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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulator
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Neuromuscular Electrical Stimulation, Exercise, Pain, Function

Eligibility Criteria

47 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Active Comparator

    Arm Label

    Exercise programme only

    Exercise with NMES standard electrodes

    Exercise with NMES large electrodes

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Knee Range of Motion
    Knee Flexion and extension were measured using a Digital Goniometer.
    Knee Range of Motion
    Knee Flexion and extension were taken using a Digital Goniometer on sitting position.
    Muscle Strength using a Hand-held Dynomometer
    Hip flexor, extensor, adductor, abductor groups muscles, knee flexor groups muscles strength were measaured using a Hand-held Dynomometer.
    WOMAC (Western Ontario and McMaster Universities Index)
    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:[1] Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.
    Stair Climbimg Test (SCT)
    The SCT assesses the ability to ascend and descend a flight of stairs, as well as lower extremity balance.Test included the number of steps, the task requirement (ascent only or ascent/decent combined), or whether the test is timed over a set number of steps or the step count is recorded for a set period of time: 9-step ascend/descend, 4-step ascend/descend (6),3-step ascent cycle duration, 30-second test (12 steps), 3-step measured on 0 - 6 scale of level of assistance., and 6-step fast and self-paced.
    One Leg Standing Test
    One single-leg standing was assessed balance. Test required the subject to stand with arms by his/her side.Timing was started when the subject raised one foot off the ground. Timing was stopped if the subject displaced the weight-bearing foot, touched the suspended foot to the ground, used the suspended limb to support the weight-bearing limb, or reached the maximum balance time of 30 seconds.
    Global Rating Change Scales
    Rating levels of satisfaction is critical to a successful survey. Global Rating Scale's levels of satisfaction may vary from "Not at all satisfied" to "Very Satisfied" or "Extremely Satisfied," but the scale is not balanced in the same way as Performance or Expectation.

    Full Information

    First Posted
    May 30, 2018
    Last Updated
    June 18, 2018
    Sponsor
    Istanbul University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03571698
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 15, 2016 (Actual)
    Primary Completion Date
    August 2, 2017 (Actual)
    Study Completion Date
    August 2, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    Knee Osteoarthritis, Neuromuscular Electrical Stimulation, Exercise, Pain, Function

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise programme only
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Exercise with NMES standard electrodes
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Exercise with NMES large electrodes
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Neuromuscular Electrical Stimulator
    Intervention Description
    The treatment group received exercise programme with simultaneously active contraction with NMES with large or standart electrodes.
    Primary Outcome Measure Information:
    Title
    Visual Analoque Scale
    Description
    Pain intensity was assessed using the VAS; each patient was asked the pain during the rest, activity, and at night time.
    Time Frame
    The rest, night time and pain in activity were assessed by VAS before treatment versus after 6 weeks of treatment.
    Title
    Knee Extensor Muscle Strength
    Description
    Quadriceps Femoris Muscle strength was measured using a Hand-held Dynomometer.
    Time Frame
    Quadriceps Femoris Muscle strength was measured before treatment versus after 6 weeks of treatment.
    Secondary Outcome Measure Information:
    Title
    Knee Range of Motion
    Description
    Knee Flexion and extension were measured using a Digital Goniometer.
    Time Frame
    Knee Flexion and extension were measured with Digital Goniometer on sitting position before treatment versus after 6 weeks.
    Title
    Knee Range of Motion
    Description
    Knee Flexion and extension were taken using a Digital Goniometer on sitting position.
    Time Frame
    Knee Flexion and extension were taken using Digital Goniometer before treatment versus after 6 weeks treatent.
    Title
    Muscle Strength using a Hand-held Dynomometer
    Description
    Hip flexor, extensor, adductor, abductor groups muscles, knee flexor groups muscles strength were measaured using a Hand-held Dynomometer.
    Time Frame
    Hip flexor, extensor, adductor, abductor groups muscles, knee flexor groups muscles strength were measaured before treatment versus after 6 weeks of treatment.
    Title
    WOMAC (Western Ontario and McMaster Universities Index)
    Description
    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:[1] Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.
    Time Frame
    Pain, stiffness and physical function were assessed by WOMAC before treatment versus after 6 weeks of treatment.
    Title
    Stair Climbimg Test (SCT)
    Description
    The SCT assesses the ability to ascend and descend a flight of stairs, as well as lower extremity balance.Test included the number of steps, the task requirement (ascent only or ascent/decent combined), or whether the test is timed over a set number of steps or the step count is recorded for a set period of time: 9-step ascend/descend, 4-step ascend/descend (6),3-step ascent cycle duration, 30-second test (12 steps), 3-step measured on 0 - 6 scale of level of assistance., and 6-step fast and self-paced.
    Time Frame
    Balance was assessed by SCT before treatment versus after 6 weeks of treatment.
    Title
    One Leg Standing Test
    Description
    One single-leg standing was assessed balance. Test required the subject to stand with arms by his/her side.Timing was started when the subject raised one foot off the ground. Timing was stopped if the subject displaced the weight-bearing foot, touched the suspended foot to the ground, used the suspended limb to support the weight-bearing limb, or reached the maximum balance time of 30 seconds.
    Time Frame
    Balance was assessed by One Leg Standing Test before treatment versus after 6 weeks of treatment.
    Title
    Global Rating Change Scales
    Description
    Rating levels of satisfaction is critical to a successful survey. Global Rating Scale's levels of satisfaction may vary from "Not at all satisfied" to "Very Satisfied" or "Extremely Satisfied," but the scale is not balanced in the same way as Performance or Expectation.
    Time Frame
    Satisfactions was assessed using by Global Rating Change Scales before treatment versus after 6 weeks of treatment.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    47 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yıldız Analay Akbaba, Assist Prof.
    Organizational Affiliation
    Istanbul University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ekin Aktay, MSc
    Organizational Affiliation
    Istanbul University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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