- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04778293
Effects of Diacutaneous Fibrolysis on Passive Neuromuscular Response
Effects of Diacutaneous Fibrolysis on Passive Neuromuscular Response and Mechanosensitivity on Posterior Muscular Chain of Lower Limb in Athletes.
Diacutaneous fibrolysis is a physiotherapeutic instrumental technique, used to treat musculoskeletal conditions causing pain and/or movement restriction . It is applied by means of metallic hooks, ending in a spatula with beveled edges, that seems to allow a better pressure distribution on the skin and a deeper and more precise application, compared to the manual approach.
Recent studies indicate positive responses regrading pain intensity decrease in sports people suffering anterior knee pain, improving range of motion in subacromial impingement syndrome, improving sensory conductivity in symptomatic patients with carpal tunnel syndrome, decreased pain in patients with chronic epicondialgia or improveing function athletes with anterior knee pain.
However, the specific action mechanism, have not been investigated in depth yet. Clinical studies show improvements in strength, pain intensity, range of motion, or function. But whether if this effect is produced by changes in tissue tension or by reflexes effects, as has been suggested before, still unclear. There are no studies evaluating its effects on posterior muscular chain of lower extremity in athletes, where FD effects on neuromuscular response could be more evident due to the overload involved on this area.
Thus, the aim of this study is to evaluate the immediate, and after 30 minutes, effects of a single diacutaneous fibrolysis session on contractile and viscoelastic muscle properties and mechanosensitibity by means of tensiomyography, myotonometry and algometry on posterior muscular chain of lower limb in athletes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Diacutaneous fibrolysis is a physiotherapeutic instrumental technique, used to treat musculoskeletal conditions causing pain and/or movement restriction . It is applied by means of metallic hooks, ending in a spatula with beveled edges, that seems to allow a better pressure distribution on the skin and a deeper and more precise application, compared to the manual approach.
Recent studies indicate positive responses regrading pain intensity decrease in sports people suffering anterior knee pain, improving range of motion in subacromial impingement syndrome, improving sensory conductivity in symptomatic patients with carpal tunnel syndrome, decreased pain in patients with chronic epicondialgia or improveing function athletes with anterior knee pain.
However, the specific action mechanism, have not been investigated in depth yet. Clinical studies show improvements in strength, pain intensity, range of motion, or function. But whether if this effect is produced by changes in tissue tension or by reflexes effects, as has been suggested before, still unclear. There are no studies evaluating its effects on posterior muscular chain of lower extremity in athletes, where FD effects on neuromuscular response could be more evident due to the overload involved on this area.
Thus, the aim of this study is to evaluate the immediate, and after 30 minutes, effects of a single diacutaneous fibrolysis session on contractile and viscoelastic muscle properties and mechanosensitibity on posterior muscular chain of lower limb in athletes.
Design. A randomized controlled trial with blind evaluator. Randomization. Between lower extremities of each subject (Random.org). Regardless of its own dominance, diacutaneous fibrolysis will be applied to de following muscles and intermuscular septums: gluteus maixmus, biceps femoris and semitendinosus to de lower experimental limb. The other extremity will not be treat (control limb).
Sample recruitment. Athletes from UIC university community, who compete officially or institutionally, whether they are federated or recorded in a sport official register where the predominant activity focuses on the lower train (athletics, cycling, football, rugby...).
Procedure. The anthropometric data will be collected at the beginning of the study. The outcome assessment will be performed by a blinded evaluator at the baseline, immediately after the technique application and 30 minutes after.
An experienced physiotherapist in the diacutaneous fibrolysis technique will apply the treatment to the lower limb, previously randomized, in the following musculature and intermuscular septums: quadratus lumbar, gluteus maixum, biceps femoris and semitendinosus. Intervention procedure will last about 10-15 minutes
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aida C Cadellans-Arróniz, MsC
- Phone Number: 635246977
- Email: acadellans@uic.es
Study Locations
-
-
Barcelona
-
Sant Cugat Del Vallès, Barcelona, Spain, 08195
- Recruiting
- Universitat Internacional de Catalunya
-
Contact:
- Aida C Cadellans-Arróniz, MsC
- Phone Number: 635246977
- Email: acadellans@uic.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants must sign and have informed consent. They must have shortening of the hamstring muscles (being considered itself as such <160º in the Passive Knee Extension test as a main inclusion criteria.
Exclusion Criteria:
- Will involve any contraindication related to diacutaneous fibrolysis such us poor skin or trophic condition, taking anticoagulants, inflammatory process or recent injury).
Study Plan
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 Group
No intervention
|
|
Experimental: Experimental Group
An experienced physiotherapist in the diacutaneous fibrolysis technique will apply the treatment to the lower limb, previously randomized (random.org), in the following musculature and intermuscular septums: quadratus lumbar, gluteus maixum, biceps femoris and semitendinosus.
Intervention procedure will last about 10-15 minutes
|
An experienced physiotherapist in the diacutaneous fibrolysis technique will apply the treatment to the lower limb, previously randomized, in the following musculature and intermuscular septums: quadratus lumbar, gluteus maixum, biceps femoris and semitendinosus.
Intervention procedure will last about 10-15 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contraction time changes
Time Frame: at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.
|
Contraction time as a time between 10% and 90% of the contraction (ms). It will be assessed by tensomyography. Tensomyography is an evaluation method which allows to measure contractile muscle properties in isometric conditions, through an external electrical stimulus, of controlled intensity. It has a high of reliability (r = 0.93) and reproducibility. Tensomyography data for gluteus maximus, biceps femoris and semitendinosus, will be assessed, following protocols used in previous studies. |
at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.
|
Relaxation time changes
Time Frame: at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.
|
Relaxation time as a time between 90% and 50% of the relaxation (ms). It will be assessed by tensomyography. Tensomyography is an evaluation method which allows to measure contractile muscle properties in isometric conditions, through an external electrical stimulus, of controlled intensity. It has a high of reliability (r = 0.93) and reproducibility. Tensomyography data for gluteus maximus, biceps femoris and semitendinosus, will be assessed, following protocols used in previous studies. |
at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.
|
Maximal Displacement changes
Time Frame: at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.
|
Maximal displacement of the muscle contraction (mm). It will be assessed by tensomyography. Tensomyography is an evaluation method which allows to measure contractile muscle properties in isometric conditions, through an external electrical stimulus, of controlled intensity. It has a high of reliability (r = 0.93) and reproducibility. Tensomyography data for gluteus maximus, biceps femoris and semitendinosus, will be assessed, following protocols used in previous studies. |
at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.
|
Contraction velocity changes
Time Frame: at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.
|
Contraction velocity it is described as a change in Dm over time between 10% and 90% of the contraction (mm/s). It will be assessed by tensomyography. Tensomyography is an evaluation method which allows to measure contractile muscle properties in isometric conditions, through an external electrical stimulus, of controlled intensity. It has a high of reliability (r = 0.93) and reproducibility. Tensomyography data for gluteus maximus, biceps femoris and semitendinosus, will be assessed, following protocols used in previous studies. |
at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.
|
Muscle tone changes
Time Frame: at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.
|
Myotonometry is an assessing method for the viscoelastic characteristics of a resting muscle. It releases a mechanical impulse and provides quantitative values about muscle tone (Hz). This data will be collected at the same points used on tensiomyography . This data will be collected at the same points used on tensiomyography |
at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.
|
Muscle Stiffness changes
Time Frame: at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.
|
Muscle Stiffness changes will be assessed by myotonometry is an assessing method for the viscoelastic characteristics of a resting muscle.
It releases a mechanical impulse and provides quantitative values about muscle stiffness (N/m).
This data will be collected at the same points used on tensiomyography .
|
at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.
|
Mechanosensibility changes
Time Frame: at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.
|
Pressure algometry is a method that quantifies (Kg) mechanosensitivity, applying a mechanical stimulus of progressive compression on a point located in the body. In several studies, the trigger points, are the ones used for this purpose. Algometers are devices of easy accessibility, and is a method that has shown high reliability (r = 0.80) . This data will be collected at the same points used on tensomyography and myotonometry. This data will be collected at the same points used on tensiomyography |
at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIS-2020-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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