NCT04778293

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. 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.

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 Feb 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2021

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

February 22, 2021

Last Update Submit

February 26, 2021

Conditions

Hamstring Contractures

Outcome Measures

Primary Outcomes (7)

  • Contraction time changes

    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

    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

    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

    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

    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

    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

    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.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Other: Diacutaneous fibrolysis

Control Group

NO INTERVENTION

No intervention

Interventions

Diacutaneous fibrolysisOTHER

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

Experimental Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Will involve any contraindication related to diacutaneous fibrolysis such us poor skin or trophic condition, taking anticoagulants, inflammatory process or recent injury).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

Related Publications (1)

  • Cadellans-Arroniz A, Lopez-de-Celis C, Perez-Bellmunt A, Rodriguez-Sanz J, Llurda-Almuzara L, Gonzalez-Rueda V, Rodriguez-Rubio PR. Effects of Diacutaneous Fibrolysis on Passive Neuromuscular Response and Mechanosensitivity in Athletes with Hamstring Shortening: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jun 18;18(12):6554. doi: 10.3390/ijerph18126554.

    PMID: 34207080DERIVED

Central Study Contacts

Aida C Cadellans-Arróniz, MsC

CONTACT

635246977acadellans@uic.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessment will be performed by a blinded evaluator at the baseline, immediately after the technique application and 30 minutes after.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2021

First Posted

March 3, 2021

Study Start

February 22, 2021

Primary Completion

July 10, 2021

Study Completion

September 27, 2021

Last Updated

March 3, 2021

Record last verified: 2021-02

Locations

ES(1)