- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06034704
Plantar Fascia Release With Magnetic Fascia Ball
September 11, 2023 updated by: Ömer Osman Pala, Abant Izzet Baysal University
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bolu, Turkey, 14300
- Faculty of Health Sciences Bolu Abant Izzet Baysal University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Having scored 3 or less according to the Beighton scoring system
- 18-35 years old,
- Having asymptomatic
- Voluntary participation in the research
Exclusion Criteria:
- Having Beighton score of 4 and above
- Having history of previous surgery
- Having diagnosed pathology of the lower extremities and lumbar region
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Magnetic Fascial Ball
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.
|
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.
|
|
Placebo Comparator: Non-Magnetic Fascial Ball
In the placebo group, a fascial ball made of cork without magnets.
The non-magnetic fascia ball diameter is 6 centimetres.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Two times in one day (before intervention, immediately after intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sit and reach test
Time Frame: Two times in one day (before intervention, immediately after intervention)
|
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.
|
Two times in one day (before intervention, immediately after intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ömer Osman PALA, Bolu Abant İzzet Baysal Üniversitesi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
August 30, 2023
First Submitted That Met QC Criteria
September 11, 2023
First Posted (Actual)
September 13, 2023
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 11, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AIBU-FTR-OOP-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Muscle Tightness
-
Sakshi NegiGuru Nanak Dev UniversityCompletedHamstring Tightness | Muscle TightnessIndia
-
Riphah International UniversityCompletedMuscle TightnessPakistan
-
Riphah International UniversityCompletedEffects of Foam Rolling Versus Stretching Exercises on Quadriceps, Hamstrings and Calf Muscle LengthMuscle TightnessPakistan
-
Riphah International UniversityCompleted
-
Riphah International UniversityActive, not recruitingMuscle TightnessPakistan
-
BTL Industries Ltd.Withdrawn
-
Riphah International UniversityRecruitingMuscle TightnessPakistan
-
Maharishi Markendeswar University (Deemed to be...Completed
-
Jeffrey SykoraCompleted
-
BTL Industries Ltd.WithdrawnMuscle TightnessUnited States, Bulgaria
Clinical Trials on Plantar fascia self massage with a magnetic fascia ball
-
National Taiwan University HospitalUnknown
-
University of FaisalabadCompletedPlantar FasciitisPakistan
-
Riphah International UniversityRecruitingPlantar Fascitis | Resistance Training | Muscle Stretching ExercisesPakistan
-
Eastern Mediterranean UniversityRecruiting
-
University of British ColumbiaCompletedFasciitis, PlantarCanada
-
University Medical Center GroningenTerminatedParkinson's Disease | Apomorphine-induced Skin ReactionsNetherlands