Assessment of Quadriceps Femoris Muscle Function in Patients After Arthroscopic Knee Surgery in Outpatient Rehabilitation

NCT06870825 | Active Not Recruiting

• 1 other identifier: P2-BE-2-60/2024
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meniscus Injury; Meniscus Tear; Arthroscopic Knee Surgeries; ACL Injuries

Keywords

arthroscopic knee surgery; quadriceps femoris atrophy; neuromuscular electrical stimulation; high intensity magnetic field stimulation

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

Secondary Outcomes (4)

• Range of motion through the knee joint

  Assessments are performed at the beginning, end, and 1 month after rehabilitation.

• 6-minute walk test

  Assessments are performed at the beginning, end, and 1 month after rehabilitation.

• Quality of life questionnaire

  Assessments are performed at the beginning, end, and 1 month after rehabilitation.

• Tolerating of interventions

  Assessments are performed at the beginning, end, and 1 month after rehabilitation.

Study Arms (3)

High-intensity magnetic field muscle stimulation group

EXPERIMENTAL

Group will receive High-intensity magnetic field muscle stimulation group to treat quadriceps muscle atrophy

Device: High-intensity Magnetic Field Muscle Stimulation

Transcutaneous neuromuscular electrical stimulation group

ACTIVE COMPARATOR

Group will receive a Transcutaneous neuromuscular electrical stimulation to treat quadriceps muscle atrophy

Device: Transcutaneous Neuromuscular Electrical Stimulation

Control group

NO INTERVENTION

A Control group, that will receive a standard outpatient rehabilitation plan, without additional quadriceps muscle stimulation methodology.

Interventions

High-intensity Magnetic Field Muscle Stimulation DEVICE

1. The procedure is performed for 20 min., 1k/d, 5k/week, a total of 14 times (rehabilitation duration 14 days). 2. Parameters: applied parameters according to the manufacturer's specified program for muscle stimulation: "muscle strengthening" program 3. Stimulation site: quadriceps femoris muscle, applied above the motor point approximately 60% of the distance from the upper medial border of the patella to the anterior upper wing of the iliac bone. 4. device: BLT Super Inductive System * Along with muscle stimulation techniques, all subjects will undergo a standardized outpatient rehabilitation plan.

High-intensity magnetic field muscle stimulation group

Transcutaneous Neuromuscular Electrical Stimulation DEVICE

1. the procedure is performed for 20 min., 1k/d, 5k/week, a total of 14 times (rehab. duration 14 days). 2. Parameters: applied parameters according to the manufacturer's specified program for muscle stimulation (EMS, P3) 3. Stimulation site: quadriceps femoris muscle, applied above the motor point. 4. device: ITO ES-5200 * Along with muscle stimulation techniques, all subjects will undergo a standardized outpatient rehabilitation plan.

Transcutaneous neuromuscular electrical stimulation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older (working age).
• Arthroscopic knee joint surgery performed
• The dr. orthopedic traumatologist allowed the operated limb to be activated - and rehabilitation to begin
• The period between the operation and the start of rehabilitation is not shorter than 4 weeks and not longer than 2 months.
• Impaired self-service or movement function: Barthel index 80 points or more (according to the order of the Ministry of Health of the Republic of Lithuania) Subjects agreeing to participate in the study

You may not qualify if:

• Contraindications to electrostimulation or high-intensity magnetic therapy:
• Epilepsy
• Implanted electrical devices
• Acute rhythm disorders
• Oncological diseases (near the stimulation site, active treatment)
• Sensory disorders
• Skin lesions (near the stimulation site)
• Pregnancy.
• 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

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant teacher, phd student.

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 11, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)