.65)	5.24 (4.49)
value at 3 months later minus value at baseline	1.83 (3.30)	5.92 (4.94)
value at 3 months later minus value at post-treatm	0.03 (2.63)	0.68 (2.43)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Simulation GROUP	Pressure Release Technique GROUP
Arm/Group 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles.	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).
Measure Participants	35	37
value at post-treatment minus value at baseline	2.14 (3.40)	9.92 (7.68)
value at 3 months later minus value at baseline	0.80 (3.53)	9.84 (7.50)
value at 3 months later minus value at post-treatm	-1.34 (3.20)	-0.08 (4.67)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Simulation GROUP	Pressure Release Technique GROUP
Arm/Group 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles.	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).
Measure Participants	35	37
value at post-treatment minus value at baseline	0.30 (0.93)	1.59 (1.50)
value at 3 months later minus value at baseline	0.22 (0.82)	1.53 (1.40)
value at 3 months later minus value at post-treatm	-0.08 (0.55)	-0.05 (1.09)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Simulation GROUP	Pressure Release Technique GROUP
Arm/Group 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles.	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).
Measure Participants	35	37
value at post-treatment minus value at baseline	0.25 (0.68)	0.74 (0.74)
value at 3 months later minus value at baseline	0.10 (0.60)	0.75 (0.85)
value at 3 months later minus value at post-treatm	-0.15 (0.43)	0.01 (0.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pressure Release Technique GROUP
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Sham Simulation GROUP, Pressure Release Technique GROUP
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.65
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Simulation GROUP	Pressure Release Technique GROUP
Arm/Group 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles.	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).
Measure Participants	35	37
value at post-treatment minus value at baseline	-0.02 (0.34)	0.68 (1.36)
value at 3 months later minus value at baseline	-0.22 (0.67)	0.59 (1.26)
value at 3 months later minus value at post-treatm	-0.20 (0.73)	-0.09 (0.79)

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Simulation GROUP	Pressure Release Technique GROUP
Arm/Group 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles.	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).
Measure Participants	35	37
value at post-treatment minus value at baseline	0.15 (0.40)	0.30 (0.60)
value at 3 months later minus value at baseline	0.07 (0.25)	0.36 (0.61)
value at 3 months later minus value at post-treatm	-0.07 (0.30)	0.06 (0.76)

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Simulation GROUP	Pressure Release Technique GROUP
Arm/Group 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles.	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).
Measure Participants	35	37
value at post-treatment minus value at baseline	-0.21 (0.36)	-0.48 (0.81)
value at 3 months later minus value at baseline	-0.12 (0.24)	-0.40 (0.69)
value at 3 months later minus value at post-treatm	0.09 (0.38)	0.08 (0.53)

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Simulation GROUP	Pressure Release Technique GROUP
Arm/Group 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles.	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).
Measure Participants	35	37
value at post-treatment minus value at baseline	-0.14 (0.33)	-0.22 (0.48)
value at 3 months later minus value at baseline	-0.08 (0.21)	-0.33 (0.70)
value at 3 months later minus value at post-treatm	0.06 (0.26)	-0.11 (0.64)

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Simulation GROUP	Pressure Release Technique GROUP
Arm/Group 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. Sham: A simulated pressure release technique is applied around masticatory and neck muscles.	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).
Measure Participants	35	37
value at post-treatment minus value at baseline	-0.23 (0.37)	-0.28 (0.66)
value at 3 months later minus value at baseline	-0.21 (0.44)	-0.36 (0.59)
value at 3 months later minus value at post-treatm	0.02 (0.22)	-0.09 (0.54)

Adverse Events

Time Frame	adverse events were not monitored/assessed
Adverse Event Reporting Description	adverse events were not monitored/assessed
Arm/Group Title	Sham Simulation GROUP		Pressure Pain Technique GROUP
Arm/Group Description	simulation of the pressure release technique		pressure release technique consists in aply pressure on muscular trigger points during 90 sec until the tissue barrier releases
All Cause Mortality
	Sham Simulation GROUP		Pressure Pain Technique GROUP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Sham Simulation GROUP		Pressure Pain Technique GROUP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Sham Simulation GROUP		Pressure Pain Technique GROUP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.