Back to resultsMyosfascial Trigger-Points and Effects on Neuromuscular Response
Primary Purpose
Myofascial Trigger Point Pain
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pressure Release
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Trigger Point Pain
Eligibility Criteria
Inclusion Criteria:
- Subjets with both active or latent Myosfascial Trigger Points
Exclusion Criteria:
- Pregnant women
- Musculoskeletal problems in the last month
- Surgical interventions in he knee, hip, ankle, back or neck in tha last 6 months
- Psychological or nervous alterations
- Uncomprehension of the study protocol
Sites / Locations
- Universitat Internacional de Catalunya
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control arm
Pressure Release
Arm Description
No intervention
Digitopressure treatment of the Myosfascial Trigger Points
Outcomes
Primary Outcome Measures
change of neuromuscular stiffness of the gastrocnemious muscles
biomechanical property of a muscle that characterizes the resistance to an external force that deforms its initial shape, using a "Myoton".
change of elasticity of the gastrocnemious muscles
Biomechanical property of a muscle that characterizes the ability to recover its initial shape after the removal of the external force that lead to its deformation, using a "Myoton".
change of relaxation of the gastrocnemious muscles
Time for a muscle to recover its shape from deformation after the removal of an external force, using a "Myoton".
Secondary Outcome Measures
change of active dorsiflexion ROM
Active range of movement of the dorsiflexion of the ankle, using an inclinometer (degrees).
change of pasive dorsiflexion ROM
Pasive range of movement of the dorsiflexion of the ankle, using an inclinometer (degrees).
change of gastrocnemious strength
Isometric strength of the gastrocnemious muscles using a handheld dynamometer "microFET 2" (newtons).
change of pain intensity
How much pressure needs to be applied to cause pain
change of pressure-pain threshold
How much pain the pacient reports while a pressure of 1kg/cm²/s is being applied over his gastrocnemious muscle
Full Information
NCT ID
NCT03941054
First Posted
May 3, 2019
Last Updated
May 6, 2019
Sponsor
Universitat Internacional de Catalunya
1. Study Identification
Unique Protocol Identification Number
NCT03941054
Brief Title
Myosfascial Trigger-Points and Effects on Neuromuscular Response
Official Title
Treatment of Myosfascial Trigger-Points of Gastrocnemius and Its Effects on the Neuromuscular Response
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
June 7, 2019 (Anticipated)
Study Completion Date
June 7, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to analyze the effects of the treatment of the Myosfascial Trigger-Points detected in the gastrocnemius muscles on the neuromuscular response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Trigger Point Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Pressure Release
Arm Type
Experimental
Arm Description
Digitopressure treatment of the Myosfascial Trigger Points
Intervention Type
Other
Intervention Name(s)
Pressure Release
Intervention Description
Subjets receive digitopressure during 90 seconds for the treatment of the Myosfascial Trigger Points
Primary Outcome Measure Information:
Title
change of neuromuscular stiffness of the gastrocnemious muscles
Description
biomechanical property of a muscle that characterizes the resistance to an external force that deforms its initial shape, using a "Myoton".
Time Frame
10 minutes before the intervention, and 1 minute after the intervention
Title
change of elasticity of the gastrocnemious muscles
Description
Biomechanical property of a muscle that characterizes the ability to recover its initial shape after the removal of the external force that lead to its deformation, using a "Myoton".
Time Frame
10 minutes before the intervention, and 1 minute after the intervention
Title
change of relaxation of the gastrocnemious muscles
Description
Time for a muscle to recover its shape from deformation after the removal of an external force, using a "Myoton".
Time Frame
10 minutes before the intervention, and 1 minute after the intervention
Secondary Outcome Measure Information:
Title
change of active dorsiflexion ROM
Description
Active range of movement of the dorsiflexion of the ankle, using an inclinometer (degrees).
Time Frame
4 minutes before the intervention, and 6 minute after the intervention
Title
change of pasive dorsiflexion ROM
Description
Pasive range of movement of the dorsiflexion of the ankle, using an inclinometer (degrees).
Time Frame
2 minutes before the intervention, and 8 minute after the intervention
Title
change of gastrocnemious strength
Description
Isometric strength of the gastrocnemious muscles using a handheld dynamometer "microFET 2" (newtons).
Time Frame
5 minutes before the intervention, and 5 minute after the intervention
Title
change of pain intensity
Description
How much pressure needs to be applied to cause pain
Time Frame
8 minutes before the intervention, and 2 minute after the intervention
Title
change of pressure-pain threshold
Description
How much pain the pacient reports while a pressure of 1kg/cm²/s is being applied over his gastrocnemious muscle
Time Frame
7 minutes before the intervention, and 3 minute after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjets with both active or latent Myosfascial Trigger Points
Exclusion Criteria:
Pregnant women
Musculoskeletal problems in the last month
Surgical interventions in he knee, hip, ankle, back or neck in tha last 6 months
Psychological or nervous alterations
Uncomprehension of the study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Pérez-Bellmunt, PhD
Organizational Affiliation
Anatomy lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat Internacional de Catalunya
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Myosfascial Trigger-Points and Effects on Neuromuscular Response
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