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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-15

Study Completion Date

2026-09-15

Brief Summary

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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.

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Detailed Description

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Background: Bone marrow edema is a reversible stress-related bone injury in athletes, causing localized pain during loading and confirmed by MRI, the gold standard for diagnosis and monitoring. Grades 2 and 3 of the Fredericson classification represent clinically significant edema without a fracture line and are managed conservatively through physiotherapy including exercise, manual techniques, and gradual reloading. Functional Magnetic Stimulation (FMS) is a non-invasive method that induces deep neuromuscular activation and improves circulation. Although increasingly used in musculoskeletal rehabilitation, its effect on recovery from bone marrow edema has not yet been tested in a controlled clinical setting.

Aim: The aim of the present randomized controlled clinical trial is to evaluate the effectiveness of adding Functional Magnetic Stimulation to a structured physiotherapy rehabilitation program in athletes with MRI-confirmed bone marrow edema of the lower limb. The primary objective is to determine whether the combined approach results in greater clinical improvement, superior functional recovery, and faster radiological resolution of edema compared with physiotherapy alone.

Method: Forty athletes with lower-limb bone marrow edema graded as Fredericson 2 or 3 on MRI will be randomly assigned to two groups. The intervention group will follow a four-week physiotherapy program combining therapeutic exercise, manual therapy, and unloading techniques with Functional Magnetic Stimulation applied twice weekly. The control group will receive the same physiotherapy without FMS. Assessments will occur at baseline, two, four, and sixteen weeks, including pain (NRS 0-10), functional ability (LEFS-GR), and readiness for return to sport (Tegner scale). MRI at baseline, week 4, and week 16 will evaluate Fredericson grade, edema intensity, and edema extent. All parameters are predefined as primary outcomes. Data will be analyzed with mixed-model ANOVA for repeated measures with the significance level set at p \< .05.

Expected Results: It is anticipated that athletes receiving Functional Magnetic Stimulation in addition to physiotherapy will show greater pain reduction, improved lower-limb function, faster MRI-documented resolution of bone marrow edema, and earlier readiness to return to sport compared with physiotherapy alone.

Conditions

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Bone Marrow Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A single-assessor-blind randomized controlled trial lasting four weeks, with a twelve-week follow-up, will be conducted on forty athletes diagnosed with MRI-confirmed bone marrow edema of the lower limb graded as Fredericson 2 or 3. Participants will be randomly allocated into two groups of twenty each (intervention and control). The intervention group will receive a combined treatment consisting of a standardized physiotherapy rehabilitation program and Functional Magnetic Stimulation (two sessions per week for four weeks), while the control group will follow the same physiotherapy protocol without FMS. Clinical assessments of pain and functional ability will be performed at baseline, at two weeks, at the end of the four-week intervention, and at sixteen weeks to monitor short- and medium-term recovery. MRI will be conducted at baseline, week 4, and week 16 to document radiological changes in bone marrow edema.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

A masked assessor will conduct the measurements

Study Groups

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Physiotherapy plus Functional Magnetic Stimulation (FMS)

Participants allocated to this group will receive 12 sessions of a conventional physiotherapy protocol and 8 sessions of FMS.

Group Type EXPERIMENTAL

Conventional Physiotherapy with FMS

Intervention Type OTHER

Participants will receive a standardized four-week physiotherapy program, three sessions per week (12 sessions in total), each lasting approximately 45 minutes. Treatment will include therapeutic exercise for progressive strengthening and flexibility, manual therapy for pain modulation, and unloading-reloading strategies to restore functional load tolerance. Exercises will be tailored to the recovery stage, and participants will be instructed on home exercises and activity modification.

In addition, participants will receive Functional Magnetic Stimulation (FMS) twice weekly for four weeks (eight sessions in total). Each session will last 30 minutes. FMS will be applied directly over the affected region using a fixed frequency of 40 Hz without modulation. The stimulation duty cycle will consist of an active phase of 3 seconds followed by a rest period of 6 seconds. Intensity will be gradually adjusted to patient tolerance avoding scomfort or excessive contraction.

Physiotherapy without Functional Magnetic Stimulation (FMS)

Participants allocated to this group will receive 12 sessions of a conventional physiotherapy protocol without the FMS

Group Type ACTIVE_COMPARATOR

Conventional Physiotherapy without FMS

Intervention Type OTHER

Participants in this group will follow the same conventional physiotherapy protocol as the first group, without the application of FMS

Interventions

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Conventional Physiotherapy with FMS

Participants will receive a standardized four-week physiotherapy program, three sessions per week (12 sessions in total), each lasting approximately 45 minutes. Treatment will include therapeutic exercise for progressive strengthening and flexibility, manual therapy for pain modulation, and unloading-reloading strategies to restore functional load tolerance. Exercises will be tailored to the recovery stage, and participants will be instructed on home exercises and activity modification.

In addition, participants will receive Functional Magnetic Stimulation (FMS) twice weekly for four weeks (eight sessions in total). Each session will last 30 minutes. FMS will be applied directly over the affected region using a fixed frequency of 40 Hz without modulation. The stimulation duty cycle will consist of an active phase of 3 seconds followed by a rest period of 6 seconds. Intensity will be gradually adjusted to patient tolerance avoding scomfort or excessive contraction.

Intervention Type OTHER

Conventional Physiotherapy without FMS

Participants in this group will follow the same conventional physiotherapy protocol as the first group, without the application of FMS

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Athletes aged 18-45 years participating in regular sports training ≥3 sessions per week for the past 6 months.
* MRI-confirmed bone marrow edema (BME) of the lower limb graded as Fredericson 2 or 3.
* Onset of pain or symptoms within the previous 6 weeks.
* Pain intensity ≥4/10 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.

Exclusion Criteria

* Fredericson grade 4 or evidence of a fracture line on MRI. Bone marrow edema secondary to infection, tumor, or systemic inflammatory disease.
* History of recent fracture, surgery, or intra-articular injection in the affected limb within 12 weeks.
* Prior exposure to 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No