Knee OsteoarthritisNCT06277570
Investigation of the Effect of Superimposed Neuromuscular Electrical Stimulation in Patients With Knee Osteoarthritis.
A study testing conventional physiotherapy, NMES and Superimposed NMES in people with Knee Osteoarthritis, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the effects of superimposed neuromuscular electrical stimulation with active contraction on physical function, muscle and joint structure, functionality, and quality of life in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- conventional physiotherapy, NMES and Superimposed NMES
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Oct 2023to 30 Jun 2025
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having grade 2-3 knee osteoarthritis according to Kellgren and Lawrence Classification,
- Being between the ages of 40-65, ,
- Being literate
- Volunteer
Who cannot join
- Having Grade 2 or higher osteoarthritis in the hip, ankle, or foot joint Presence of a history of knee-related surgery (arthroplasty, meniscectomy, etc.)
- Having a deformity in the waist, leg, hip, knee, or ankle
- Having any inflammatory rheumatic, neurological, vestibular, cardiopulmonary disease
- Having active knee joint synovitis
- BMI>40
- Having a condition that is contraindicate for electrotherapy (malignancy, pacemaker, epilepsy, deep vein thrombosis, loss of protective sensation, etc.)
Show all 9Show fewer
- Having received physiotherapy in the last 3 months
- Being diagnosed with a psychiatric disease
- Having a cooperation problem that makes it difficult to comply with evaluation and treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Physiotherapy and Rehabilitation, University of Health Sciences
Ankara, Etlik, 06018
About this study
Official title: Investigation of the Effect of Superimposed Neuromuscular Electrical Stimulation With Active Contraction in Patients With Knee Osteoarthritis.
The aim of the study is to investigate the effects of superimposed neuromuscular electrical stimulation with active contraction on physical function, muscle and joint structure, functionality, and quality of life in patients with knee osteoarthritis.
Read the detailed description
Osteoarthritis (OA) is a progressive joint disease that can affect all structures that make up the joint, especially cartilage. The frequency of OA increases with age and can especially affect weight-bearing joints such as the knee and hip joints. The main symptoms of knee OA are pain, decreased joint range of motion (ROM), decreased muscle strength, functional loss, and limitation in daily living activities. However, studies conducted in individuals with knee OA report a decrease in quadriceps muscle and knee joint cartilage thickness and impairment in sensorimotor function (proprioception and balance).
Many pharmacological and non-pharmacological methods are used in symptom management of knee OA. In this context, physiotherapy and rehabilitation are among the frequently used non-pharmacological methods. Exercise, manual therapy, taping, aqua therapy, thermal therapy, and electrotherapy are the basic physiotherapy modalities used in OA symptom management. Electrotherapy involves many different agents with different therapeutic purposes. One of these is Neuromuscular Electrical Stimulation (NMES). NMES is a non-invasive method that activates intramuscular nerve branches through surface electrodes placed on skeletal muscles and produces observable contractions. Although its most important therapeutic purpose is muscle stimulation, it also has contributions such as pain relief and sensory stimulation. Superimposed NMES technique (active NMES) is the use of NMES with voluntary muscle contraction. In superimposed NMES with active contraction, the patient is asked to actively contract the relevant muscle during each stimulation. Thus, exercise is performed simultaneously during electrotherapy application. When the literature is examined, there is no study investigating the effect of superimposed NMES with active contraction in patients with knee OA. In this context, the aim of this study is to investigate the effect of superimposed NMES with active contraction on physical function, muscle and joint structure, functionality and quality of life in patients with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- conventional physiotherapy, NMES, Superimposed NMES
- Keywords
- Knee Osteoarthritis, Electric Stimulation Therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physiotherapyOther
Conventional physiotherapy is a treatment method that includes exercise training, hotpack, ultrasound and TENS (electrotherapy) applications.
NMESOther
Neuromuscular Electrical Stimulation (NMES) is a non-invasive method that activates intramuscular nerve branches and produces visible contractions through surface electrodes placed on skeletal muscles.
Superimposed NMESOther
Superimposed NMES technique is the use of NMES with voluntary muscle contraction.
| Study group | Role | What they receive |
|---|---|---|
| conventional physiotherapy | Active comparator | Demographic and medical information of the patients (age, gender, height and body weight, occupation, educational status, CV, family history and surgical history, medical history related to knee osteoarthritis) and pain level will be questioned. Conventional physiotherapy modalities will be applied in the group; exercise training, hotpack, ultrasound and transcutaneous electrical nerve stimulation (TENS). Patients will be treated for one hour, three days a week, for eight weeks.
The physical functions, muscle structure and knee joint cartilage thickness, quality of life and functional status of the patients will be evaluated before and after treatment. Receives: Other: conventional physiotherapy |
| NMES | Active comparator | Demographic and medical information of the patients (age, gender, height and body weight, occupation, educational status, CV, family history and surgical history, medical history related to knee osteoarthritis) and pain level will be questioned. In addition to conventional physiotherapy methods, passive NMES treatment will be applied in the group.Patients will be treated for one hour, three days a week, for eight weeks.
The physical functions, muscle structure and knee joint cartilage thickness, quality of life and functional status of the patients will be evaluated before and after treatment. Receives: Other: conventional physiotherapy; Other: NMES |
| superimposed NMES | Active comparator | Demographic and medical information of the patients (age, gender, height and body weight, occupation, educational status, CV, family history and surgical history, medical history related to knee osteoarthritis) and pain level will be questioned. In addition to conventional physiotherapy methods, superimposed NMES treatment will be applied in the group. Patients will be treated for one hour, three days a week, for eight weeks.
The physical functions, muscle structure and knee joint cartilage thickness, quality of life and functional status of the patients will be evaluated before and after treatment. Receives: Other: conventional physiotherapy; Other: Superimposed NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
The muscle strength of the participants will be evaluated with a hand dynamometer. Before the measurements, participants will be placed in a sitting position on the bed with hips and knees flexed at 90º, feet free, arms crossed over the chest and without support. For the test, the participant will be asked to do maximum knee extension and at the last point, resistance will be given to disrupt the position with a hand dynamometer. When the test position is disrupted, the score seen on the dynamometer screen will be recorded.
Measured: 8 weeks
Secondary outcomes (8)
Joint position sense
The position sense of the knee joint will be evaluated with a digital inclinometer. Digital inclinometer is a motion-sensitive protractor. The test will be performed while the participants are in a prone position. Before the test, participants will be taught the target angle (20 degrees of flexion), and then they will be asked to reach this target angle again with their eyes closed. The amount of deviation from the target angle will be recorded as a score.
Measured: 8 weeks
Muscle structure and knee joint cartilage thickness
Quadriceps muscle structure and knee joint cartilage structure will be evaluated with an ultrasonography device. Measurements will be taken from four sections of the quadriceps femoris muscle while the participants are at rest in the supine position. The measurement level will be determined as 50% of the femur length (the distance between the major trochanter and the lateral condyle). Muscle thicknesses will be determined by measuring the distance between the superficial and deep aponeurosis. The pennate angle will be calculated as the angle formed at the attachment point (insertion) of the muscle fascicles to the deep aponeurosis. Cartilage thickness will be measured at maximal knee flexion, in three regions: lateral, medial, and intercondylar.
Measured: 8 weeks
Joint range of motion
Flexion and extension range of motion of the knee joint will be measured in degrees in the prone position using a goniometer. For measurement, the pivot point of the goniometer will be placed on the lateral condyle of the femur, its fixed arm will be placed on the lateral midline of the femur, and the movable arm of the goniometer will follow the fibula. The participant will be asked to actively bend and extend his knee and the final point value will be recorded as angle.
Measured: 8 weeks
Short Form-36
Participants' quality of life will be evaluated with Short Form-36. This scale is a 36-item survey that questions the individual's quality of life, considering the last 4 weeks. It has eight sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health, emotional wellbeing
Measured: 8 weeks
Western Ontario and McMaster Universities Osteoarthritis Index Scale
The functional status of the participants will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index Scale (WOMAC) scale. The scale, which consists of 24 questions, has 3 subsections: pain, stiffness and function. Higher scores indicate more severe symptoms, greater disability, and poorer health status.
Measured: 8 weeks
Visual Analog Scale (VAS)
VAS is a horizontal line of 10 centimeters and the beginning of the line means no pain and the end of the line means unbearable pain. Participants will be asked to make a mark based on the pain they feel (9).
Measured: 8 weeks
Balance assessment
Balance will be evaluated with the Balance Error Scoring System (BESS). This test is a short, easily administered static balance test. The test will be performed for 20 seconds in three different positions (double leg, single leg, tandem) on firm and foam surfaces. The number of balance deviations that occur in the participants during the test will be recorded as a score. High deviation score indicates more balance disorder.
Measured: 8 weeks
Functional capacity
The 30-Second Chair Stand Test will be performed for functional capacity assessment. For this test, the participant will be seated in a chair without armrests and asked to sit and stand as much as possible for 30 seconds. The total number will be recorded
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start31 Oct 2023
- Primary completion31 Mar 2025
- Study completion30 Jun 2025
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample of the study will consist of participants who applied to Etlik City Physical Therapy and Rehabilitation Hospital, were diagnosed with knee osteoarthritis by the physician, and will receive routine treatment in the electrotherapy unit. Patients will be randomly assigned to groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ertuğrul Yaşa, Gulhane School of Medicine
- Investigators
- Mustafa Ertuğrul YAŞA, Principal investigator, Saglik Bilimleri UniversitesiEmre Adıgüzel, Study director, Etlik City Hospital Physical Therapy and Rehabilitation HospitalOğuzhan METE, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277570
- Sponsor's protocol ID
- 2023-487
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Superimposed Neuromuscular Electrical Stimulation With Active Contraction in Patients With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT06277570
- Acronym / sponsor ID
- 2023-487
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Electric Stimulation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 26 Feb 2024 (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 is to investigate the effects of superimposed neuromuscular electrical stimulation with active contraction on physical function, muscle and joint structure, functionality, and quality of life in patients with knee osteoarthritis.
Detailed description
Osteoarthritis (OA) is a progressive joint disease that can affect all structures that make up the joint, especially cartilage. The frequency of OA increases with age and can especially affect weight-bearing joints such as the knee and hip joints. The main symptoms of knee OA are pain, decreased joint range of motion (ROM), decreased muscle strength, functional loss, and limitation in daily living activities. However, studies conducted in individuals with knee OA report a decrease in quadriceps muscle and knee joint cartilage thickness and impairment in sensorimotor function (proprioception and balance).
Many pharmacological and non-pharmacological methods are used in symptom management of knee OA. In this context, physiotherapy and rehabilitation are among the frequently used non-pharmacological methods. Exercise, manual therapy, taping, aqua therapy, thermal therapy, and electrotherapy are the basic physiotherapy modalities used in OA symptom management. Electrotherapy involves many different agents with different therapeutic purposes. One of these is Neuromuscular Electrical Stimulation (NMES). NMES is a non-invasive method that activates intramuscular nerve branches through surface electrodes placed on skeletal muscles and produces observable contractions. Although its most important therapeutic purpose is muscle stimulation, it also has contributions such as pain relief and sensory stimulation. Superimposed NMES technique (active NMES) is the use of NMES with voluntary muscle contraction. In superimposed NMES with active contraction, the patient is asked to actively contract the relevant muscle during each stimulation. Thus, exercise is performed simultaneously during electrotherapy application. When the literature is examined, there is no study investigating the effect of superimposed NMES with active contraction in patients with knee OA. In this context, the aim of this study is to investigate the effect of superimposed NMES with active contraction on physical function, muscle and joint structure, functionality and quality of life in patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The sample of the study will consist of participants who applied to Etlik City Physical Therapy and Rehabilitation Hospital, were diagnosed with knee osteoarthritis by the physician, and will receive routine treatment in the electrotherapy unit. Patients will be randomly assigned to groups.
| Arm | Type | Receives |
|---|---|---|
| conventional physiotherapy | Active comparator | Other: conventional physiotherapyDemographic and medical information of the patients (age, gender, height and body weight, occupation, educational status, CV, family history and surgical history, medical history related to knee osteoarthritis) and pain level will be questioned. Conventional physiotherapy modalities will be applied in the group; exercise training, hotpack, ultrasound and transcutaneous electrical nerve stimulation (TENS). Patients will be treated for one hour, three days a week, for eight weeks. The physical functions, muscle structure and knee joint cartilage thickness, quality of life and functional status of the patients will be evaluated before and after treatment. |
| NMES | Active comparator | Other: conventional physiotherapy, Other: NMESDemographic and medical information of the patients (age, gender, height and body weight, occupation, educational status, CV, family history and surgical history, medical history related to knee osteoarthritis) and pain level will be questioned. In addition to conventional physiotherapy methods, passive NMES treatment will be applied in the group.Patients will be treated for one hour, three days a week, for eight weeks. The physical functions, muscle structure and knee joint cartilage thickness, quality of life and functional status of the patients will be evaluated before and after treatment. |
| superimposed NMES | Active comparator | Other: conventional physiotherapy, Other: Superimposed NMESDemographic and medical information of the patients (age, gender, height and body weight, occupation, educational status, CV, family history and surgical history, medical history related to knee osteoarthritis) and pain level will be questioned. In addition to conventional physiotherapy methods, superimposed NMES treatment will be applied in the group. Patients will be treated for one hour, three days a week, for eight weeks. The physical functions, muscle structure and knee joint cartilage thickness, quality of life and functional status of the patients will be evaluated before and after treatment. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having grade 2-3 knee osteoarthritis according to Kellgren and Lawrence Classification,
- Being between the ages of 40-65, ,
- Being literate
- Volunteer
Key exclusion criteria (9 listed)
- Having Grade 2 or higher osteoarthritis in the hip, ankle, or foot joint Presence of a history of knee-related surgery (arthroplasty, meniscectomy, etc.)
- Having a deformity in the waist, leg, hip, knee, or ankle
- Having any inflammatory rheumatic, neurological, vestibular, cardiopulmonary disease
- Having active knee joint synovitis
- BMI>40
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 |
|---|---|---|
| conventional physiotherapyConventional physiotherapy is a treatment method that includes exercise training, hotpack, ultrasound and TENS (electrotherapy) applications. | Other | NMES, conventional physiotherapy, superimposed NMES |
| NMESNeuromuscular Electrical Stimulation (NMES) is a non-invasive method that activates intramuscular nerve branches and produces visible contractions through surface electrodes placed on skeletal muscles. | Other | NMES |
| Superimposed NMESSuperimposed NMES technique is the use of NMES with voluntary muscle contraction. | Other | superimposed NMES |
Primary outcome
Muscle strength
Time frame: 8 weeks
The muscle strength of the participants will be evaluated with a hand dynamometer. Before the measurements, participants will be placed in a sitting position on the bed with hips and knees flexed at 90º, feet free, arms crossed over the chest and without support. For the test, the participant will be asked to do maximum knee extension and at the last point, resistance will be given to disrupt the position with a hand dynamometer. When the test position is disrupted, the score seen on the dynamometer screen will be recorded.
8 secondary outcomes
Joint position sense
Time frame: 8 weeks
Muscle structure and knee joint cartilage thickness
Time frame: 8 weeks
Joint range of motion
Time frame: 8 weeks
Short Form-36
Time frame: 8 weeks
Western Ontario and McMaster Universities Osteoarthritis Index Scale
Time frame: 8 weeks
Visual Analog Scale (VAS)
Time frame: 8 weeks
Balance assessment
Time frame: 8 weeks
Functional capacity
Time frame: 8 weeks
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 25 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.
Mustafa Ertuğrul YAŞA principal investigator
Saglik Bilimleri Universitesi
Emre Adıgüzel study director
Etlik City Hospital Physical Therapy and Rehabilitation Hospital
Oğuzhan METE principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional physiotherapy, NMES and Superimposed NMES in people with Knee Osteoarthritis, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
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 4 inclusion and 9 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Muscle strength (time frame: 8 weeks). 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 25 Sep 2026.