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The goal of this clinical trial is to learn if a high intensity magnetic field is an effective way to treat quadriceps muscle atrophy after knee arthroscopic surgery in adult patients. The main questions it aims to answer are:
Is high intensity magnetic field muscle stimulation is an effective way to treat quadriceps muscle atrophy Is high intensity magnetic field muscle stimulation is more effective and more tolerable option for quadriceps muscle stimulation than transcutaneous muscle electrical stimulation Researchers will compare high intensity magnetic field muscle stimulation to transcutaneous muscle electrical stimulation and control group, to see if high intensity magnetic field muscle stimulation works to treat quadriceps muscle atrophy.
Participants will:
receive high intensity magnetic field or transcutaneous muscle electrical stimulation 1 time/day for 14 days, Visit the rehabilitation department for testing before/after and 1 month after rehabilitation.
The purpose of this study is to evaluate the effectiveness of quadriceps muscle stimulation methods: transcutaneous neuromuscular electrostimulation (standard methodology) and high-intensity magnetic field (innovative methodology) stimulation in the rehabilitation of patients after arthroscopic knee surgery, and the impact of the applied methods on the quality of life.
Objectives:
Subject of the study:
Patients undergoing outpatient rehabilitation, according to the profile of musculoskeletal injuries, 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-intensity magnetic field muscle stimulation group | Experimental | Group will receive High-intensity magnetic field muscle stimulation group to treat quadriceps muscle atrophy |
|
| Transcutaneous neuromuscular electrical stimulation group | Active Comparator | Group will receive a Transcutaneous neuromuscular electrical stimulation to treat quadriceps muscle atrophy |
|
| Control group | No Intervention | A Control group, that will receive a standard outpatient rehabilitation plan, without additional quadriceps muscle stimulation methodology. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-intensity Magnetic Field Muscle Stimulation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thigh circumference measurement with a centimeter tape (cm) | Measuring thigh circumference using a centimeter tape (cm) is a simple yet effective way to track changes in muscle mass, body composition, or to monitor progress. In order to obtain accurate data, the distance between the anterior angle of the iliac wing and the upper edge of the patella is measured with a centimeter tape. Mark the point: ⅓ from the edge of the patella. At the marked point, the thigh circumference is estimated with a centimeter tape, the measurement is repeated 3 times, and the average of the measurements is derived. | Assessments are performed at the beginning, end, and 1 month after rehabilitation. |
| Ultrasound assessment of quadriceps muscle cross-sectional area | Ultrasound (Mindray DC-80a device) Subject position: During the study, the subject lies on his back, with the knee joints in 15° passive flexion (a cushion is used under the knee joints). During the study, the participants were instructed to relax the thigh muscles. Measurements are performed after the subject has been in a horizontal position for 5 min., to determine the distribution of body fluids [Berg et al., 1993]. Assessment methodology: in order to obtain accurate data, the distance between the greater trochanter of the femur and the upper edge of the patella is measured with a centimeter tape. A point is marked in the distal quarter (75% of the total distance). At the marked point, the ultrasound transducer is placed perpendicular to the longitudinal axis of the thigh on the medial surface, the edge of the quadriceps muscle VM is visualized, and from the starting point, a continuous single image is scanned with the transducer traveling transversely across the thigh along the m | Assessments are performed at the beginning, end, and 1 month after rehabilitation. |
| Muscle echogenicity assessed by ultrasound | is performed using an ultrasound device (Mindray, DC-80a), in order to obtain accurate data, the distance between the greater trochanter of the femur and the upper edge of the patella is measured with a centimeter tape. A point is marked in the distal quarter (75% of the total distance). At the marked points, the ultrasound transducer is placed perpendicular to the longitudinal axis of the thigh. At the mentioned points, the heads of the quadriceps muscle are visualized, with clear contours, and the image is captured. The image is processed by the ImageJ program, and the visual quantitative scale (VAS echogenicity) is evaluated from 0 to 100. |
| Measure | Description | Time Frame |
|---|---|---|
| Range of motion through the knee joint | Active range of motion through the joints is measured with a plastic goniometer (SEAHAN® Grid, 360° per 1° 20 cm) using the neutral zero method. The minimum significant change in range of motion is 5°. The measurements will be repeated three times. After adding all the results obtained during one measurement, the arithmetic mean is calculated. | Assessments are performed at the beginning, end, and 1 month after rehabilitation. |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to electrostimulation or high-intensity magnetic therapy:
Cannot perform the functional tests presented in the study.
Subjects who cannot be treated with a standardized outpatient rehabilitation plan due to other contraindications (e.g. IC, DVT)
Subjects who refuse to participate in the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lithuanian University of Health Sciences | Kaunas | Lithuania |
For now, we do not have enough human and financial resources to share IPD, but if our circumstances change, we are open to reconsider this decision.
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|
| Transcutaneous Neuromuscular Electrical Stimulation | Device |
|
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| Assessments are performed at the beginning, end, and 1 month after rehabilitation. |
| Muscle strength/power (kg), assessed with a hand-held dynamometer | Quadriceps muscle strength will be assessed manually using a manual muscle testing device - Lafayette. Measurements are performed with the subject sitting; the back is supported, the pelvis and knees are bent at an angle of 90°. Then the subjects voluntarily perform 3 consecutive maximal voluntary extensions through the knee joint. (contraction time 3 sec., rest time 7 sec.), the highest value during the assessment was considered the maximal force. | Assessments are performed at the beginning, end, and 1 month after rehabilitation. |
| Knee joint pain intensity | Pain at rest and during movement will be assessed using the visual analogue scale (VAS)-a line marked with dashes and marked with 11 numbers, from 0 to 10. The subject will be asked to mark a number that indicates the intensity of the pain experienced. Pain is assessed on a scale of 0 to 10, where 0 is no pain, 1, 2, 3 is mild pain, 4, 5, 6 is severe pain, 7, 8, 9 is very severe pain, and 10 is unbearable pain. | Assessments are performed at the beginning, end, and 1 month after rehabilitation. |
| 6-minute walk test | The test was used to assess the level of physical fitness. Subjects were asked to walk at their usual maximum pace along a 30-meter long, level, straight hospital corridor without encouragement. The test measured the distance the patient walked in 6 minutes. | Assessments are performed at the beginning, end, and 1 month after rehabilitation. |
| Quality of life questionnaire | The European Quality of Life and Health Status Questionnaire (EQ-5D-3L) is a standardized quality of life and health status assessment scale developed by the international EuroQoL group. This questionnaire consists of two parts: i. a descriptive part of 5 questions, in which the subject rates his/her health status in 5 dimensions: mobility, self-care, usual activities, pain or discomfort, anxiety or depression, choosing from three options (no problems, some problems or moderate pain, major problems); ii. a visual analogue scale, in which the subject is asked to rate his/her health status on a scale from 0 to 100, where 100 is the highest rating and 0 is the lowest. | Assessments are performed at the beginning, end, and 1 month after rehabilitation. |
| Tolerating of interventions | Patients are asked to answer the following questions posed by the researcher:
| Assessments are performed at the beginning, end, and 1 month after rehabilitation. |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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