Trial Outcomes & Findings for The Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder (NCT NCT03619889)

NCT ID: NCT03619889

Last Updated: 2020-03-20

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 74 participants
• Primary outcome timeframe: Change from baseline in the scale at post-treatment and at 3 months later
• Results posted on: 2020-03-20

Participant Flow

Participant milestones

Measure	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.	Manual Pressure Release Technique GROUP 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).
Overall Study STARTED	37	37
Overall Study COMPLETED	35	37
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder

Baseline characteristics by cohort

Measure	Control Group n=35 Participants 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.	Intervention Group n=37 Participants 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 n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	31 Participants n=7 Participants	65 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Spain	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Sham Simulation GROUP n=35 Participants 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.	Pressure Release Technique GROUP n=37 Participants 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).
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	-2.30 units on a scale Standard Deviation 1.16
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	-2.84 units on a scale Standard Deviation 1.94
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	-0.54 units on a scale Standard Deviation 0.31

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sham Simulation GROUP n=35 Participants 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.	Pressure Release Technique GROUP n=37 Participants 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).
Changes of Pain Pressure Thresholds Anterior Temporalis value at post-treatment minus value at baseline	-0.21 kgf/cm^2 Standard Deviation 0.36	-0.48 kgf/cm^2 Standard Deviation 0.81
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	-0.40 kgf/cm^2 Standard Deviation 0.69
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	0.08 kgf/cm^2 Standard Deviation 0.53

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sham Simulation GROUP n=35 Participants 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.	Pressure Release Technique GROUP n=37 Participants 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).
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	-4.27 mm Standard Deviation 6.39
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	-5.22 mm Standard Deviation 6.68
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	-0.95 mm Standard Deviation 2.70

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sham Simulation GROUP n=35 Participants 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.	Pressure Release Technique GROUP n=37 Participants 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).
Changes in the Neck Disability value at post-treatment minus value at baseline	1.09 units on a scale Standard Deviation 2.67	5.78 units on a scale Standard Deviation 5.45
Changes in the Neck Disability value at 3 months later minus value at baseline	0.40 units on a scale Standard Deviation 1.61	5.40 units on a scale Standard Deviation 5.31
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	-0.38 units on a scale Standard Deviation 4.08

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sham Simulation GROUP n=35 Participants 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.	Pressure Release Technique GROUP n=37 Participants 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).
Changes in the Kinesiophobia value at post-treatment minus value at baseline	1.80 units on a scale Standard Deviation 2.65	5.24 units on a scale Standard Deviation 4.49
Changes in the Kinesiophobia value at 3 months later minus value at baseline	1.83 units on a scale Standard Deviation 3.30	5.92 units on a scale Standard Deviation 4.94
Changes in the Kinesiophobia value at 3 months later minus value at post-treatm	0.03 units on a scale Standard Deviation 2.63	0.68 units on a scale Standard Deviation 2.43

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sham Simulation GROUP n=35 Participants 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.	Pressure Release Technique GROUP n=37 Participants 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).
Changes in the Catastrophizing value at post-treatment minus value at baseline	2.14 units on a scale Standard Deviation 3.40	9.92 units on a scale Standard Deviation 7.68
Changes in the Catastrophizing value at 3 months later minus value at baseline	0.80 units on a scale Standard Deviation 3.53	9.84 units on a scale Standard Deviation 7.50
Changes in the Catastrophizing value at 3 months later minus value at post-treatm	-1.34 units on a scale Standard Deviation 3.20	-0.08 units on a scale Standard Deviation 4.67

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sham Simulation GROUP n=35 Participants 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.	Pressure Release Technique GROUP n=37 Participants 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).
Changes in the State Anxiety value at post-treatment minus value at baseline	0.30 units on a scale Standard Deviation 0.93	1.59 units on a scale Standard Deviation 1.50
Changes in the State Anxiety value at 3 months later minus value at baseline	0.22 units on a scale Standard Deviation 0.82	1.53 units on a scale Standard Deviation 1.40
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	-0.05 units on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Sham Simulation GROUP n=35 Participants 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.	Pressure Release Technique GROUP n=37 Participants 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).
Changes in the State Depression value at post-treatment minus value at baseline	0.25 units on a scale Standard Deviation 0.68	0.74 units on a scale Standard Deviation 0.74
Changes in the State Depression value at 3 months later minus value at baseline	0.10 units on a scale Standard Deviation 0.60	0.75 units on a scale Standard Deviation 0.85
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	0.01 units on a scale Standard Deviation 0.50

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sham Simulation GROUP n=35 Participants 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.	Pressure Release Technique GROUP n=37 Participants 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).
Changes in the Trait Anxiety value at post-treatment minus value at baseline	-0.02 units on a scale Standard Deviation 0.34	0.68 units on a scale Standard Deviation 1.36
Changes in the Trait Anxiety value at 3 months later minus value at baseline	-0.22 units on a scale Standard Deviation 0.67	0.59 units on a scale Standard Deviation 1.26
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	-0.09 units on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Sham Simulation GROUP n=35 Participants 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.	Pressure Release Technique GROUP n=37 Participants 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).
Changes in the Trait Depression value at post-treatment minus value at baseline	0.15 units on a scale Standard Deviation 0.40	0.30 units on a scale Standard Deviation 0.60
Changes in the Trait Depression value at 3 months later minus value at baseline	0.07 units on a scale Standard Deviation 0.25	0.36 units on a scale Standard Deviation 0.61
Changes in the Trait Depression value at 3 months later minus value at post-treatm	-0.07 units on a scale Standard Deviation 0.30	0.06 units on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sham Simulation GROUP n=35 Participants 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.	Pressure Release Technique GROUP n=37 Participants 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).
Changes of Pain Pressure Thresholds Upper Trapezius value at post-treatment minus value at baseline	-0.21 kgf/cm^2 Standard Deviation 0.36	-0.48 kgf/cm^2 Standard Deviation 0.81
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	-0.40 kgf/cm^2 Standard Deviation 0.69
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	0.08 kgf/cm^2 Standard Deviation 0.53

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sham Simulation GROUP n=35 Participants 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.	Pressure Release Technique GROUP n=37 Participants 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).
Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid value at post-treatment minus value at baseline	-0.14 kgf/cm^2 Standard Deviation 0.33	-0.22 kgf/cm^2 Standard Deviation 0.48
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	-0.33 kgf/cm^2 Standard Deviation 0.70
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	-0.11 kgf/cm^2 Standard Deviation 0.64

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sham Simulation GROUP n=35 Participants 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.	Pressure Release Technique GROUP n=37 Participants 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).
Changes of Pain Pressure Thresholds Superficial Masseter value at post-treatment minus value at baseline	-0.23 kgf/cm^2 Standard Deviation 0.37	-0.28 kgf/cm^2 Standard Deviation 0.66
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	-0.36 kgf/cm^2 Standard Deviation 0.59
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	-0.09 kgf/cm^2 Standard Deviation 0.54

Adverse Events

Sham Simulation GROUP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pressure Pain Technique GROUP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dra. Gema Serrano-Hernanz

Universidad Complutense de Madrid

Phone: 669332986

Email: gema.serrano.hernanz@gmail.com, gemase01@ucm.es

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place