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临床试验/NCT03571698
NCT03571698已完成不适用

Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation

Istanbul University0 个研究点目标入组 60 人开始时间: 2016年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Visual Analoque Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
47 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Exercise programme only

No Intervention

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.

Exercise with NMES standard electrodes

Active Comparator

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.

干预措施: Neuromuscular Electrical Stimulator (Device)

Exercise with NMES large electrodes

Active Comparator

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.

干预措施: Neuromuscular Electrical Stimulator (Device)

结局指标

主要结局

Visual Analoque Scale

时间窗: The rest, night time and pain in activity were assessed by VAS before treatment versus after 6 weeks of treatment.

Pain intensity was assessed using the VAS; each patient was asked the pain during the rest, activity, and at night time.

Knee Extensor Muscle Strength

时间窗: Quadriceps Femoris Muscle strength was measured before treatment versus after 6 weeks of treatment.

Quadriceps Femoris Muscle strength was measured using a Hand-held Dynomometer.

次要结局

  • Stair Climbimg Test (SCT)(Balance was assessed by SCT before treatment versus after 6 weeks of treatment.)
  • One Leg Standing Test(Balance was assessed by One Leg Standing Test before treatment versus after 6 weeks of treatment.)
  • Knee Range of Motion(Knee Flexion and extension were taken using Digital Goniometer before treatment versus after 6 weeks treatent.)
  • Global Rating Change Scales(Satisfactions was assessed using by Global Rating Change Scales before treatment versus after 6 weeks of treatment.)
  • WOMAC (Western Ontario and McMaster Universities Index)(Pain, stiffness and physical function were assessed by WOMAC before treatment versus after 6 weeks of treatment.)
  • Muscle Strength using a Hand-held Dynomometer(Hip flexor, extensor, adductor, abductor groups muscles, knee flexor groups muscles strength were measaured before treatment versus after 6 weeks of treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ekin Aktay

Physical Therapist Master in Science

Istanbul University

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