Knee OsteoarthritisOANCT06270329
Neuromuscular Training Program in Patients With Knee OA (Osteoarthritis)
A study testing Neuromuscular training program and conventional physical therapy program in people with Knee Osteoarthritis, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the effects of neuromuscular training program and conventional physical therapy program on pain, functional status, physical performance, balance, muscle strength and quality of life in patients with knee osteoarthritis (KOA). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Neuromuscular training program and conventional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2022to 15 Jun 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having grade 2 or 3 osteoarthritis according to the Kellgren and Lawrence Classification
- Having pain score of 2 or above on VAS
- Not having received physical therapy in the last 3 months
- Not having received an intra-articular corticosteroid injection in the last 6 months
- Not having used oral corticosteroids in the last month
- Being between the ages of 40-80
- Body mass index being between 19-40 kg/cm2
Who cannot join
- Systemic arthritis
- Hypertensive condition that prevents exercise
- Pregnancy, cognitive impairment, parkinson-like neurological disorders
- Having had a knee or hip joint replacement
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Science University
Kütahya, 43100
About this study
Official title: Comparison of the Effectiveness of Neuromuscular Training Program and Conventional Physical Therapy Program in Patients With Knee Osteoarthritis.
The aim of this study was to compare the effects of neuromuscular training program and conventional physical therapy program on pain, functional status, physical performance, balance, muscle strength and quality of life in patients with knee osteoarthritis (KOA).
Read the detailed description
The study was carried out in Afyonkarahisar Health Sciences University Health Application Research Center in individuals with 2nd or 3rd degree KOA according to Kellgren and Lawrence Classification. The study was planned as a randomized controlled clinical trial design. The study group were recruited to the neuromuscular training program and the control group were recruited to the conventional physical therapy program 5 days a week for 3 weeks. Individuals were evaluated at the baseline and after training programs. Demographic and clinical data were first recorded in the evaluation.
- Conditions
- Knee Osteoarthritis
- Being tested
- Neuromuscular training program, conventional physical therapy program
- Keywords
- Neuromuscular training, Knee osteoarthritis, Physical 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.
Neuromuscular training programOther
Hotpack application TENS (transcutaneous electrical stimulation) Warm-up phase: bicycle ergometer (ten minutes)
Exercise phase:
core stabilization and postural control exercises postural orientation exercises lower extremity strengthening exercises functional exercises (balance and proprioception exercises using a balance board) Cool-down Phase
conventional physical therapy programOther
Hotpack application TENS (transcutaneous electrical stimulation) Conventional physical therapy exercises (straight leg raises, knee flexor and extensor strengthening, hip muscle strengthening)
| Study group | Role | What they receive |
|---|---|---|
| neuromuscular training program | Experimental | Participants were administered the neuromuscular training program 60 min a day, 2 days a week for 8 weeks. Receives: Other: Neuromuscular training program |
| conventional physical therapy program | Active comparator | Participants were administered the conventional physiotherapy program 60 min a day, 2 days a week for 8 weeks. Receives: Other: conventional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Pain evaluation. The participant is asked to give a score between 1 and 10 for her pain.
Measured: At first and third week
Western Ontario and McMasterUniversities Osteoarhritis Index
Functional status evaluation. The scale consists of 3 subheadings that evaluate pain, stiffness and physical function.
High Western Ontario and McMasterUniversities Osteoarhritis Index score indicates increased pain and stiffness and deterioration in physical function.
Measured: At first and third week
Time on One Leg Standing
Balance evaluation. Participants were asked to stand on one leg with their eyes open for as long as possible, and the time was measured with a stopwatch and recorded in seconds.
Measured: At first and third week
Five Times Sit to Stand Test
Physical performance evaluation. The time it takes for the patient to sit and stand up from a chair five times is recorded. As time decreases, it indicates better performance.
Measured: At first and third week
Manual Muscle Test
Muscle strength evaluation. A score between 0 and 5 is given depending on muscle strength.
Measured: At first and third week
Short Form
Quality of life evaluation. It consists of 8 subheadings: physical function, problems caused by physical problems, emotional well-being, problems caused by emotional problems, general health, social function, pain, energy/fatigue.
High scores indicate good health, low scores indicate poor health.
Measured: At first and third week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start15 Jan 2022
- Primary completion15 Jan 2023
- Study completion15 Jun 2023
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 Kutahya Health Sciences 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled clinical trial design
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Ozge OKUR, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270329
- Sponsor's protocol ID
- NMTwithKOA
- Acronym
- OA
- Status last verified
- Feb 2024
- First submitted
- 10 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Neuromuscular Training Program and Conventional Physical Therapy Program in Patients With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT06270329
- Acronym / sponsor ID
- OA / NMTwithKOA
- Conditions
- Knee Osteoarthritis
- Keywords
- Neuromuscular training, Knee osteoarthritis, Physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 21 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 this study was to compare the effects of neuromuscular training program and conventional physical therapy program on pain, functional status, physical performance, balance, muscle strength and quality of life in patients with knee osteoarthritis (KOA).
Detailed description
The study was carried out in Afyonkarahisar Health Sciences University Health Application Research Center in individuals with 2nd or 3rd degree KOA according to Kellgren and Lawrence Classification. The study was planned as a randomized controlled clinical trial design. The study group were recruited to the neuromuscular training program and the control group were recruited to the conventional physical therapy program 5 days a week for 3 weeks. Individuals were evaluated at the baseline and after training programs. Demographic and clinical data were first recorded in the evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled clinical trial design
| Arm | Type | Receives |
|---|---|---|
| neuromuscular training program | Experimental | Other: Neuromuscular training programParticipants were administered the neuromuscular training program 60 min a day, 2 days a week for 8 weeks. |
| conventional physical therapy program | Active comparator | Other: conventional physical therapy programParticipants were administered the conventional physiotherapy program 60 min a day, 2 days a week for 8 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Having grade 2 or 3 osteoarthritis according to the Kellgren and Lawrence Classification
- Having pain score of 2 or above on VAS
- Not having received physical therapy in the last 3 months
- Not having received an intra-articular corticosteroid injection in the last 6 months
- Not having used oral corticosteroids in the last month
Key exclusion criteria (4 listed)
- Systemic arthritis
- Hypertensive condition that prevents exercise
- Pregnancy, cognitive impairment, parkinson-like neurological disorders
- Having had a knee or hip joint replacement
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 training programHotpack application TENS (transcutaneous electrical stimulation) Warm-up phase: bicycle ergometer (ten minutes) Exercise phase: core stabilization and postural control exercises postural orientation exercises lower extremity strengthening exercises functional exercises (balance and proprioception exercises using a balance board) Cool-down Phase | Other | neuromuscular training program |
| conventional physical therapy programHotpack application TENS (transcutaneous electrical stimulation) Conventional physical therapy exercises (straight leg raises, knee flexor and extensor strengthening, hip muscle strengthening) | Other | conventional physical therapy program |
Primary outcome
Visual Analog Scale
Time frame: At first and third week
Pain evaluation. The participant is asked to give a score between 1 and 10 for her pain.
Western Ontario and McMasterUniversities Osteoarhritis Index
Time frame: At first and third week
Functional status evaluation. The scale consists of 3 subheadings that evaluate pain, stiffness and physical function. High Western Ontario and McMasterUniversities Osteoarhritis Index score indicates increased pain and stiffness and deterioration in physical function.
Time on One Leg Standing
Time frame: At first and third week
Balance evaluation. Participants were asked to stand on one leg with their eyes open for as long as possible, and the time was measured with a stopwatch and recorded in seconds.
Five Times Sit to Stand Test
Time frame: At first and third week
Physical performance evaluation. The time it takes for the patient to sit and stand up from a chair five times is recorded. As time decreases, it indicates better performance.
Manual Muscle Test
Time frame: At first and third week
Muscle strength evaluation. A score between 0 and 5 is given depending on muscle strength.
Short Form
Time frame: At first and third week
Quality of life evaluation. It consists of 8 subheadings: physical function, problems caused by physical problems, emotional well-being, problems caused by emotional problems, general health, social function, pain, energy/fatigue. High scores indicate good health, low scores indicate poor health.
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 21 Feb 2024.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Knee Osteoarthritis
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
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Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
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RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular training program and conventional physical therapy program in people with Knee Osteoarthritis, run by Kutahya Health Sciences University 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 7 inclusion and 4 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 21 Feb 2024. 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?
Visual Analog Scale (time frame: At first and third week). The study lists 6 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 21 Feb 2024.