Hamstring ContracturesNCT04778293
Effects of Diacutaneous Fibrolysis on Passive 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 40 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
- 22 Feb 2021to 27 Sep 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Will involve any contraindication related to diacutaneous fibrolysis such us poor skin or trophic condition, taking anticoagulants, inflammatory process or recent injury).
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 C Cadellans-Arróniz, MsC, 635246977, acadellans@uic.es
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Hamstring Contractures
- Being tested
- Diacutaneous fibrolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Diacutaneous fibrolysis |
| Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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 .
Measured: 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
Measured: at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start22 Feb 2021 (estimated)
- Primary completion10 Jul 2021 (estimated)
- Study completion27 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 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
- NCT04778293
- Sponsor's protocol ID
- FIS-2020-04
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34207080
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diacutaneous Fibrolysis on Passive Neuromuscular Response and Mechanosensitivity on Posterior Muscular Chain of Lower Limb in Athletes.
- ClinicalTrials.gov ID
- NCT04778293
- Acronym / sponsor ID
- FIS-2020-04
- Conditions
- Hamstring Contractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 22 Feb 2021 (estimated)
- Primary completion
- 10 Jul 2021 (estimated)
- Study completion
- 27 Sep 2021 (estimated)
- First posted
- 3 Mar 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. 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Diacutaneous fibrolysisAn 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 |
| Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Will involve any contraindication related to diacutaneous fibrolysis such us poor skin or trophic condition, taking anticoagulants, inflammatory process or recent injury).
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 fibrolysisAn 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 | Other | Experimental Group |
Primary outcome
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.
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.
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.
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.
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
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 .
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 34207080Cadellans-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.
- 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 1 inclusion and 1 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 3 Mar 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 Cadellans-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?
Contraction time changes (time frame: at baseline, after diacutaneous fibrolysis intervention and 30 minutes later.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04778293, which also lists 1 linked publication.
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 3 Mar 2021.