Investigation of the Effect of Superimposed Neuromuscular Electrical Stimulation in Patients With Knee Osteoarthritis.

NCT ID: NCT06277570

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The sample of the study will consist of participants who applied to Etlik City Physical Therapy and Rehabilitation Hospital, were diagnosed with knee osteoarthritis by the physician, and will receive routine treatment in the electrotherapy unit. Patients will be randomly assigned to groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

conventional physiotherapy

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

conventional physiotherapy

Intervention Type OTHER

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

NMES

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

conventional physiotherapy

Intervention Type OTHER

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

Superimposed NMES

Intervention Type OTHER

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

Interventions

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conventional physiotherapy

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

Intervention Type OTHER

NMES

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.

Intervention Type OTHER

Superimposed NMES

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gulhane School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Mustafa Ertuğrul Yaşa

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mustafa Ertuğrul YAŞA

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Emre Adıgüzel

Role: STUDY_DIRECTOR

Etlik City Hospital Physical Therapy and Rehabilitation Hospital

Oğuzhan METE

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

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Faculty of Physiotherapy and Rehabilitation, University of Health Sciences

Ankara, Etlik, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Oğuzhan METE

Role: CONTACT

+90 5347409217

Emre ADIGÜZEL

Role: CONTACT

Facility Contacts

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Oğuzhan METE

Role: primary

Other Identifiers

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2023-487

Identifier Type: -

Identifier Source: org_study_id

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