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Undersøgelse af effekten af ​​overlejret neuromuskulær elektrisk stimulering hos patienter med knæartrose.

22. september 2026 opdateret af: Mustafa Ertuğrul Yaşa, Gulhane School of Medicine

Undersøgelse af effekten af ​​overlejret neuromuskulær elektrisk stimulering med aktiv kontraktion hos patienter med knæartrose.

The aim of the study is to investigate the effects of superimposed neuromuscular electrical stimulation with active contraction on physical function, muscle and joint structure, functionality, and quality of life in patients with knee osteoarthritis.

Studieoversigt

Detaljeret beskrivelse

Osteoarthritis (OA) is a progressive joint disease that can affect all structures that make up the joint, especially cartilage. The frequency of OA increases with age and can especially affect weight-bearing joints such as the knee and hip joints. The main symptoms of knee OA are pain, decreased joint range of motion (ROM), decreased muscle strength, functional loss, and limitation in daily living activities. However, studies conducted in individuals with knee OA report a decrease in quadriceps muscle and knee joint cartilage thickness and impairment in sensorimotor function (proprioception and balance).

Many pharmacological and non-pharmacological methods are used in symptom management of knee OA. In this context, physiotherapy and rehabilitation are among the frequently used non-pharmacological methods. Exercise, manual therapy, taping, aqua therapy, thermal therapy, and electrotherapy are the basic physiotherapy modalities used in OA symptom management. Electrotherapy involves many different agents with different therapeutic purposes. One of these is Neuromuscular Electrical Stimulation (NMES). NMES is a non-invasive method that activates intramuscular nerve branches through surface electrodes placed on skeletal muscles and produces observable contractions. Although its most important therapeutic purpose is muscle stimulation, it also has contributions such as pain relief and sensory stimulation. Superimposed NMES technique (active NMES) is the use of NMES with voluntary muscle contraction. In superimposed NMES with active contraction, the patient is asked to actively contract the relevant muscle during each stimulation. Thus, exercise is performed simultaneously during electrotherapy application. When the literature is examined, there is no study investigating the effect of superimposed NMES with active contraction in patients with knee OA. In this context, the aim of this study is to investigate the effect of superimposed NMES with active contraction on physical function, muscle and joint structure, functionality and quality of life in patients with knee osteoarthritis.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

63

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Etlik
      • Ankara, Etlik, Tyrkiet (Türkiye), 06018
        • Faculty of Physiotherapy and Rehabilitation, University of Health Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Having grade 2-3 knee osteoarthritis according to Kellgren and Lawrence Classification,
  • Being between the ages of 40-65, ,
  • Being literate
  • Volunteer

Exclusion Criteria:

  • Having Grade 2 or higher osteoarthritis in the hip, ankle, or foot joint Presence of a history of knee-related surgery (arthroplasty, meniscectomy, etc.)
  • Having a deformity in the waist, leg, hip, knee, or ankle
  • Having any inflammatory rheumatic, neurological, vestibular, cardiopulmonary disease
  • Having active knee joint synovitis
  • BMI>40
  • Having a condition that is contraindicate for electrotherapy (malignancy, pacemaker, epilepsy, deep vein thrombosis, loss of protective sensation, etc.)
  • Having received physiotherapy in the last 3 months
  • Being diagnosed with a psychiatric disease
  • Having a cooperation problem that makes it difficult to comply with evaluation and treatment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: conventional physiotherapy

Demographic and medical information of the patients (age, gender, height and body weight, occupation, educational status, CV, family history and surgical history, medical history related to knee osteoarthritis) and pain level will be questioned. Conventional physiotherapy modalities will be applied in the group; exercise training, hotpack, ultrasound and transcutaneous electrical nerve stimulation (TENS). Patients will be treated for one hour, three days a week, for eight weeks.

The physical functions, muscle structure and knee joint cartilage thickness, quality of life and functional status of the patients will be evaluated before and after treatment.

Conventional physiotherapy is a treatment method that includes exercise training, hotpack, ultrasound and TENS (electrotherapy) applications.

Aktiv komparator: NMES

Demographic and medical information of the patients (age, gender, height and body weight, occupation, educational status, CV, family history and surgical history, medical history related to knee osteoarthritis) and pain level will be questioned. In addition to conventional physiotherapy methods, passive NMES treatment will be applied in the group.Patients will be treated for one hour, three days a week, for eight weeks.

The physical functions, muscle structure and knee joint cartilage thickness, quality of life and functional status of the patients will be evaluated before and after treatment.

Conventional physiotherapy is a treatment method that includes exercise training, hotpack, ultrasound and TENS (electrotherapy) applications.

Neuromuscular Electrical Stimulation (NMES) is a non-invasive method that activates intramuscular nerve branches and produces visible contractions through surface electrodes placed on skeletal muscles.

Aktiv komparator: superimposed NMES

Demographic and medical information of the patients (age, gender, height and body weight, occupation, educational status, CV, family history and surgical history, medical history related to knee osteoarthritis) and pain level will be questioned. In addition to conventional physiotherapy methods, superimposed NMES treatment will be applied in the group. Patients will be treated for one hour, three days a week, for eight weeks.

The physical functions, muscle structure and knee joint cartilage thickness, quality of life and functional status of the patients will be evaluated before and after treatment.

Conventional physiotherapy is a treatment method that includes exercise training, hotpack, ultrasound and TENS (electrotherapy) applications.

Superimposed NMES technique is the use of NMES with voluntary muscle contraction.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Muscle strength
Tidsramme: 8 weeks

The muscle strength of the participants will be evaluated with a hand dynamometer. Before the measurements, participants will be placed in a sitting position on the bed with hips and knees flexed at 90º, feet free, arms crossed over the chest and without support. For the test, the participant will be asked to do maximum knee extension and at the last point, resistance will be given to disrupt the position with a hand dynamometer. When the test position is disrupted, the score seen on the dynamometer screen will be recorded.

8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Joint position sense
Tidsramme: 8 weeks

The position sense of the knee joint will be evaluated with a digital inclinometer. Digital inclinometer is a motion-sensitive protractor. The test will be performed while the participants are in a prone position. Before the test, participants will be taught the target angle (20 degrees of flexion), and then they will be asked to reach this target angle again with their eyes closed. The amount of deviation from the target angle will be recorded as a score.

8 weeks
Muscle structure and knee joint cartilage thickness
Tidsramme: 8 weeks

Quadriceps muscle structure and knee joint cartilage structure will be evaluated with an ultrasonography device. Measurements will be taken from four sections of the quadriceps femoris muscle while the participants are at rest in the supine position. The measurement level will be determined as 50% of the femur length (the distance between the major trochanter and the lateral condyle). Muscle thicknesses will be determined by measuring the distance between the superficial and deep aponeurosis. The pennate angle will be calculated as the angle formed at the attachment point (insertion) of the muscle fascicles to the deep aponeurosis. Cartilage thickness will be measured at maximal knee flexion, in three regions: lateral, medial, and intercondylar.

8 weeks
Joint range of motion
Tidsramme: 8 weeks

Flexion and extension range of motion of the knee joint will be measured in degrees in the prone position using a goniometer. For measurement, the pivot point of the goniometer will be placed on the lateral condyle of the femur, its fixed arm will be placed on the lateral midline of the femur, and the movable arm of the goniometer will follow the fibula. The participant will be asked to actively bend and extend his knee and the final point value will be recorded as angle.

8 weeks
Short Form-36
Tidsramme: 8 weeks

Participants' quality of life will be evaluated with Short Form-36. This scale is a 36-item survey that questions the individual's quality of life, considering the last 4 weeks. It has eight sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health, emotional wellbeing

8 weeks
Western Ontario and McMaster Universities Osteoarthritis Index Scale
Tidsramme: 8 weeks

The functional status of the participants will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index Scale (WOMAC) scale. The scale, which consists of 24 questions, has 3 subsections: pain, stiffness and function. Higher scores indicate more severe symptoms, greater disability, and poorer health status.

8 weeks
Visual Analog Scale (VAS)
Tidsramme: 8 weeks

VAS is a horizontal line of 10 centimeters and the beginning of the line means no pain and the end of the line means unbearable pain. Participants will be asked to make a mark based on the pain they feel (9).

8 weeks
Balance assessment
Tidsramme: 8 weeks

Balance will be evaluated with the Balance Error Scoring System (BESS). This test is a short, easily administered static balance test. The test will be performed for 20 seconds in three different positions (double leg, single leg, tandem) on firm and foam surfaces. The number of balance deviations that occur in the participants during the test will be recorded as a score. High deviation score indicates more balance disorder.

8 weeks
Functional capacity
Tidsramme: 8 weeks

The 30-Second Chair Stand Test will be performed for functional capacity assessment. For this test, the participant will be seated in a chair without armrests and asked to sit and stand as much as possible for 30 seconds. The total number will be recorded

8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Mustafa Ertuğrul YAŞA, Saglik Bilimleri Universitesi
  • Studieleder: Emre Adıgüzel, Etlik City Hospital Physical Therapy and Rehabilitation Hospital
  • Ledende efterforsker: Oğuzhan METE, Saglik Bilimleri Universitesi

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. oktober 2023

Primær færdiggørelse (Faktiske)

31. marts 2025

Studieafslutning (Faktiske)

30. juni 2025

Datoer for studieregistrering

Først indsendt

19. februar 2024

Først indsendt, der opfyldte QC-kriterier

19. februar 2024

Først opslået (Faktiske)

26. februar 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2023-487

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