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Application of the magnetic field in the resorption of postoperative edema after reconstruction of the anterior cruciate ligament

Application of the magnetic field in the resorption of postoperative edema after reconstruction of the anterior cruciate ligament: a randomized double-blinded clinical trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001025123
Enrollment
40
Registered
2019-07-17
Start date
2019-07-22
Completion date
2019-08-05
Last updated
2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the study will be to evaluate the effectiveness of magnetic field application in resorption of postoperative edema in patients after ACL reconstruction. The research group will be patients after ACL reconstruction. After the procedure, each patient will be randomly assigned a device emitting a magnetic field (the assignment of the device will be based on a simple randomization using a coin toss - the heads – the patient received the A device, the tails – the patient received the B device). Neither the patient nor the investigators will know which device emits a magnetic field. Research tools include measurement of lower limb circumferences (measurement by the knee and thigh (10 cm from the patellar base) and range of motion of knee joint and assessment of knee joint function using the Lysholm scale The first examination of the lower limb circuit will be performed before starting the magnetic field treatment, and then everyday for a period of 11 days, each time after the treatment with a magnetic field, the range of motion of the knee and the assessment of joint function will be assessed twice – before and after the therapy with a magnetic field.

Interventions

The first stage of the research will be the qualification of the patient for the ACL reconstruction performed by the orthopedic surgeon. The second stage of postoperative therapy will be dividing patients into two groups and randomly assigning each of them on the first day after the reconstruction a device emitting a magnetic field (the assignment of the device will be based on a simple randomization using a coin toss - the obverse - the patient received the A device, the reverse - the patient r

The first stage of the research will be the qualification of the patient for the ACL reconstruction performed by the orthopedic surgeon. The second stage of postoperative therapy will be dividing patients into two groups and randomly assigning each of them on the first day after the reconstruction a device emitting a magnetic field (the assignment of the device will be based on a simple randomization using a coin toss - the obverse - the patient received the A device, the reverse - the patient received the apparatus B). Neither the patient nor the investigators will know which device emits a magnetic field. For the next 11 days, each patient will have a magnetic field performed by the physiotherapist. The device is a knee brace that is strapped onto the participant. The magnetotherapy treatment will be performed daily at the same time by the same therapist. Patients will use the device for 30 minutes, and the magnetic field parameters in both devices will be the same - 3mT and 100Hz. The third stage of the research will be a functional examination including measurement of the lower limb circumferences (measurement by the knee and thigh (10 cm from the patellar base) and range of knee joint motion and assessment of knee joint function using the Lysholm scale. The first examinationof the lower limb circumferences will be made before the start of therapy with a magnetic field, and then every day for a period of 11 days, each time after the treatment with a magnetic field. The range of motion of the knee and the assessment of joint function will be evaluated twice - before and after the end of therapy with a magnetic field. Any changes in the progress of the intervention will be made by direct supervision of the physiotherapist. During the magnetic field application, patients of both groups will not perform any exercises of the operated joint, they will move on crutches and apply cooling the joint with ice cubes (2x daily for 15 min). Intervention adherence will be assessed by direct supervision

Sponsors

University of Physical Education in Krakow
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

1. Reconstruction technique determined by the attending physician - reconstruction of the cruciate ligament using the autogenous method - ST tendon graft. 2. No other injuries or illnesses that may affect the outcome of the tests (e.g. meniscus injury, degenerative changes in the joints of the leg). 3. A voluntary consent of the patient to participate in the study.

Exclusion criteria

1. Absenteeism in magnetic field treatments. 2. Interruption of the graft continuity. 3. Thrombosis of lower limb veins 4. Infections - concerns wounds on the skin as well as woven deeper 5. Other situations and conditions that exclude the patient from continuing the therapy.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026