Knee OsteoarthritisNCT03571698
The Efficacy of Exercise and Alternative Applications of NMES on Pain and Function in Patients With Knee OA
A study testing Neuromuscular Electrical Stimulator in people with Knee Osteoarthritis, run by Istanbul University.
Trial 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. Read more about this study
- Who is it for?
- Ages 47 to 74 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Neuromuscular Electrical Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2016to 2 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 47 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
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.
Read the 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
- Being tested
- Neuromuscular Electrical Stimulator
- Keywords
- Knee Osteoarthritis, Neuromuscular Electrical Stimulation, Exercise, Pain, Function
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical StimulatorDevice
The treatment group received exercise programme with simultaneously active contraction with NMES with large or standart electrodes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Neuromuscular Electrical Stimulator |
| 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. Receives: Device: Neuromuscular Electrical Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analoque Scale
Pain intensity was assessed using the VAS; each patient was asked the pain during the rest, activity, and at night time.
Measured: The rest, night time and pain in activity were assessed by VAS before treatment versus after 6 weeks of treatment.
Knee Extensor Muscle Strength
Quadriceps Femoris Muscle strength was measured using a Hand-held Dynomometer.
Measured: Quadriceps Femoris Muscle strength was measured before treatment versus after 6 weeks of treatment.
Secondary outcomes (7)
Knee Range of Motion
Knee Flexion and extension were measured using a Digital Goniometer.
Measured: Knee Flexion and extension were measured with Digital Goniometer on sitting position before treatment versus after 6 weeks.
Knee Range of Motion
Knee Flexion and extension were taken using a Digital Goniometer on sitting position.
Measured: Knee Flexion and extension were taken using Digital Goniometer before treatment versus after 6 weeks treatent.
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.
Measured: Hip flexor, extensor, adductor, abductor groups muscles, knee flexor groups muscles strength were measaured before treatment versus after 6 weeks of treatment.
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.
Measured: Pain, stiffness and physical function were assessed by WOMAC before treatment versus after 6 weeks of treatment.
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.
Measured: Balance was assessed by SCT before treatment versus after 6 weeks of treatment.
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.
Measured: Balance was assessed by One Leg Standing Test before treatment versus after 6 weeks of treatment.
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.
Measured: Satisfactions was assessed using by Global Rating Change Scales before treatment versus after 6 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start15 Oct 2016
- Primary completion2 Aug 2017
- Study completion2 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekin Aktay, Istanbul University
- Investigators
- Yıldız Analay Akbaba, Assist Prof., Study director, Istanbul UniversityEkin Aktay, MSc, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571698
- Sponsor's protocol ID
- IstU
- Status last verified
- Jun 2018
- First submitted
- 30 May 2018
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
- ClinicalTrials.gov ID
- NCT03571698
- Acronym / sponsor ID
- IstU
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Neuromuscular Electrical Stimulation, Exercise, Pain, Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Oct 2016 (actual)
- Primary completion
- 2 Aug 2017 (actual)
- Study completion
- 2 Aug 2017 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Neuromuscular Electrical StimulatorThe 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. |
| Exercise with NMES large electrodes | Active comparator | Device: Neuromuscular Electrical StimulatorThe 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. |
Who may qualify
- Ages
- 47 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Electrical StimulatorThe treatment group received exercise programme with simultaneously active contraction with NMES with large or standart electrodes. | Device | Exercise with NMES large electrodes, Exercise with NMES standard electrodes |
Primary outcome
Visual Analoque Scale
Time frame: 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
Time frame: 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.
7 secondary outcomes
Knee Range of Motion
Time frame: Knee Flexion and extension were measured with Digital Goniometer on sitting position before treatment versus after 6 weeks.
Knee Range of Motion
Time frame: Knee Flexion and extension were taken using Digital Goniometer before treatment versus after 6 weeks treatent.
Muscle Strength 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.
WOMAC (Western Ontario and McMaster Universities Index)
Time frame: Pain, stiffness and physical function were assessed by WOMAC before treatment versus after 6 weeks of treatment.
Stair Climbimg Test (SCT)
Time frame: Balance was assessed by SCT before treatment versus after 6 weeks of treatment.
One Leg Standing Test
Time frame: Balance was assessed by One Leg Standing Test before treatment versus after 6 weeks of treatment.
Global Rating Change Scales
Time frame: Satisfactions was assessed using by Global Rating Change Scales before treatment versus after 6 weeks of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yıldız Analay Akbaba, Assist Prof. study director
Istanbul University
Ekin Aktay, MSc principal investigator
Istanbul University
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulator in people with Knee Osteoarthritis, run by Istanbul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analoque Scale (time frame: The rest, night time and pain in activity were assessed by VAS before treatment versus after 6 weeks of treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.