Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
NCT07234084

Functional Magnetic Stimulation (FMS) for Bone Marrow Edema in Athletes

Led by International Hellenic University · Updated on 2025-11-18

40

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This randomized controlled trial investigates the effectiveness of Functional Magnetic Stimulation (FMS) as an adjunct to physiotherapy in athletes with MRI-confirmed bone marrow edema of the lower limb. Forty athletes with Fredericson grade 2-3 edema will be randomly assigned to receive either physiotherapy plus FMS or physiotherapy alone for four weeks. Clinical, functional, and imaging assessments will be conducted up to 16 weeks. Primary outcomes include pain intensity, lower-limb function, return-to-sport readiness, and MRI indicators of bone marrow edema. The study aims to determine whether adjunctive FMS enhances recovery and accelerates the resolution of bone marrow edema compared with standard physiotherapy.

CONDITIONS

Official Title

Functional Magnetic Stimulation (FMS) for Bone Marrow Edema in Athletes

Who Can Participate

Age: 18Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Athletes aged 18-45 years participating in regular sports training 63 sessions per week for the past 6 months
  • MRI-confirmed bone marrow edema of the lower limb graded as Fredericson 2 or 3
  • Pain or symptoms started within the previous 6 weeks
  • Pain intensity 64 out of 10 on the Numeric Rating Scale during loading activity
  • Ability to comply with the 4-week intervention and 16-week follow-up assessments
  • Written informed consent provided prior to participation
Not Eligible

You will not qualify if you...

  • Fredericson grade 4 or evidence of a fracture line on MRI
  • Bone marrow edema caused by infection, tumor, or systemic inflammatory disease
  • History of recent fracture, surgery, or intra-articular injection in the affected limb within 12 weeks
  • Prior Functional Magnetic Stimulation or Extracorporeal Shockwave Therapy within 8 weeks before enrollment
  • Presence of metallic implants, pacemaker, or other contraindications to magnetic stimulation
  • Pregnancy or breastfeeding
  • Use of systemic corticosteroids or medications affecting bone metabolism
  • Any neurological, metabolic, or cardiovascular condition interfering with safe participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Physiotherapy, Faculty of Health Sciences International Hellenic University

Thessaloniki, Sindos, Greece, 57400

Actively Recruiting

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Research Team

D

Dimitrios Lytras, PhD

CONTACT

P

Paris Iakovidis, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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