Knee OsteoarthritisNCT07212647
Home-Based Strategies for Knee Osteoarthritis
A study testing Home Exercise Group and Topical Therapy Group in people with Knee Osteoarthritis and Knee Osteoarthritis (Knee OA), run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial summary
Knee osteoarthritis (KOA) is a common chronic joint condition leading to pain, functional limitations, and reduced quality of life. This randomized controlled trial aims to evaluate and compare the effectiveness of a structured home-based exercise program versus topical diclofenac sodium therapy in improving pain… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
- What is being tested?
- Home Exercise Group and Topical Therapy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 9 Oct 2025to 26 Feb 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40-70 years
- Diagnosed with Kellgren-Lawrence grade I-II knee osteoarthritis
- Ability to provide written informed consent
Who cannot join
- Advanced KOA (Kellgren-Lawrence grade IV) requiring arthroplasty
- Prior knee surgery within the past year
- Intra-articular injections within the last 3 months
- Neurological, rheumatological, or systemic conditions affecting mobility
- Inability to comply with study procedures
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul University-Cerrahpaşa Faculty of Health Science
Istanbul, Buyukcekmece, 34500
Sezen Karaborklu Argut
Istanbul, 34295
About this study
Official title: Home-Based Strategies for Knee Osteoarthritis: Comparative Effectiveness of Exercise and Topical Therapy in a Randomized Controlled Trial
Knee osteoarthritis (KOA) is a common chronic joint condition leading to pain, functional limitations, and reduced quality of life. This randomized controlled trial aims to evaluate and compare the effectiveness of a structured home-based exercise program versus topical diclofenac sodium therapy in improving pain, functional outcomes, and health-related quality of life among adults with early-stage KOA. The results are intended to provide evidence on the optimal components of home-based conservative management strategies.
- Conditions
- Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
- Being tested
- Home Exercise Group, Topical Therapy Group
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Exercise GroupOther
Patient education + structured, video-based home exercise program Participants instructed to perform exercises 5 days per week for 6 weeks Adherence monitored via logs and telephone follow-up at week 3
Topical Therapy GroupOther
Patient education + 1.5% diclofenac sodium gel Participants applied gel to anterior, medial, and lateral aspects of the knee, once daily, without massage techniques, for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise Group | Experimental | Each subject in the home exercise group will receive a video-based protocol of exercises for knee osteoarthritis to perform at home. Receives: Other: Home Exercise Group |
| Topical Therapy Group | Active comparator | Each subject in the topical therapy group will apply topical gel to anterior, medial, and lateral aspects of the knee at home. Receives: Other: Topical Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
Pain intensity will be measured using an 11-point numeric pain rating scale, with 0 indicating no pain and 10 indicating the worst pain conceivable. Patients will be asked to rate their knee pain's severity with a number between 0 and 10 using this scale. The minimum clinically important difference (MCID) of this validated pain scale is accepted as >2.
Measured: Baseline
Numeric Pain Rating Scale (NPRS)
Pain intensity will be measured using an 11-point numeric pain rating scale, with 0 indicating no pain and 10 indicating the worst pain conceivable. Patients will be asked to rate their knee pain's severity with a number between 0 and 10 using this scale. The minimum clinically important difference (MCID) of this validated pain scale is accepted as >2.
Measured: Six-week
Secondary outcomes (4)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The assessment of functional difficulty will be measured the WOMAC index. The total score of the WOMAC ranges from 0 to 100 (lower scores representing lower level of disability), and the MCID was reported as 12 points.
Measured: Baseline
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The assessment of functional difficulty will be measured the WOMAC index. The total score of the WOMAC ranges from 0 to 100 (lower scores representing lower level of disability), and the MCID was reported as 12 points.
Measured: Six-week
12-Item Short Form Survey (SF-12)
The assessment of health-related quality of life will be measured the 12-Item Short Form Survey (SF-12). The SF-12 physical and mental scores (range 0 to 100, representing worst to best; MCID of 5) was used to evaluate health-related quality of life
Measured: Baseline
12-Item Short Form Survey (SF-12)
The assessment of health-related quality of life will be measured the 12-Item Short Form Survey (SF-12). The SF-12 physical and mental scores (range 0 to 100, representing worst to best; MCID of 5) was used to evaluate health-related quality of life
Measured: Six- week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start9 Oct 2025
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
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 University - CerrahpasaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sezen Karaborklu Argut, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212647
- Sponsor's protocol ID
- 132409382161
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Strategies for Knee Osteoarthritis: Comparative Effectiveness of Exercise and Topical Therapy in a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07212647
- Acronym / sponsor ID
- 132409382161
- Conditions
- Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 8 Oct 2025 (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.
Knee osteoarthritis (KOA) is a common chronic joint condition leading to pain, functional limitations, and reduced quality of life. This randomized controlled trial aims to evaluate and compare the effectiveness of a structured home-based exercise program versus topical diclofenac sodium therapy in improving pain, functional outcomes, and health-related quality of life among adults with early-stage KOA. The results are intended to provide evidence on the optimal components of home-based conservative management strategies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Home Exercise Group | Experimental | Other: Home Exercise GroupEach subject in the home exercise group will receive a video-based protocol of exercises for knee osteoarthritis to perform at home. |
| Topical Therapy Group | Active comparator | Other: Topical Therapy GroupEach subject in the topical therapy group will apply topical gel to anterior, medial, and lateral aspects of the knee at home. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 40-70 years
- Diagnosed with Kellgren-Lawrence grade I-II knee osteoarthritis
- Ability to provide written informed consent
Key exclusion criteria (5 listed)
- Advanced KOA (Kellgren-Lawrence grade IV) requiring arthroplasty
- Prior knee surgery within the past year
- Intra-articular injections within the last 3 months
- Neurological, rheumatological, or systemic conditions affecting mobility
- Inability to comply with study procedures
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 |
|---|---|---|
| Home Exercise GroupPatient education + structured, video-based home exercise program Participants instructed to perform exercises 5 days per week for 6 weeks Adherence monitored via logs and telephone follow-up at week 3 | Other | Home Exercise Group |
| Topical Therapy GroupPatient education + 1.5% diclofenac sodium gel Participants applied gel to anterior, medial, and lateral aspects of the knee, once daily, without massage techniques, for 6 weeks | Other | Topical Therapy Group |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline
Pain intensity will be measured using an 11-point numeric pain rating scale, with 0 indicating no pain and 10 indicating the worst pain conceivable. Patients will be asked to rate their knee pain's severity with a number between 0 and 10 using this scale. The minimum clinically important difference (MCID) of this validated pain scale is accepted as >2.
Numeric Pain Rating Scale (NPRS)
Time frame: Six-week
Pain intensity will be measured using an 11-point numeric pain rating scale, with 0 indicating no pain and 10 indicating the worst pain conceivable. Patients will be asked to rate their knee pain's severity with a number between 0 and 10 using this scale. The minimum clinically important difference (MCID) of this validated pain scale is accepted as >2.
4 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Six-week
12-Item Short Form Survey (SF-12)
Time frame: Baseline
12-Item Short Form Survey (SF-12)
Time frame: Six- week
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 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Exercise Group and Topical Therapy Group in people with Knee Osteoarthritis and Knee Osteoarthritis (Knee OA), run by Istanbul University - Cerrahpasa at 2 sites 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 3 inclusion and 5 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 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Numeric Pain Rating Scale (NPRS) (time frame: Baseline). 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 Feb 2026.