Self Myofascial ReleaseNCT04808024
Myofascial Release and Muscle Activity
A study testing SelfMyofascial Release in people with Self Myofascial Release and Muscle Tone Abnormalities, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The aim of the study is to assess the impact of SMR intervention in the hamstring muscles on the activity of the biceps and gluteus muscles. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Self Myofascial Release, Muscle Tone Abnormalities
- What is being tested?
- SelfMyofascial Release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 4 Jan 2021to May 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- signing informed consent to participate in the study
- age in the range of 18-40 years
Who cannot join
- people who had orthopedic injuries to the lower limbs and the lumbar-pelvic-iliac complex in the last year
- people who reported pain in the lower limbs and the lumbar-pelvic-iliac complex on the day of the examination
- people who underwent myofascial therapy in the last 6 weeks
- people with non-specific neuromuscular disorders
Trial locations and contacts
1 site in 1 country.
Tomasz Król contact
Poland1 site, 1 recruiting
- Recruiting
Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland
Katowice, Silesian Voivodeship, 40-752
Magdalena Dąbrowska-Galas, Phd, 515321323 ext. 048, magdalena.j.dabrowska@gmail.com
About this study
Official title: Self Myofascial Release (SMR) and Bioelectrical Activity of Muscles
The aim of the study is to assess the impact of SMR intervention in the hamstring muscles on the activity of the biceps and gluteus muscles.
Read the detailed description
The study will cover 40 men, players of amateur football leagues, aged 18 - 40. The test will include the measurement of sEMG of the biceps and gluteal muscles during the exercise, followed by myofascial self-release (SMR). Muscle sEMG was re-measured immediately after roller therapy.
- Conditions
- Self Myofascial Release, Muscle Tone Abnormalities
- Being tested
- SelfMyofascial Release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelfMyofascial ReleaseProcedure or surgery
Myofascial auto-release consisted of rolling the roller on a group of knee flexors for 3.5 minutes between the sciatic tumor and the knee joint in both directions, omitting the popliteal fossa. Before and after the intervention, sEMG of the biceps and gluteal muscles will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Players of amateur football leagues | Experimental | The players of amateur football leagues who will receive SelfMyofascial Release intervention Receives: Procedure: SelfMyofascial Release |
| Control group | No intervention | The players of amateur football leagues who will receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Surface electromyography (sEMG) examination before SMR
The sEMG examination of the biceps and gluteus muscles will be performed using the MyoTrace 400 recorder by Noraxon USA Inc. with a sampling frequency of 1000 Hz, using the bipolar method, in accordance with SENIAM standards.The bioelectrical activity of the muscles will be tested during the squat.
Measured: Before the SMR intervention
Surface electromyography (sEMG) examination immediately after SMR
The change in bioelectrical activity of the biceps and gluteus muscles will be performed. The bioelectrical activity of the muscles will be tested during the squat.
Measured: Immediately after the SMR intervention
Surface electromyography (sEMG) examination 5 minutes after SMR
The change in bioelectrical activity of the biceps and gluteus muscles will be performed. The bioelectrical activity of the muscles will be tested during the squat.
Measured: 5 minutes after the SMR intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start4 Jan 2021
- Primary completion21 Apr 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self Myofascial ReleaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Michalik, Medical University of Silesia
- Investigators
- Magdalena Dąbrowska-Galas, Study director, Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia in Katowice, Katowice, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808024
- Sponsor's protocol ID
- SMR and muscle
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and / or analyzed in the present study will be available from the respective author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Myofascial Release (SMR) and Bioelectrical Activity of Muscles
- ClinicalTrials.gov ID
- NCT04808024
- Acronym / sponsor ID
- SMR and muscle
- Conditions
- Self Myofascial Release, Muscle Tone Abnormalities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 21 Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 19 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.
The aim of the study is to assess the impact of SMR intervention in the hamstring muscles on the activity of the biceps and gluteus muscles.
Detailed description
The study will cover 40 men, players of amateur football leagues, aged 18 - 40. The test will include the measurement of sEMG of the biceps and gluteal muscles during the exercise, followed by myofascial self-release (SMR). Muscle sEMG was re-measured immediately after roller therapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Players of amateur football leagues | Experimental | Procedure: SelfMyofascial ReleaseThe players of amateur football leagues who will receive SelfMyofascial Release intervention |
| Control group | No intervention | –The players of amateur football leagues who will receive no intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- signing informed consent to participate in the study
- age in the range of 18-40 years
Key exclusion criteria (4 listed)
- people who had orthopedic injuries to the lower limbs and the lumbar-pelvic-iliac complex in the last year
- people who reported pain in the lower limbs and the lumbar-pelvic-iliac complex on the day of the examination
- people who underwent myofascial therapy in the last 6 weeks
- people with non-specific neuromuscular disorders
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 |
|---|---|---|
| SelfMyofascial ReleaseMyofascial auto-release consisted of rolling the roller on a group of knee flexors for 3.5 minutes between the sciatic tumor and the knee joint in both directions, omitting the popliteal fossa. Before and after the intervention, sEMG of the biceps and gluteal muscles will be performed. | Procedure or surgery | Players of amateur football leagues |
Primary outcome
1. Surface electromyography (sEMG) examination before SMR
Time frame: Before the SMR intervention
The sEMG examination of the biceps and gluteus muscles will be performed using the MyoTrace 400 recorder by Noraxon USA Inc. with a sampling frequency of 1000 Hz, using the bipolar method, in accordance with SENIAM standards.The bioelectrical activity of the muscles will be tested during the squat.
Surface electromyography (sEMG) examination immediately after SMR
Time frame: Immediately after the SMR intervention
The change in bioelectrical activity of the biceps and gluteus muscles will be performed. The bioelectrical activity of the muscles will be tested during the squat.
Surface electromyography (sEMG) examination 5 minutes after SMR
Time frame: 5 minutes after the SMR intervention
The change in bioelectrical activity of the biceps and gluteus muscles will be performed. The bioelectrical activity of the muscles will be tested during the squat.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: No. The datasets used and / or analyzed in the present study will be available from the respective author upon reasonable request.
Related trials for Self Myofascial Release
Recruiting
Effectiveness of Tele-Rehabilitation in Managing Rhomboid Trigger Points in Patients With Myofascial Pain Syndrome
Myofascial Pain Syndrome
Not yet recruiting
Effects of Thoracolumbar Fascia Myofascial Release in Chronic Low Back Pain
Chronic Non-specific Low Back Pain
Recruiting
Self-Myofascial Release Plus Exercise Versus Exercise Alone in Type 2 Diabetes
Type 2 Diabetes
Recruiting
THE MYOFASCIAL SYSTEM AND MINIMIZING THE RISK OS INJURY IN SPORT
Sports Injuries, Flexibility
Enrolling by invitation
The Effects of Self-Myofascial Release on Physical Fitness and Swing Performance in Male Collegiate Golfers in China
Range of Motion, Articular, Physical Fitness
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.
Tomasz Król contact
Magdalena Dąbrowska-Galas study director
Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia in Katowice, Katowice, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SelfMyofascial Release in people with Self Myofascial Release and Muscle Tone Abnormalities, run by Medical University of Silesia at 1 site in Poland.
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 2 inclusion and 4 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 19 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 Poland. 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 Piotr Michalik (694979743, piotrmichalikk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Surface electromyography (sEMG) examination before SMR (time frame: Before the SMR intervention). The study lists 3 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 19 Mar 2021.