- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03963674
Effects of Diacutaneous Fibrolysis Over Neuromuscular Response
May 23, 2019 updated by: Albert Pérez Bellmunt, Universitat Internacional de Catalunya
Effects of Diacutaneous Fibrolysis Over the Gastrocnemious Neuromuscular Response
The study consists in evaluating the neuromuscular response of the gastrocnemious muscles before and after a diacutaneous fibrolysis over the gastrocnemious muscles.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Barcelona
-
Sant Cugat del Vallès, Barcelona, Spain, 08017
- Albert Pérez-Bellmunt
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Diacutaneous fibrolysis
|
Diacutaneous fibrolysis over the gastrocnemious muscles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delay time change
Time Frame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
|
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).
|
4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
|
|
Contraction time change
Time Frame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
|
Time between 10% and 90% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).
|
4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
|
|
Sustain time change
Time Frame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
|
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).
|
4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
|
|
Relaxation time change
Time Frame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
|
time between 90% and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).
|
4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
|
|
Maximal displacement change
Time Frame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
|
Maximal displacement of the muscle after being excited with an electric impulse, using an electromyography test (miliseconds).
|
4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
|
|
Stiffness change
Time Frame: 2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
|
Resistance to an external force that deforms its initial shape, using a "Myoton" (Newtons/metre).
|
2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
|
|
Elasticity change
Time Frame: 2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
|
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).
|
2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
|
|
Relaxation change
Time Frame: 2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
|
Time for a muscle to recover its shape from deformation after the removal of an external force, using a "Myoton" (miliseconds).
|
2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastrocnemious strength change
Time Frame: 8 minutes before the intervention, 1 minute after the intervention and 30 minutes later
|
Isometric strength of the gastrocnemious muscles using a handheld dynamometer "microFET 2" (newtons).
|
8 minutes before the intervention, 1 minute after the intervention and 30 minutes later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2019
Primary Completion (Actual)
February 5, 2019
Study Completion (Anticipated)
June 5, 2019
Study Registration Dates
First Submitted
May 20, 2019
First Submitted That Met QC Criteria
May 23, 2019
First Posted (Actual)
May 28, 2019
Study Record Updates
Last Update Posted (Actual)
May 28, 2019
Last Update Submitted That Met QC Criteria
May 23, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocol 5
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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