Clinical trial NCT03571698: The Efficacy of Exercise and Alternative Applications of NMES on Pain and Function in Patients With Knee OA
Official title: Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Neuromuscular Electrical Stimulation
Exercise
Pain
Function
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 47
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Visual Analoque Scale
timeFrame: The rest, night time and pain in activity were assessed by VAS before treatment versus after 6 weeks of treatment.
measure: Knee Extensor Muscle Strength
timeFrame: Quadriceps Femoris Muscle strength was measured before treatment versus after 6 weeks of treatment.
Secondary outcomes:
measure: Knee Range of Motion
timeFrame: Knee Flexion and extension were measured with Digital Goniometer on sitting position before treatment versus after 6 weeks.
measure: Knee Range of Motion
timeFrame: Knee Flexion and extension were taken using Digital Goniometer before treatment versus after 6 weeks treatent.
measure: Muscle Strength using a Hand-held Dynomometer
timeFrame: Hip flexor, extensor, adductor, abductor groups muscles, knee flexor groups muscles strength were measaured before treatment versus after 6 weeks of treatment.
measure: WOMAC (Western Ontario and McMaster Universities Index)
timeFrame: Pain, stiffness and physical function were assessed by WOMAC before treatment versus after 6 weeks of treatment.
measure: Stair Climbimg Test (SCT)
timeFrame: Balance was assessed by SCT before treatment versus after 6 weeks of treatment.
measure: One Leg Standing Test
timeFrame: Balance was assessed by One Leg Standing Test before treatment versus after 6 weeks of treatment.
measure: Global Rating Change Scales
timeFrame: Satisfactions was assessed using by Global Rating Change Scales before treatment versus after 6 weeks of treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University
name: Yıldız Analay Akbaba, Assist Prof.
role: STUDY_DIRECTOR
affiliation: Istanbul University
name: Ekin Aktay, MSc
role: PRINCIPAL_INVESTIGATOR
References: