search
Back to results

Effects of Diacutaneous Fibrolysis on Flexibility and Active Neuromuscular Response

Primary Purpose

Hamstring Contractures

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diacutaneous fibrolysis
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hamstring Contractures focused on measuring Diacutaneous fibrolysis, Physiotherapy, Neuromuscular response

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Athletes
  • <160º in the Passive Knee Extension test
  • Participants must sign and have informed consent.

Exclusion Criteria:

  • Poor skin
  • Trophic condition
  • Taking anticoagulants
  • Inflammatory process
  • Recent musculoskeletal lower limb injury (< 6 month)

Sites / Locations

  • Universitat Internacional de CatalunyaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diacutaneous fibrolysis group

Control group

Arm 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. Regardless of its own dominance, diacutaneous fibrolysis will be applied to de following muscles and intermuscular septums: gluteus maximus, biceps femoris and semitendinosus to de lower experimental limb. A single session of 10 minutes will be applied.

Participants will be used as their own controls, with one lower extremity randomly receiving intervention. The control extremity will not receive any intervention

Outcomes

Primary Outcome Measures

Hamstring neuromuscular activity
Hamstring neuromuscular activity (% of muscular fiber recruitment) will be assessed by surface electromyogram (mDurance). The electrodes will be placed on hamstring muscle while performing a functional movement.
Gluteus maximus neuromuscular activity
Gluteus maximus neuromuscular activity (% of muscular fiber recruitment) will be assessed by surface electromyogram (mDurance). The electrodes will be placed on gluteus maximus muscle while performing a functional movement.
Hamstring isometric strength
Isometric muscle strength (Kg) will be evaluated by means of a digital dynamometer (Microfeet 2). This measures will be taken across a knee flexion.
Guteus maximus isometric strength
Isometric muscle strength (Kg) will be evaluated by means of a digital dynamometer (Microfeet 2). This measures will be measured by means of hip extension.
Height on counter movement jump
Height (centimeters) on counter movement jump will be assessed using a mobile application called "My jump". Its data has been used as an indirect indicator of explosive muscular strength of lower limb
Time flight on counter movement jump
Time flight (milliseconds) on counter movement jump will be assessed using a mobile application called "My jump".
Force on counter movement jump
Force (newtons) on counter movement jump will be assessed using a mobile application called "My jump".
Back chain flexibility Changes
Back chain flexibility is going to be assessed by means of modified Back Saver Sit and reach test (centimeters).
Hamstring flexibility changes
Hamstring muscles flexibility will be assessed using the passive knee extension test (degrees) by means of goniometer.

Secondary Outcome Measures

Full Information

First Posted
March 28, 2021
Last Updated
March 31, 2021
Sponsor
Universitat Internacional de Catalunya
search

1. Study Identification

Unique Protocol Identification Number
NCT04827082
Brief Title
Effects of Diacutaneous Fibrolysis on Flexibility and Active Neuromuscular Response
Official Title
Effects of Diacutaneous Fibrolysis on Flexibility and Active Neuromuscular Response on Posterior Muscular Chain of Lower Limb in Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (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
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. 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. The aim of this study is to evaluate the immediate, and after 30 minutes, effects of a single diacutaneous fibrolysis session on flexibility, strength and neuromuscular activity on hamstring in athletes. A randomized controlled trial with blind evaluator. Randomization will be done 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. Each outcome assessment will be performed by a blinded evaluator at the baseline, immediately after the technique application and 30 minutes after.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hamstring Contractures
Keywords
Diacutaneous fibrolysis, Physiotherapy, Neuromuscular response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized control trial
Masking
Outcomes Assessor
Masking Description
The assessor will not know if patient have received the treatment or not
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diacutaneous fibrolysis group
Arm Type
Experimental
Arm 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. Regardless of its own dominance, diacutaneous fibrolysis will be applied to de following muscles and intermuscular septums: gluteus maximus, biceps femoris and semitendinosus to de lower experimental limb. A single session of 10 minutes will be applied.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants will be used as their own controls, with one lower extremity randomly receiving intervention. The control extremity will not receive any intervention
Intervention Type
Other
Intervention Name(s)
Diacutaneous fibrolysis
Intervention 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. Regardless of its own dominance, diacutaneous fibrolysis will be applied to de following muscles and intermuscular septums: gluteus maximus, biceps femoris and semitendinosus to de lower experimental limb. A single session of 10 minutes will be applied.
Primary Outcome Measure Information:
Title
Hamstring neuromuscular activity
Description
Hamstring neuromuscular activity (% of muscular fiber recruitment) will be assessed by surface electromyogram (mDurance). The electrodes will be placed on hamstring muscle while performing a functional movement.
Time Frame
Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]
Title
Gluteus maximus neuromuscular activity
Description
Gluteus maximus neuromuscular activity (% of muscular fiber recruitment) will be assessed by surface electromyogram (mDurance). The electrodes will be placed on gluteus maximus muscle while performing a functional movement.
Time Frame
Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]
Title
Hamstring isometric strength
Description
Isometric muscle strength (Kg) will be evaluated by means of a digital dynamometer (Microfeet 2). This measures will be taken across a knee flexion.
Time Frame
Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]
Title
Guteus maximus isometric strength
Description
Isometric muscle strength (Kg) will be evaluated by means of a digital dynamometer (Microfeet 2). This measures will be measured by means of hip extension.
Time Frame
Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]
Title
Height on counter movement jump
Description
Height (centimeters) on counter movement jump will be assessed using a mobile application called "My jump". Its data has been used as an indirect indicator of explosive muscular strength of lower limb
Time Frame
Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]
Title
Time flight on counter movement jump
Description
Time flight (milliseconds) on counter movement jump will be assessed using a mobile application called "My jump".
Time Frame
Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]
Title
Force on counter movement jump
Description
Force (newtons) on counter movement jump will be assessed using a mobile application called "My jump".
Time Frame
Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]
Title
Back chain flexibility Changes
Description
Back chain flexibility is going to be assessed by means of modified Back Saver Sit and reach test (centimeters).
Time Frame
Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]
Title
Hamstring flexibility changes
Description
Hamstring muscles flexibility will be assessed using the passive knee extension test (degrees) by means of goniometer.
Time Frame
Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Athletes <160º in the Passive Knee Extension test Participants must sign and have informed consent. Exclusion Criteria: Poor skin Trophic condition Taking anticoagulants Inflammatory process Recent musculoskeletal lower limb injury (< 6 month)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aida C Arróniz, MsC
Phone
635246977
Email
acadellans@uic.es
Facility Information:
Facility Name
Universitat Internacional de Catalunya
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aida Ms Cadellans-Arróniz, MsC
Phone
+34635246977
Email
acadellans@uic.es

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effects of Diacutaneous Fibrolysis on Flexibility and Active Neuromuscular Response

We'll reach out to this number within 24 hrs