Back to resultsEffects of Diacutaneous Fibrolysis Over Neuromuscular Response
Primary Purpose
Myofascial Pain Syndrome, Contraction
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diacutaneous fibrolysis
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Neuromuscular response, diacutaneous fibrolysis
Eligibility Criteria
Exclusion Criteria:
- Muscle injury in the last two months
- To not understand the study orders
- Suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol
Sites / Locations
- Albert Pérez-Bellmunt
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Diacutaneous fibrolysis
Control
Arm Description
Outcomes
Primary Outcome Measures
Delay time change
Time between an electric impulse and 10% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).
Contraction time change
Time between 10% and 90% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).
Sustain time change
time between 50% of the contraction and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).
Relaxation time change
time between 90% and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).
Maximal displacement change
Maximal displacement of the muscle after being excited with an electric impulse, using an electromyography test (miliseconds).
Stiffness change
Resistance to an external force that deforms its initial shape, using a "Myoton" (Newtons/metre).
Elasticity change
Capacity to recover its initial shape after the removal of the external force that lead to its deformation, using a "Myoton" (logarithmic decrement of a tissue's natural oscillation).
Relaxation change
Time for a muscle to recover its shape from deformation after the removal of an external force, using a "Myoton" (miliseconds).
Secondary Outcome Measures
Gastrocnemious strength change
Isometric strength of the gastrocnemious muscles using a handheld dynamometer "microFET 2" (newtons).
Full Information
NCT ID
NCT03963674
First Posted
May 20, 2019
Last Updated
May 23, 2019
Sponsor
Universitat Internacional de Catalunya
1. Study Identification
Unique Protocol Identification Number
NCT03963674
Brief Title
Effects of Diacutaneous Fibrolysis Over Neuromuscular Response
Official Title
Effects of Diacutaneous Fibrolysis Over the Gastrocnemious Neuromuscular Response
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
February 5, 2019 (Actual)
Study Completion Date
June 5, 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
5. Study Description
Brief Summary
The study consists in evaluating the neuromuscular response of the gastrocnemious muscles before and after a diacutaneous fibrolysis over the gastrocnemious muscles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome, Contraction
Keywords
Neuromuscular response, diacutaneous fibrolysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diacutaneous fibrolysis
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Diacutaneous fibrolysis
Intervention Description
Diacutaneous fibrolysis over the gastrocnemious muscles
Primary Outcome Measure Information:
Title
Delay time change
Description
Time between an electric impulse and 10% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).
Time Frame
4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
Title
Contraction time change
Description
Time between 10% and 90% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).
Time Frame
4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
Title
Sustain time change
Description
time between 50% of the contraction and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).
Time Frame
4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
Title
Relaxation time change
Description
time between 90% and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).
Time Frame
4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
Title
Maximal displacement change
Description
Maximal displacement of the muscle after being excited with an electric impulse, using an electromyography test (miliseconds).
Time Frame
4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
Title
Stiffness change
Description
Resistance to an external force that deforms its initial shape, using a "Myoton" (Newtons/metre).
Time Frame
2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
Title
Elasticity change
Description
Capacity to recover its initial shape after the removal of the external force that lead to its deformation, using a "Myoton" (logarithmic decrement of a tissue's natural oscillation).
Time Frame
2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
Title
Relaxation change
Description
Time for a muscle to recover its shape from deformation after the removal of an external force, using a "Myoton" (miliseconds).
Time Frame
2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
Secondary Outcome Measure Information:
Title
Gastrocnemious strength change
Description
Isometric strength of the gastrocnemious muscles using a handheld dynamometer "microFET 2" (newtons).
Time Frame
8 minutes before the intervention, 1 minute after the intervention and 30 minutes later
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
Exclusion Criteria:
Muscle injury in the last two months
To not understand the study orders
Suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol
Facility Information:
Facility Name
Albert Pérez-Bellmunt
City
Sant Cugat del Vallès
State/Province
Barcelona
ZIP/Postal Code
08017
Country
Spain
12. IPD Sharing Statement
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Effects of Diacutaneous Fibrolysis Over Neuromuscular Response
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