NCT04827082

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

1 month

First QC Date

March 28, 2021

Last Update Submit

March 31, 2021

Conditions

Keywords

Diacutaneous fibrolysisPhysiotherapyNeuromuscular response

Outcome Measures

Primary Outcomes (9)

  • 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.

    Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]

  • 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.

    Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]

  • 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.

    Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]

  • 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.

    Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]

  • 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

    Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]

  • Time flight on counter movement jump

    Time flight (milliseconds) on counter movement jump will be assessed using a mobile application called "My jump".

    Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]

  • Force on counter movement jump

    Force (newtons) on counter movement jump will be assessed using a mobile application called "My jump".

    Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]

  • Back chain flexibility Changes

    Back chain flexibility is going to be assessed by means of modified Back Saver Sit and reach test (centimeters).

    Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]

  • Hamstring flexibility changes

    Hamstring muscles flexibility will be assessed using the passive knee extension test (degrees) by means of goniometer.

    Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]

Study Arms (2)

Diacutaneous fibrolysis group

EXPERIMENTAL

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.

Other: Diacutaneous fibrolysis

Control group

NO INTERVENTION

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

Interventions

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.

Diacutaneous fibrolysis group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

Central Study Contacts

Aida C Arróniz, MsC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor will not know if patient have received the treatment or not
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 28, 2021

First Posted

April 1, 2021

Study Start

April 1, 2021

Primary Completion

May 1, 2021

Study Completion

July 1, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations