Flexibility, WaxyNCT03864159
Suction Cups and Foam Roller in the Improvement of the Flexibility in Basketball Players
A study testing Suction cups and Foam roller in people with Flexibility, Waxy, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction. Basketball is a predominantly anaerobic exercise that exposes to high intensity actions (jumps, speed control, accelerations and decelerations, and changes of direction). A lack of flexibility can affect the appearance of muscle injuries. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Flexibility, Waxy
- What is being tested?
- Suction cups and Foam roller
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2019to 20 Jun 2019
- 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 to 25 years
- Amateur basketball players
- Belong to the Celeste club
- Not having any injury to the hamstring musculature at the time of the study
Who cannot join
- At the time of the study they are included in a program of individualized strength training in lower limbs
- Subjects with alterations in venous return or congenital coagulopathies
- Subjects who present hypermobility
- Not signed the informed consent document
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Intervention Using the Suction Cups and the Foam Roller in the Improvement of the Flexibility of the Ischiotibial Musculature in Basketball Players From 18 to 25 Years Old. A Randomized Clinical Study
Introduction. Basketball is a predominantly anaerobic exercise that exposes to high intensity actions (jumps, speed control, accelerations and decelerations, and changes of direction). A lack of flexibility can affect the appearance of muscle injuries. Foam roller is a myofascial self-release technique using a foam roller. The suction cups are an instrumental technique where the negative pressure produces an increase in the blood flow of the tissues.
Goals. To evaluate the effectiveness of a physiotherapy intervention through suction cups and foam roller in amateur basketball players.
Read more
Study design. Randomized, single-blind clinical study with a follow-up period. Methodology. The 20 basketball players that are expected to be recruited will be randomly assigned to the two study groups: experimental (suction cups and Foam roller) and control (Foam roller). The intervention will last 4 weeks, with 2 weekly sessions. The study variable will be: hamstring flexibility (measured with finger-ground, Well and Shober tests). The analysis of normality will be carried out with the Shapiro-Wilk test. In case of homogeneity of the groups, we will use parametric tests: t-student test of repeated measures (difference between evaluations) and ANOVA of repeated means (intra and intersubject effect).
Expected results. An intervention using suction cups and foam roller is effective in improving the flexibility of the hamstring muscles in basketball players.
- Conditions
- Flexibility, Waxy
- Being tested
- Suction cups, Foam roller
- Keywords
- Cupping therapy, Foam roller, Basketball, Flexibility, Hamstring
- Medical subject headings
- Catalepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction cupsOther
Also called Hamstring flexibility
The technique will be performed with the subject sitting on the floor, placing the Foam roller on the back of the thigh, requesting the athlete to perform cranial and caudal movements during the established time. The stretching exercise with the Foam roller will be done during 2 minutes in each member. The intervention through the suction cups will be performed with the subject in prone position, on the stretcher. The suckers are placed in the proximal part where the posterior musculature of the leg originates and in the distal part of the biceps femoris, semitendinosus and semimembranous insertion. This administration of the suckers will be applied during a period of 7 minutes in each member.
Foam rollerOther
Also called Hamstring flexibility
Each session will last 18 minutes, taking place two days a week, in a period of 4 weeks. The intervention will be carried out before starting the training session. The intervention through the self-administration of Foam roller has the objective of increasing the flexibility of the isquitibial musculature. The technique will be performed with the subject sitting on the floor, placing the Foam roller on the back of the thigh, requesting the athlete to perform cranial and caudal movements during the established time. The stretching exercise with the Foam roller will be done during 2 minutes in each member.
| Study group | Role | What they receive |
|---|---|---|
| Suction cups | Experimental | The technique will be performed with the subject sitting on the floor, placing the Foam roller on the back of the thigh, requesting the athlete to perform cranial and caudal movements during the established time.The intervention through the suction cups will consist of its application and produce increased flexibility of the hamstring musculature. The technique will be performed with the subject in prone position, on the stretcher, while the physiotherapist will be placed next to the member to be treated. The suckers are placed in the proximal part where the posterior musculature of the leg originates and in the distal part of the biceps femoris, semitendinosus and semimembranous insertion. This administration of the suckers will be applied during a period of 7 minutes in each member. Receives: Other: Suction cups |
| Foam roller | Active comparator | The intervention will be carried out before starting the training session. The technique will be performed with the subject sitting on the floor, placing the Foam roller on the back of the thigh, requesting the athlete to perform cranial and caudal movements during the established time. The stretching exercise with the Foam roller will be done during 2 minutes in each member. Receives: Other: Foam roller |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline elongation capacity of the hamstring musculature after treatment and at month
The assessment of the elongation capacity of the hamstring musculature will be carried out by applying the Wells drawer or test. The subject will sit on the floor in front of the drawer, with the feet together and the plants resting on the front of the drawer, and the knees extended. Next, the athlete must tilt the trunk forward and extend the arms, sliding with outstretched hands until reaching the maximum stretch that allows its trunk flexion. The result that will be recorded corresponds to the point you can touch with your fingers. The unit of measurement for this test is the centimeter (the longer the length, the greater the hamstring elongation capacity).
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (2)
Change from baseline ischithiobial extensibility after treatment and at month
The assessment of the ischithiobial extensibility will be made by applying the finger-floor test. The subject will have to reach the greatest possible distance from the standing position with the knees in extension, by bringing the hands (by flexing the spine) towards the ground. The evaluator will measure the distance between the tip of the third finger and the floor, with the unit of measure being the centimeter (a longer length will indicate greater hamstring extensibility).
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline flexibility after treatment and at month
The assessment of flexibility will be measured using the Schober test. The physiotherapist will stand behind the athlete, while the subject is standing with legs extended. The evaluator will mark a line that will connect both posterior superior iliac spines, at the level of the spinous process of the fifth lumbar vertebra. Later a second mark will be made 10 centimeters away in the cranial direction to the first. Next, the subject will be asked to perform maximum flexion of the spine keeping the knees extended. When the subject is in that position of maximum column flexion, a measurement of the distance between the two marks will be made, comparing this result with the initial distance of 10 centimeters. The centimeter is the unit of measurement and a higher score indicates greater muscle flexibility.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start10 Mar 2019
- Primary completion20 Apr 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexibility, WaxyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864159
- Sponsor's protocol ID
- FLEX
- Status last verified
- Jan 2020
- First submitted
- 4 Mar 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Intervention Using the Suction Cups and the Foam Roller in the Improvement of the Flexibility of the Ischiotibial Musculature in Basketball Players From 18 to 25 Years Old. A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03864159
- Acronym / sponsor ID
- FLEX
- Conditions
- Flexibility, Waxy
- Keywords
- Cupping therapy, Foam roller, Basketball, Flexibility, Hamstring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 6 Mar 2019 (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.
Introduction. Basketball is a predominantly anaerobic exercise that exposes to high intensity actions (jumps, speed control, accelerations and decelerations, and changes of direction). A lack of flexibility can affect the appearance of muscle injuries. Foam roller is a myofascial self-release technique using a foam roller. The suction cups are an instrumental technique where the negative pressure produces an increase in the blood flow of the tissues.
Goals. To evaluate the effectiveness of a physiotherapy intervention through suction cups and foam roller in amateur basketball players.
Study design. Randomized, single-blind clinical study with a follow-up period. Methodology. The 20 basketball players that are expected to be recruited will be randomly assigned to the two study groups: experimental (suction cups and Foam roller) and control (Foam roller). The intervention will last 4 weeks, with 2 weekly sessions. The study variable will be: hamstring flexibility (measured with finger-ground, Well and Shober tests). The analysis of normality will be carried out with the Shapiro-Wilk test. In case of homogeneity of the groups, we will use parametric tests: t-student test of repeated measures (difference between evaluations) and ANOVA of repeated means (intra and intersubject effect).
Expected results. An intervention using suction cups and foam roller is effective in improving the flexibility of the hamstring muscles in basketball players.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suction cups | Experimental | Other: Suction cupsThe technique will be performed with the subject sitting on the floor, placing the Foam roller on the back of the thigh, requesting the athlete to perform cranial and caudal movements during the established time.The intervention through the suction cups will consist of its application and produce increased flexibility of the hamstring musculature. The technique will be performed with the subject in prone position, on the stretcher, while the physiotherapist will be placed next to the member to be treated. The suckers are placed in the proximal part where the posterior musculature of the leg originates and in the distal part of the biceps femoris, semitendinosus and semimembranous insertion. This administration of the suckers will be applied during a period of 7 minutes in each member. |
| Foam roller | Active comparator | Other: Foam rollerThe intervention will be carried out before starting the training session. The technique will be performed with the subject sitting on the floor, placing the Foam roller on the back of the thigh, requesting the athlete to perform cranial and caudal movements during the established time. The stretching exercise with the Foam roller will be done during 2 minutes in each member. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 to 25 years
- Amateur basketball players
- Belong to the Celeste club
- Not having any injury to the hamstring musculature at the time of the study
Key exclusion criteria (4 listed)
- At the time of the study they are included in a program of individualized strength training in lower limbs
- Subjects with alterations in venous return or congenital coagulopathies
- Subjects who present hypermobility
- Not signed the informed consent document
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 |
|---|---|---|
| Suction cupsAlso: Hamstring flexibilityThe technique will be performed with the subject sitting on the floor, placing the Foam roller on the back of the thigh, requesting the athlete to perform cranial and caudal movements during the established time. The stretching exercise with the Foam roller will be done during 2 minutes in each member. The intervention through the suction cups will be performed with the subject in prone position, on the stretcher. The suckers are placed in the proximal part where the posterior musculature of the leg originates and in the distal part of the biceps femoris, semitendinosus and semimembranous insertion. This administration of the suckers will be applied during a period of 7 minutes in each member. | Other | Suction cups |
| Foam rollerAlso: Hamstring flexibilityEach session will last 18 minutes, taking place two days a week, in a period of 4 weeks. The intervention will be carried out before starting the training session. The intervention through the self-administration of Foam roller has the objective of increasing the flexibility of the isquitibial musculature. The technique will be performed with the subject sitting on the floor, placing the Foam roller on the back of the thigh, requesting the athlete to perform cranial and caudal movements during the established time. The stretching exercise with the Foam roller will be done during 2 minutes in each member. | Other | Foam roller |
Primary outcome
Change from baseline elongation capacity of the hamstring musculature after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
The assessment of the elongation capacity of the hamstring musculature will be carried out by applying the Wells drawer or test. The subject will sit on the floor in front of the drawer, with the feet together and the plants resting on the front of the drawer, and the knees extended. Next, the athlete must tilt the trunk forward and extend the arms, sliding with outstretched hands until reaching the maximum stretch that allows its trunk flexion. The result that will be recorded corresponds to the point you can touch with your fingers. The unit of measurement for this test is the centimeter (the longer the length, the greater the hamstring elongation capacity).
2 secondary outcomes
Change from baseline ischithiobial extensibility after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline flexibility after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
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 27 Jan 2020.
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.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suction cups and Foam roller in people with Flexibility, Waxy, run by Investigación en Hemofilia y Fisioterapia 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 4 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: finished, as of the sponsor's last update on 27 Jan 2020. 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?
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?
Change from baseline elongation capacity of the hamstring musculature after treatment and at month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). 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 27 Jan 2020.