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

NCT06277570 | Recruiting

• 1 other identifier: 2023-487
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Electric Stimulation Therapy

Outcome Measures

Primary Outcomes (1)

• Muscle strength

  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

Secondary Outcomes (8)

• Joint position sense

  8 weeks

• Muscle structure and knee joint cartilage thickness

  8 weeks

• Joint range of motion

  8 weeks

• Short Form-36

  8 weeks

• Western Ontario and McMaster Universities Osteoarthritis Index Scale

  8 weeks

Study Arms (3)

conventional physiotherapy

ACTIVE COMPARATOR

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.

Other: conventional physiotherapy

NMES

ACTIVE COMPARATOR

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.

Other: conventional physiotherapy; Other: NMES

superimposed NMES

ACTIVE COMPARATOR

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.

Other: conventional physiotherapy; Other: Superimposed NMES

Interventions

conventional physiotherapy OTHER

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

NMES; conventional physiotherapy; superimposed NMES

NMES 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.

NMES

Superimposed NMES OTHER

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

superimposed NMES

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Faculty of Physiotherapy and Rehabilitation, University of Health Sciences

Ankara, Etlik, 06018, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mustafa Ertuğrul YAŞA

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

• Emre Adıgüzel

  Etlik City Hospital Physical Therapy and Rehabilitation Hospital

  STUDY DIRECTOR

• Oğuzhan METE

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oğuzhan METE

CONTACT

+90 5347409217; oguzhan.mete@sbu.edu.tr

Emre ADIGÜZEL

CONTACT

dremreadiguzel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: October 31, 2023
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)