The Efficacy of Exercise and Alternative Applications of NMES on Pain and Function in Patients With Knee OA

NCT ID: NCT03571698

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-15
• Study Completion Date: 2017-08-02

Brief Summary

The aim of the study was to investigate the efficacy of exercise and different size electrodes of neuromuscular electrical stimulation (NMES) applications on pain, range of motion (ROM), muscle strength, function status and depression in knee osteoarthritis.

60 voluntary patients were included in the study and these patients divided into three groups randomly. For Group 1 only exercise, for Group 2 simultaneously active contraction with NMES with standard size electrodes, for Group 3 simultaneously active contraction with NMES with large electrodes applied for 3 days per week, 18 session. Pain was measured with Visual analog Scale (VAS), ROM was measured with digital goniometer, muscle strength was measured with "Hand-held" dynamometer (Lafayette Instrument®, Lafayette, IN), functional status were measured with WOMAC (Western Ontario and McMaster Universities) Index and stair climbing test, balance was analysed with one leg standing test, depression was scored with Hospital Anxiety Depression Scale and patients satisfaction was scored with Global Rating Change Scales. The cases evaluated before and after treatment.

Detailed Description

Aim: This study investigated the effect of neuromuscular electrical stimulation (NMES) was applied with different size electrodes on the functionality, pain, range of motion (ROM), and muscle strength in patients wtih knee osteoarthritis (OA).

Material and Metod: Sixty patients with knee OA who received physical therapy for knee pain and functional disability at Istanbul University, Faculty of Health Sciences, Division of Physiotherapy were included. These patients divided into three groups randomly. Group 1 applied exercise programme. Group 2 performed exercise programme with NMES with standard size electrodes (5×5 cm²). Group 3 performed exercise programme with NMES with large size electrodes (10×20 cm², 3×18 cm², 10 3×7.5 cm², 7×14 cm²) NMES was applied for 20 minutes to Group 2 and Group 3. The patients attended 18 treatment sessions 3 times per week in the physical therapy clinic and underwent assesment before treatment and after 6 weeks of treatment. Pain was measured with Visual Analog Scale (VAS), range of motion (ROM) was measured with digital goniometer, muscle strength was measured with ''Hand-held'' dynomometer, functional status were measured with WOMAC (Western Ontario and McMaster Universities) Index and stair climbing test, balance was analysed with one leg standing test. Patients satisfaction was scored with Global Change Scales.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Exercise programme only

The treatment group received only exercise programme. The exercises was done by a physical therapist in clinical center. The treatment group received exercise programme with simultaneously active contraction with NMES with large electrodes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise with NMES standard electrodes

The treatment group received exercise programme with simultaneously active contraction with NMES with standard electrodes.The exercises was done by a physical therapist in clinical center. The treatment group received exercise programme with simultaneously active contraction with NMES with large electrodes.

Group Type: ACTIVE_COMPARATOR

Neuromuscular Electrical Stimulator

Intervention Type: DEVICE

The treatment group received exercise programme with simultaneously active contraction with NMES with large or standart electrodes.

Exercise with NMES large electrodes

The treatment group received exercise programme with simultaneously active contraction with NMES with large electrodes.The exercises was done by a physical therapist in clinical center. The treatment group received exercise programme with simultaneously active contraction with NMES with large electrodes.

Group Type: ACTIVE_COMPARATOR

Neuromuscular Electrical Stimulator

Intervention Type: DEVICE

The treatment group received exercise programme with simultaneously active contraction with NMES with large or standart electrodes.

Interventions

Neuromuscular Electrical Stimulator

The treatment group received exercise programme with simultaneously active contraction with NMES with large or standart electrodes.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Acceppting to participate Being between 45-74 years according to the description of the World Health Organisation Being women Having Osteoarthritis on right knee. Having the symptoms of Grade 2-3 according to Kellgren ve Lawrence Classification Having a value below 30 according to Body Mass Index

Exclusion Criteria

Not accepting to partipate Having left knee Osteoarthritis Having an orthopedic problem on lower extremity Having uncontrollable hypertension Having arteriovenous problem on lower extremity Having confusion about regular participation Having a neurogical problem Having learning and perception problem Having heart implant Being included in physiotherapy and rehabilitation program for knee OA in last 6 month Having injection application for knee in last 6 month

• Minimum Eligible Age: 47 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Ekin Aktay

Physical Therapist Master in Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yıldız Analay Akbaba, Assist Prof.

Role: STUDY_DIRECTOR

Istanbul University

Ekin Aktay, MSc

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Other Identifiers

IstU

Identifier Type: -

Identifier Source: org_study_id