Muscle, Ligament and Fascia DisordersNCT04689698
The Effect of Flossing to Joint Range of Motion.
A study testing Thomayer test in people with Muscle, Ligament and Fascia Disorders, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
This research aims to verify the effect of therapy called "tissue flossing" on the range of motion and examine the impact of this treatment on the Superficial fascial backline, described by Myers. Read more about this study
- Who is it for?
- Ages 19 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle, Ligament and Fascia Disorders
- What is being tested?
- Thomayer test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Dec 2020to 30 Apr 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 19 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No previous experience with the tissue flossing method
- Each proband had to do recreational or elite sports
Who cannot join
- persons with an acute, especially infectious disease, person with an injury or persons in the process of recovery after an injury or illness
- vascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Flossing Tape Therapy on the Range of Motion and Influencing of Fascial Chains in the Lower Limbs
This research aims to verify the effect of therapy called "tissue flossing" on the range of motion and examine the impact of this treatment on the Superficial fascial backline, described by Myers. The research aims to verify whether the thick rubber bands used to create a certain degree of compression in a predetermined part of the musculoskeletal system can help to increase the range of motion (ROM) and whether this increase in motion can be achieved by influencing fascial chains even in distant parts of the musculoskeletal system, outside the primary therapeutic zone treated by the tissue flossing method. The research aims to verify and especially compare the patient's joints' range of motion before and immediately after the tissue flossing treatment. The results of the experiment clarify the influence of the tissue flossing therapy method on the range of motion at the application site, on the range of motion in other joints within the Superficial fascial backline described by Myers and last but not least to prove the existence of these fascial chains in the human body.
Read the detailed description
Methodology:
The weight-bearing lunge test (WBLT) was used to evaluate the change in the ankle joint's range of motion. A simple forward bend test - the Thomayer test - was used to evaluate the therapy's effect on the Superficial fascial backline described by Myers. Both tests are non-invasive. Both tests can be used to evaluate the outcome of a given therapy objectively. Both tests are elementary to perform and highly standardized and commonly used in similar research.
After completing the entrance tests, the tissue flossing method is applied to each proband. The treatment alone does not typically last more than 20 minutes for any proband. As part of the tissue flossing treatment, both lower limbs of the proband will be treated. The "tissue flossing" method will be applied according to the authors' standard recommendations first to the plantar fascia area, then to the ankle joint. Finally, the last treated structure will be the area of fascia cruris. The duration of each application does not exceed 2 minutes. The order of individual applications is determined in advance as follows: right and then left plantar fascia, right and then left ankle joint and right and then left fascia cruris. Each application will be supplemented by the standard manual treatment or supplemented by the proband's active movement. After a total of 6 treatments, the therapeutic unit will be finished, and each proband will be re-examined using the same tests as before the treatment. If a given proband experiences any undesirable complications during the application of the "tissue flossing" method or applying the given method to the proband is subjectively unpleasant, the given treatment will be finished immediately.
- Conditions
- Muscle, Ligament and Fascia Disorders
- Being tested
- Thomayer test
- Keywords
- Muscle chains, fascia, range of motion, viscosity.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thomayer testDiagnostic test
Also called Dorziflexion of an ankle
Testing of the ankle in sagittal line and Thomayer test before and after flossing of sole.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Diagnostic Test: Thomayer test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of range of motion of ankle in sagital line
Measurement without flossing of sole in natura
Measured: 5 minutes
Measurement of range of motion of ankle in sagital line
Flossing of sole and than measurement after flossing of sole
Measured: 15 minutes
Measurement of range of motion of lumbar spine in sagital line
Measurement before flossing of sole
Measured: 5 minutes
Measurement of range of motion of lumbar spine in sagital line
Measurement after flossing of sole
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Dec 2020
- Primary completion30 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle, Ligament and Fascia DisordersStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malá Jitka, Charles University, Czech Republic
- Investigators
- Jitka Malá, PhDr.Ph.D., Principal investigator, Charles University, Faculty of physical education and sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689698
- Sponsor's protocol ID
- Pisarčík, Flossing
- Status last verified
- Dec 2020
- First submitted
- 23 Dec 2020
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Flossing Tape Therapy on the Range of Motion and Influencing of Fascial Chains in the Lower Limbs
- ClinicalTrials.gov ID
- NCT04689698
- Acronym / sponsor ID
- Pisarčík, Flossing
- Conditions
- Muscle, Ligament and Fascia Disorders
- Keywords
- Muscle chains, fascia, range of motion, viscosity.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 30 Dec 2020 (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.
This research aims to verify the effect of therapy called "tissue flossing" on the range of motion and examine the impact of this treatment on the Superficial fascial backline, described by Myers. The research aims to verify whether the thick rubber bands used to create a certain degree of compression in a predetermined part of the musculoskeletal system can help to increase the range of motion (ROM) and whether this increase in motion can be achieved by influencing fascial chains even in distant parts of the musculoskeletal system, outside the primary therapeutic zone treated by the tissue flossing method. The research aims to verify and especially compare the patient's joints' range of motion before and immediately after the tissue flossing treatment. The results of the experiment clarify the influence of the tissue flossing therapy method on the range of motion at the application site, on the range of motion in other joints within the Superficial fascial backline described by Myers and last but not least to prove the existence of these fascial chains in the human body.
Detailed description
Methodology:
The weight-bearing lunge test (WBLT) was used to evaluate the change in the ankle joint's range of motion. A simple forward bend test - the Thomayer test - was used to evaluate the therapy's effect on the Superficial fascial backline described by Myers. Both tests are non-invasive. Both tests can be used to evaluate the outcome of a given therapy objectively. Both tests are elementary to perform and highly standardized and commonly used in similar research.
After completing the entrance tests, the tissue flossing method is applied to each proband. The treatment alone does not typically last more than 20 minutes for any proband. As part of the tissue flossing treatment, both lower limbs of the proband will be treated. The "tissue flossing" method will be applied according to the authors' standard recommendations first to the plantar fascia area, then to the ankle joint. Finally, the last treated structure will be the area of fascia cruris. The duration of each application does not exceed 2 minutes. The order of individual applications is determined in advance as follows: right and then left plantar fascia, right and then left ankle joint and right and then left fascia cruris. Each application will be supplemented by the standard manual treatment or supplemented by the proband's active movement. After a total of 6 treatments, the therapeutic unit will be finished, and each proband will be re-examined using the same tests as before the treatment. If a given proband experiences any undesirable complications during the application of the "tissue flossing" method or applying the given method to the proband is subjectively unpleasant, the given treatment will be finished immediately.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Diagnostic Test: Thomayer test |
Who may qualify
- Ages
- 19 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- No previous experience with the tissue flossing method
- Each proband had to do recreational or elite sports
Key exclusion criteria (2 listed)
- persons with an acute, especially infectious disease, person with an injury or persons in the process of recovery after an injury or illness
- vascular diseases
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 |
|---|---|---|
| Thomayer testAlso: Dorziflexion of an ankleTesting of the ankle in sagittal line and Thomayer test before and after flossing of sole. | Diagnostic test | experimental group |
Primary outcome
Measurement of range of motion of ankle in sagital line
Time frame: 5 minutes
Measurement without flossing of sole in natura
Measurement of range of motion of ankle in sagital line
Time frame: 15 minutes
Flossing of sole and than measurement after flossing of sole
Measurement of range of motion of lumbar spine in sagital line
Time frame: 5 minutes
Measurement before flossing of sole
Measurement of range of motion of lumbar spine in sagital line
Time frame: 15 minutes
Measurement after flossing of sole
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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.
Jitka Malá, PhDr.Ph.D. principal investigator
Charles University, Faculty of physical education and sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thomayer test in people with Muscle, Ligament and Fascia Disorders, run by Charles University, Czech Republic at 1 site in Czechia.
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 2 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: finished, as of the sponsor's last update on 2 Mar 2023. 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of range of motion of ankle in sagital line (time frame: 5 minutes). The study lists 4 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 2 Mar 2023.