Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04778293
Other study ID # FIS-2020-04
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 22, 2021
Est. completion date September 27, 2021

Study information

Verified date February 2021
Source Universitat Internacional de Catalunya
Contact Aida C Cadellans-Arróniz, MsC
Phone 635246977
Email acadellans@uic.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date September 27, 2021
Est. primary completion date July 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Participants must sign and have informed consent. They must have shortening of the hamstring muscles (being considered itself as such <160ยบ in the Passive Knee Extension test as a main inclusion criteria. Exclusion Criteria: - Will involve any contraindication related to diacutaneous fibrolysis such us poor skin or trophic condition, taking anticoagulants, inflammatory process or recent injury).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Diacutaneous fibrolysis
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

Locations

Country Name City State
Spain Universitat Internacional de Catalunya Sant Cugat Del Vallès Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05008731 - Effect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction Phase 3
Completed NCT04334772 - Percutaneous Microelectrolysis in Agility, Joint Range and Strength N/A
Recruiting NCT05931120 - Comparison of Dry Needling and IASTM on Hamstring Tightness in Posterior Pelvic Tilt N/A
Completed NCT05866913 - Neurodynamics vs. Stretching in Soccer Players With Short Hamstring Syndrome N/A
Completed NCT03589573 - Effect of Muscle Strength on Hamstring Flexibility in Children With Duchenne Muscular Dystrophy
Completed NCT03178604 - Classic and Sham Massage on Psychological and Physical Functional Variables in Athletes N/A
Completed NCT03637439 - Neuromodulation in Patients With Hamstring Shortening N/A
Completed NCT04716205 - Mulligan's Bent Leg Raise Technique in Healthy Females N/A
Completed NCT04668092 - Functional DN for Shortened HS Muscle N/A
Completed NCT04193683 - The Effect Of Myofascial Release Technique On Respiratory Parameters in Subjects With Short Hamstring Muscle N/A
Completed NCT04784741 - Effect of Low Amplitude Vibration Therapy on Flexibility of Hamstring Muscle in Athletes of Pakistan N/A
Recruiting NCT05793242 - Immediate and 24-hour Effects of HyperVolt, Body Tempering, and Cupping Compared to Stretching on Hamstring Flexibility N/A
Recruiting NCT04827082 - Effects of Diacutaneous Fibrolysis on Flexibility and Active Neuromuscular Response N/A