Clinical trial NCT06870825: Assessment of Quadriceps Femoris Muscle Function in Patients After Arthroscopic Knee Surgery in Outpatient Rehabilitation
Official title: Assessment of Quadriceps Femoris Muscle Function in Patients After Arthroscopic Knee Surgery in Outpatient Rehabilitation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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:

1. To evaluate and check the quadriceps muscle volume, strength, knee joint motion amplitude, pain intensity before and after outpatient rehabilitation and to identify factors that may influence their occurrence.
2. To evaluate and compare the effectiveness of transcutaneous neuromuscular electrical stimulation and high-intensity magnetic field stimulation on changes in quadriceps muscle volume and strength in patients undergoing outpatient rehabilitation after knee joint arthroscopic surgeries.
3. To evaluate the impact of quadriceps muscle size and strength reduction on movement function and quality of life during outpatient rehabilitation, to evaluate changes in condition after outpatient rehabilitation and the previous 1 month, to compare the results obtained.
4. To establish and compare the tolerance of different muscle stimulation methods used and possible adverse reactions after arthroscopic knee joint surgeries.

Subject of the study:

Patients undergoing outpatient rehabilitation, according to the profile of musculoskeletal injuries, 14 days.

Eligibility criteria: Inclusion Criteria:

* 18 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

Exclusion Criteria:

* Contraindications to electrostimulation or high-intensity magnetic therapy:

  1. Epilepsy
  2. Implanted electrical devices
  3. Acute rhythm disorders
  4. Oncological diseases (near the stimulation site, active treatment)
  5. Sensory disorders
  6. Skin lesions (near the stimulation site)
  7. 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

Primary outcomes:
measure: Thigh circumference measurement with a centimeter tape (cm)
timeFrame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
measure: Ultrasound assessment of quadriceps muscle cross-sectional area
timeFrame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
measure: Muscle echogenicity assessed by ultrasound
timeFrame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
measure: Muscle strength/power (kg), assessed with a hand-held dynamometer
timeFrame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
measure: Knee joint pain intensity
timeFrame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Secondary outcomes:
measure: Range of motion through the knee joint
timeFrame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
measure: 6-minute walk test
timeFrame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
measure: Quality of life questionnaire
timeFrame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
measure: Tolerating of interventions
timeFrame: Assessments are performed at the beginning, end, and 1 month after rehabilitation.
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
References: