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Trial registered on ANZCTR


Registration number
ACTRN12619001025123
Ethics application status
Approved
Date submitted
23/05/2019
Date registered
17/07/2019
Date last updated
17/07/2019
Date data sharing statement initially provided
17/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Application of the magnetic field in the resorption of postoperative edema after reconstruction of the anterior cruciate ligament
Scientific title
Application of the magnetic field in the resorption of postoperative edema after reconstruction of the anterior cruciate ligament: a randomized double-blinded clinical trial
Secondary ID [1] 298318 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ACL reconstruction 312955 0
Condition category
Condition code
Musculoskeletal 311451 311451 0 0
Other muscular and skeletal disorders
Injuries and Accidents 311665 311665 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 314555 0
Treatment: Devices
Comparator / control treatment
The control group will have the same intervention, because until the tests are completed, it will not be known which device emits a magnetic field.
Placebo device is the same to the intervention device except that it does not provide a magnetic field,
Control group
Placebo

Outcomes
Primary outcome [1] 320166 0
Measurement of knee circumference using a centimeter tape.
Timepoint [1] 320166 0
On the day of therapy with the magnetic field and for the next 11 days.
Primary outcome [2] 320167 0
Measurement of the range of motion of the knee using a goniometer.
Timepoint [2] 320167 0
Measurement performed on the first and last day of therapy with a magnetic field.
Primary outcome [3] 320367 0
Measurement of thigh circumference using a centimeter tape.
Timepoint [3] 320367 0
On the day of therapy with the magnetic field and for the next 11 days.
Secondary outcome [1] 370754 0
Assessment of the knee function using the Lysholm scale.
Timepoint [1] 370754 0
Assessment of knee joint function performed on the first and last day of therapy with a magnetic field.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis will be developed using Statistica 10 software. Methods of descriptive statistics will be used to present the results in the form of tables containing arithmetic means, standard deviation, minimum and maximum values.
The first stage of the analysis will be the assessment of the distribution of observed values of the lower limb circuits using the Shapiro-Wilk test. Then, the observed values will be checked for equality of variance. For this purpose, the Fisher-Snedecor test will be used.
In order to compare the distribution of variables between particular groups of the lower limb study in the following days, the Student's t-test for independent samples will be used. In order to determine the change in time of the size of the edema within a given group, an analysis of variance for a dependent group (repeated measurements) using the post-hoc tests (Tukey's test) will also be performed. The significance level of p> 0.05 will be assumed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21523 0
Poland
State/province [1] 21523 0
Malopolska

Funding & Sponsors
Funding source category [1] 302859 0
University
Name [1] 302859 0
University of Physical Education in Krakow
Address [1] 302859 0
Al. Jana Pawla II 78
31-571 Krakow
Country [1] 302859 0
Poland
Primary sponsor type
University
Name
University of Physical Education in Krakow
Address
Al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 302811 0
None
Name [1] 302811 0
None
Address [1] 302811 0
None
Country [1] 302811 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303434 0
Bioethics Commission at the Regional Medical Chamber in Krakow
Ethics committee address [1] 303434 0
ul. Krupnicza 11a
31-123 Krakow
Ethics committee country [1] 303434 0
Poland
Date submitted for ethics approval [1] 303434 0
02/04/2014
Approval date [1] 303434 0
08/04/2014
Ethics approval number [1] 303434 0
No. 19/KBL/OIL/2014

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93658 0
Dr Katarzyna Ogrodzka-Ciechanowicz
Address 93658 0
University of Physical Education in Krakow
Al. Jana Pawla II 78
31-571 Krakow
Country 93658 0
Poland
Phone 93658 0
+48126831065
Fax 93658 0
Email 93658 0
katarzynaogrodzka@wp.pl
Contact person for public queries
Name 93659 0
Dr Katarzyna Ogrodzka-Ciechanowicz
Address 93659 0
University of Physical Education in Krakow
Al. Jana Pawla II 78
31-571 Krakow
Country 93659 0
Poland
Phone 93659 0
+48126831065
Fax 93659 0
Email 93659 0
katarzynaogrodzka@wp.pl
Contact person for scientific queries
Name 93660 0
Dr Katarzyna Ogrodzka-Ciechanowicz
Address 93660 0
University of Physical Education in Krakow
Al. Jana Pawla II 78
31-571 Krakow
Country 93660 0
Poland
Phone 93660 0
+48126831065
Fax 93660 0
Email 93660 0
katarzynaogrodzka@wp.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
lack of consent of the patients (reserved by the local bioethics commission) for IPD
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2162 0
Ethical approval
Citation [1] 2162 0
Link [1] 2162 0
Email [1] 2162 0
Other [1] 2162 0
Summary results
No Results