Hamstring ContracturesNCT04827082
Effects of Diacutaneous Fibrolysis on Flexibility and Active Neuromuscular Response
A study testing Diacutaneous fibrolysis in people with Hamstring Contractures, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hamstring Contractures
- What is being tested?
- Diacutaneous fibrolysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2021to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Athletes
- <160º in the Passive Knee Extension test
- Participants must sign and have informed consent.
Who cannot join
- Poor skin
- Trophic condition
- Taking anticoagulants
- Inflammatory process
- Recent musculoskeletal lower limb injury (< 6 month)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Aida Ms Cadellans-Arróniz, MsC, +34635246977, acadellans@uic.es
About this study
Official title: Effects of Diacutaneous Fibrolysis on Flexibility and Active Neuromuscular Response 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. 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.
- Conditions
- Hamstring Contractures
- Being tested
- Diacutaneous fibrolysis
- Keywords
- Diacutaneous fibrolysis, Physiotherapy, Neuromuscular response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diacutaneous fibrolysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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".
Measured: 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".
Measured: 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).
Measured: 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.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention); Change between baseline (immediately before intervention) and 30 minutes after intervention]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hamstring ContracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Cadellans Arróniz, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827082
- Sponsor's protocol ID
- FIS202004
- Status last verified
- Mar 2021
- First submitted
- 28 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diacutaneous Fibrolysis on Flexibility and Active Neuromuscular Response on Posterior Muscular Chain of Lower Limb in Athletes
- ClinicalTrials.gov ID
- NCT04827082
- Acronym / sponsor ID
- FIS202004
- Conditions
- Hamstring Contractures
- Keywords
- Diacutaneous fibrolysis, Physiotherapy, Neuromuscular response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Diacutaneous fibrolysis group | Experimental | Other: Diacutaneous fibrolysisDiacutaneous 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. |
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Athletes
- <160º in the Passive Knee Extension test
- Participants must sign and have informed consent.
Key exclusion criteria (5 listed)
- Poor skin
- Trophic condition
- Taking anticoagulants
- Inflammatory process
- Recent musculoskeletal lower limb injury (< 6 month)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diacutaneous fibrolysisDiacutaneous 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 group |
Primary outcome
Hamstring neuromuscular activity
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]
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
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]
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
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]
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
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]
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
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]
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 frame: 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 (milliseconds) on counter movement jump will be assessed using a mobile application called "My jump".
Force on counter movement 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]
Force (newtons) on counter movement jump will be assessed using a mobile application called "My jump".
Back chain flexibility Changes
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]
Back chain flexibility is going to be assessed by means of modified Back Saver Sit and reach test (centimeters).
Hamstring flexibility changes
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]
Hamstring muscles flexibility will be assessed using the passive knee extension test (degrees) by means of goniometer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diacutaneous fibrolysis in people with Hamstring Contractures, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aida C Arróniz, MsC (635246977, acadellans@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamstring neuromuscular activity (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]). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.