FlexibilityNCT06034704
Plantar Fascia Release With Magnetic Fascia Ball
A study testing Plantar fascia self massage with a magnetic fascia ball and Plantar fascia self massage with a non-magnetic fascia ball in people with Flexibility and Muscle Tightness, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effect of plantar fascia release with a magnetic fascial cork ball on hamstring and lumbar extensor muscle elasticity will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Flexibility, Muscle Tightness
- What is being tested?
- Plantar fascia self massage with a magnetic fascia ball and Plantar fascia self massage with a non-magnetic fascia ball
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 30 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having scored 3 or less according to the Beighton scoring system
- 18-35 years old,
- Having asymptomatic
- Voluntary participation in the research
Who cannot join
- Having Beighton score of 4 and above
- Having history of previous surgery
- Having diagnosed pathology of the lower extremities and lumbar region
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences Bolu Abant İzzet Baysal University
Bolu, 14300
About this study
Official title: Investigation of the Effect of Plantar Fascia Release With Magnetic Fascia Ball on Hamstring and Lumbar Spine Flexibility
In this study, the effect of plantar fascia release with a magnetic fascial cork ball on hamstring and lumbar extensor muscle elasticity will be investigated.
Read the detailed description
The use of tools such as foam rollers or massage balls to resolve myofascial tension is highly preferred by both therapists and patients. It is theorized that the sweeping pressure generated during rolling causes the fascia to stretch and increase the range of motion. In addition, the warming caused by the friction during rolling can dissolve the adhesions between the fascial layers and restore the elasticity of the myofascial tissues. In addition to similar mechanical effects, the use of cork balls with magnetic properties is becoming increasingly common. Studies have shown that static magnetic magnets reduce pain, increase microcirculation and oxygenation and cause changes in presynaptic membrane function. As far as we know, there is no study examining the myofascial relaxation effect of magnetic balls in the literature. Evaluating the clinical impact and efficacy of this device which allow the person to perform self-massage might contribute the current literature. This study was planned to evaluate the myofascial relaxation caused by two different fascial cork balls with and without magnetic properties.
- Conditions
- Flexibility, Muscle Tightness
- Being tested
- Plantar fascia self massage with a magnetic fascia ball, Plantar fascia self massage with a non-magnetic fascia ball
- Keywords
- Massage, Hamstring Muscles, Magnets, Lumbar Fascia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plantar fascia self massage with a magnetic fascia ballOther
Participants were asked to roll the magnetic fascia ball on the sole of each foot for 3 minutes each, from the metatarsal heads towards the heel, concentrating on the medial longitudinal arch. Participants were informed that more intense pressure would be more beneficial and were asked to apply pressure in a way that would not cause pain.
Plantar fascia self massage with a non-magnetic fascia ballOther
Participants were asked to roll the non-magnetic fascia ball on the sole of each foot for 3 minutes each, from the metatarsal heads towards the heel, concentrating on the medial longitudinal arch. Participants were informed that more intense pressure would be more beneficial and were asked to apply pressure in a way that would not cause pain.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Fascial Ball | Experimental | In the experimental group, a fascial ball made of cork containing 3 magnets of 0.15 tesla was used. The magnetic fascia ball diameter is 6 centimetres. Receives: Other: Plantar fascia self massage with a magnetic fascia ball |
| Non-Magnetic Fascial Ball | Placebo comparator | In the placebo group, a fascial ball made of cork without magnets. The non-magnetic fascia ball diameter is 6 centimetres. Receives: Other: Plantar fascia self massage with a non-magnetic fascia ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometric Measurement of Hamstring Flexibility
Individuals are positioned supine with the hip of the limb to be measured at 90 degrees. In this position, active knee extension is requested and the acute angle between the long axis of the femur and the long axis of the fibula is measured. The DrGonyometer (iOS) smart phone application, for which a validity and reliability study was conducted, was used for the measurement.
Measured: Two times in one day (before intervention, immediately after intervention)
Secondary outcomes (1)
Sit and reach test
Individuals are placed in a long sitting position with their feet resting on the test battery (Figure 2) and knees in full extension. They are asked to reach forward on the wooden block by placing their hands on top of each other. In this position, the distance between the fingers of the hand and the point where the foot rests is measured and the previous values are recorded as negative and the following values as positive.
Measured: Two times in one day (before intervention, immediately after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Jun 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlexibilityStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Osman Pala, Abant Izzet Baysal University
- Investigators
- Ömer Osman PALA, Principal investigator, Bolu Abant İzzet Baysal Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034704
- Sponsor's protocol ID
- AIBU-FTR-OOP-1
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Plantar Fascia Release With Magnetic Fascia Ball on Hamstring and Lumbar Spine Flexibility
- ClinicalTrials.gov ID
- NCT06034704
- Acronym / sponsor ID
- AIBU-FTR-OOP-1
- Conditions
- Flexibility, Muscle Tightness
- Keywords
- Massage, Hamstring Muscles, Magnets, Lumbar Fascia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 13 Sep 2023 (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.
In this study, the effect of plantar fascia release with a magnetic fascial cork ball on hamstring and lumbar extensor muscle elasticity will be investigated.
Detailed description
The use of tools such as foam rollers or massage balls to resolve myofascial tension is highly preferred by both therapists and patients. It is theorized that the sweeping pressure generated during rolling causes the fascia to stretch and increase the range of motion. In addition, the warming caused by the friction during rolling can dissolve the adhesions between the fascial layers and restore the elasticity of the myofascial tissues. In addition to similar mechanical effects, the use of cork balls with magnetic properties is becoming increasingly common. Studies have shown that static magnetic magnets reduce pain, increase microcirculation and oxygenation and cause changes in presynaptic membrane function. As far as we know, there is no study examining the myofascial relaxation effect of magnetic balls in the literature. Evaluating the clinical impact and efficacy of this device which allow the person to perform self-massage might contribute the current literature. This study was planned to evaluate the myofascial relaxation caused by two different fascial cork balls with and without magnetic properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic Fascial Ball | Experimental | Other: Plantar fascia self massage with a magnetic fascia ballIn the experimental group, a fascial ball made of cork containing 3 magnets of 0.15 tesla was used. The magnetic fascia ball diameter is 6 centimetres. |
| Non-Magnetic Fascial Ball | Placebo comparator | Other: Plantar fascia self massage with a non-magnetic fascia ballIn the placebo group, a fascial ball made of cork without magnets. The non-magnetic fascia ball diameter is 6 centimetres. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having scored 3 or less according to the Beighton scoring system
- 18-35 years old,
- Having asymptomatic
- Voluntary participation in the research
Key exclusion criteria (3 listed)
- Having Beighton score of 4 and above
- Having history of previous surgery
- Having diagnosed pathology of the lower extremities and lumbar region
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 |
|---|---|---|
| Plantar fascia self massage with a magnetic fascia ballParticipants were asked to roll the magnetic fascia ball on the sole of each foot for 3 minutes each, from the metatarsal heads towards the heel, concentrating on the medial longitudinal arch. Participants were informed that more intense pressure would be more beneficial and were asked to apply pressure in a way that would not cause pain. | Other | Magnetic Fascial Ball |
| Plantar fascia self massage with a non-magnetic fascia ballParticipants were asked to roll the non-magnetic fascia ball on the sole of each foot for 3 minutes each, from the metatarsal heads towards the heel, concentrating on the medial longitudinal arch. Participants were informed that more intense pressure would be more beneficial and were asked to apply pressure in a way that would not cause pain. | Other | Non-Magnetic Fascial Ball |
Primary outcome
Goniometric Measurement of Hamstring Flexibility
Time frame: Two times in one day (before intervention, immediately after intervention)
Individuals are positioned supine with the hip of the limb to be measured at 90 degrees. In this position, active knee extension is requested and the acute angle between the long axis of the femur and the long axis of the fibula is measured. The DrGonyometer (iOS) smart phone application, for which a validity and reliability study was conducted, was used for the measurement.
1 secondary outcome
Sit and reach test
Time frame: Two times in one day (before intervention, immediately after intervention)
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 13 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Ömer Osman PALA principal investigator
Bolu Abant İzzet Baysal Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plantar fascia self massage with a magnetic fascia ball and Plantar fascia self massage with a non-magnetic fascia ball in people with Flexibility and Muscle Tightness, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 3 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 13 Sep 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Goniometric Measurement of Hamstring Flexibility (time frame: Two times in one day (before intervention, immediately after intervention)). 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 13 Sep 2023.