Clinical trial NCT06277570: Investigation of the Effect of Superimposed Neuromuscular Electrical Stimulation in Patients With Knee Osteoarthritis.
Official title: Investigation of the Effect of Superimposed Neuromuscular Electrical Stimulation With Active Contraction in Patients With Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Electric Stimulation Therapy
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 63
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Muscle strength
timeFrame: 8 weeks
Secondary outcomes:
measure: Joint position sense
timeFrame: 8 weeks
measure: Muscle structure and knee joint cartilage thickness
timeFrame: 8 weeks
measure: Joint range of motion
timeFrame: 8 weeks
measure: Short Form-36
timeFrame: 8 weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Index Scale
timeFrame: 8 weeks
measure: Visual Analog Scale (VAS)
timeFrame: 8 weeks
measure: Balance assessment
timeFrame: 8 weeks
measure: Functional capacity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Faculty of Physiotherapy and Rehabilitation, University of Health Sciences
state: Etlik
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Mustafa Ertuğrul YAŞA
role: PRINCIPAL_INVESTIGATOR
affiliation: Etlik City Hospital Physical Therapy and Rehabilitation Hospital
name: Emre Adıgüzel
role: STUDY_DIRECTOR
affiliation: Saglik Bilimleri Universitesi
name: Oğuzhan METE
role: PRINCIPAL_INVESTIGATOR
References: