Plantar Fascia Release With Magnetic Fascia Ball

• ClinicalTrials.gov Identifier: NCT06034704
• Recruitment Status: Completed
• First Posted: September 13, 2023
• Last Update Posted: September 13, 2023
• Sponsor: Abant Izzet Baysal University
• Information provided by (Responsible Party): Ömer Osman Pala, Abant Izzet Baysal University

Tracking Information

• First Submitted Date: August 30, 2023
• First Posted Date: September 13, 2023
• Last Update Posted Date: September 13, 2023
• Actual Study Start Date: June 1, 2021
• Actual Primary Completion Date: September 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 11, 2023)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 11, 2023)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Plantar Fascia Release With Magnetic Fascia Ball
• Official Title: Investigation of the Effect of Plantar Fascia Release With Magnetic Fascia Ball on Hamstring and Lumbar Spine Flexibility
• Brief 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Flexibility
• Muscle Tightness

Intervention

• Other: Plantar fascia self massage with a magnetic fascia ball
  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.
• Other: Plantar fascia self massage with a non-magnetic fascia ball
  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 Arms

• 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.
  Intervention: Other: Plantar fascia self massage with a magnetic fascia ball
• 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.
  Intervention: Other: Plantar fascia self massage with a non-magnetic fascia ball

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 11, 2023): 32
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 30, 2021
• Actual Primary Completion Date: September 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT06034704
• Other Study ID Numbers: AIBU-FTR-OOP-1
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ömer Osman Pala, Abant Izzet Baysal University
• Original Responsible Party: Same as current
• Current Study Sponsor: Abant Izzet Baysal University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ömer Osman PALA; Bolu Abant İzzet Baysal Üniversitesi

• PRS Account: Abant Izzet Baysal University
• Verification Date: September 2023