Osteo Arthritis KneeNCT05827003
Effects of Exercise Versus Topical Agents on Knee Osteoarthritis
A study testing Exercise, Exercise&Topical Agent and Topical Agent in people with Osteo Arthritis Knee, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis, a chronic and degenerative joint disease, is the most common type of arthritis and affects more than 300 million adults worldwide. Osteoarthritis, which is characterized by joint pain and stiffness, has negative consequences for function, participation and quality of life, which are important… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Exercise, Exercise&Topical Agent and Topical Agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 15 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with knee OA according to the criteria of the American Society of Rheumatology
- Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria
- Those between the ages of 40 and 65
- Body mass index below 30 kg/m2
- Pain intensity defined by the patient in the last 3 months is at least 3 out of 10 according to NPRS
- Patients who do not have any obstacles to be included in the exercise program
Who cannot join
- Using viscosupplementation or steroid injection or systemic steroids in the related knee in the last 3 months
- To have received a physiotherapy program for the relevant knee in the last 3 months
- Having a valgus or varus deformity greater than 15°
- Presence of active infection or tumor
- Presence of neurological diseases and/or deformity leading to lower extremity muscle weakness
- Having serious systemic and cardiovascular diseases that interfere with exercise
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Istanbul, 34500
About this study
Official title: The Comparison of the Effectiveness of Exercise and Topical Agent Treatments in Knee Osteoarthritis: A Randomized Controlled Trial
Osteoarthritis, a chronic and degenerative joint disease, is the most common type of arthritis and affects more than 300 million adults worldwide. Osteoarthritis, which is characterized by joint pain and stiffness, has negative consequences for function, participation and quality of life, which are important components of health. The knee joint is the most common joint in terms of osteoarthritis and is more common in individuals over 50 years of age.
There is no proven definitive treatment in today's literature for common osteoarthritis, which is one of the important causes of the global disease burden. However, since it is a progressive disease with varying degrees of severity, it is a chronic problem that requires long-term treatment. According to current clinical guidelines prepared by the working groups of the International Osteoarthritis Research Society (OARSI) and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases ESCEO , treatment typically includes physiotherapy interventions with the use of non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics, including intra-articular injections of corticosteroids; In more severe cases, joint replacement surgery is recommended.
The aim of this research project is to examine the effectiveness of a supervised exercise program applied in combination with NSAID-specific topical agents, in comparison with groups receiving only topical agents or only exercise treatments.
Read the detailed description
Voluntary participants who have been diagnosed with knee osteoarthritis will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into tree groups. Study groups will be as follows: a) exercise, b) exercise \& topical agent, c) topical agent.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Exercise, Exercise&Topical Agent, Topical Agent
- Keywords
- Diclofenac, Non-steroidal anti-inflammatory drugs, Physiotherapy, Gonarthrosis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Supervised exercise program with a physiotherapist for 6 weeks, two days a week
Exercise&Topical AgentOther
Diclofenac gel application to the knee joint twice a day, four days a week, in addition to a supervised exercise program under the supervision of a physiotherapist for 6 weeks.
Topical AgentOther
Application of diclofenac gel to the knee joint twice a day, four days a week, for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | Individuals with a diagnosis of knee osteoarthritis who underwent supervised exercise under the guidance of a physiotherapist for 6 weeks, 2 days a week. Receives: Other: Exercise |
| Exercise&Topical Agent | Active comparator | Individuals with a diagnosis of knee osteoarthritis who had supervised exercise under the guidance of a physiotherapist for 6 weeks, 2 days a week, and in addition to this program, they used diclofenac gel 2 times a day, 4 days a week. Receives: Other: Exercise; Other: Exercise&Topical Agent; Other: Topical Agent |
| Topical Agent | Active comparator | Individuals with a diagnosis of knee osteoarthritis using diclofenac gel twice a day, 4 days a week, for 6 weeks Receives: Other: Topical Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain via Numeric Pain Rating Scale
On this scale, "0" indicates the absence of pain, and "10" indicates the most severe pain imaginable (17). Patients will be asked to rate the severity of their knee pain with a number between 0 and 10 using this scale. The minimum clinically significant difference value (MCID) of this valid and reliable pain scale is 1.74 points.
Measured: change from baseline pain at 6 months
Secondary outcomes (6)
WOMAC
WOMAC assesses the level of difficulty, pain and joint stiffness experienced by the patients during their physical functions. WOMAC score is a 5-point Likert-type scale, high scores indicate poor status and consist of a total of 24 questions.
Measured: 4 times for 24 weeks
40 meters fast walking test
For 40mHYT, patients will be asked to walk as fast as possible on a flat and hard surface, on a 10-meter marked walking path. Walking time will be measured in seconds with a stopwatch. The test will be repeated three times and the arithmetic mean of these measurements will be recorded as the result value. Considering the age range of the patients, it was planned to allow a one-minute rest period between retests.
Measured: 4 times for 24 weeks
Stepping Test
Patients will be asked to climb 10 pre-marked 20 cm high steps as quickly as possible on a standard ladder. The test time will be measured in seconds with a stopwatch. The test will be repeated 3 times and the average value will be recorded in seconds. Similarly, in this evaluation, patients were given a one-minute rest period between 3 repetitions of the test.
Measured: 4 times for 24 weeks
Joint Range of Motion Evaluation
During the assessments, three repeat measurements will be made using an electronic goniometer. For goniometric measurement, the pivot point will be placed on the lateral condyle of the femur. The fixed arm will be held parallel to the lateral midline of the femur. The movable arm will follow the movement of the fibula.
Measured: 4 times for 24 weeks
Health-Related Quality of Life Short Form (SF-12) Scale
SF-12 is the abbreviated version of the SF36 Quality of Life Scale and is frequently preferred for ease of use. It has 2 components, physical and mental, scored between 0 and 50.
A high score from the score indicates health-related well-being and increased quality of life, while a decrease indicates worsening.
Measured: 4 times for 24 weeks
Global Rating of Change Scale-GRC
It will be used to evaluate patient satisfaction. It is designed to determine the amount of improvement or worsening of the patient over time.
In our study, GRC consisting of 5 levels between -2 and +2 value ranges (-2: I am much worse, -1: I am worse, 0: I am the same, 1: I am better, 2: I am much better) was preferred.
Measured: 3 times for 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start15 Apr 2024
- Primary completion15 Apr 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be an equal number of participants in the three groups randomized by the computer.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 79 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
- Investigators
- Derya Celik, Prof., Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827003
- Sponsor's protocol ID
- 83483935
- Status last verified
- Jan 2025
- First submitted
- 30 Mar 2023
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.
PubMed 31908163Safiri S, Kolahi AA, Smith E, Hill C, Bettampadi D, Mansournia MA, Hoy D, Ashrafi-Asgarabad A, Sepidarkish M, Almasi-Hashiani A, Collins G, Kaufman J, Qorbani M, Moradi-Lakeh M, Woolf AD, Guillemin F, March L, Cross M. Global, regional and national burden of osteoarthritis 1990-2017: a systematic analysis of the Global Burden of Disease Study 2017. Ann Rheum Dis. 2020 Jun;79(6):819-828. doi: 10.1136/annrheumdis-2019-216515. Epub 2020 May 12.
PubMed 32398285Loeser RF, Goldring SR, Scanzello CR, Goldring MB. Osteoarthritis: a disease of the joint as an organ. Arthritis Rheum. 2012 Jun;64(6):1697-707. doi: 10.1002/art.34453. Epub 2012 Mar 5. No abstract available.
PubMed 22392533Bruyere O, Honvo G, Veronese N, Arden NK, Branco J, Curtis EM, Al-Daghri NM, Herrero-Beaumont G, Martel-Pelletier J, Pelletier JP, Rannou F, Rizzoli R, Roth R, Uebelhart D, Cooper C, Reginster JY. An updated algorithm recommendation for the management of knee osteoarthritis from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). Semin Arthritis Rheum. 2019 Dec;49(3):337-350. doi: 10.1016/j.semarthrit.2019.04.008. Epub 2019 Apr 30.
PubMed 31126594Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.
PubMed 33560326Gregori D, Giacovelli G, Minto C, Barbetta B, Gualtieri F, Azzolina D, Vaghi P, Rovati LC. Association of Pharmacological Treatments With Long-term Pain Control in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. JAMA. 2018 Dec 25;320(24):2564-2579. doi: 10.1001/jama.2018.19319.
PubMed 30575881Arden NK, Perry TA, Bannuru RR, Bruyere O, Cooper C, Haugen IK, Hochberg MC, McAlindon TE, Mobasheri A, Reginster JY. Non-surgical management of knee osteoarthritis: comparison of ESCEO and OARSI 2019 guidelines. Nat Rev Rheumatol. 2021 Jan;17(1):59-66. doi: 10.1038/s41584-020-00523-9. Epub 2020 Oct 28.
PubMed 33116279van Doormaal MCM, Meerhoff GA, Vliet Vlieland TPM, Peter WF. A clinical practice guideline for physical therapy in patients with hip or knee osteoarthritis. Musculoskeletal Care. 2020 Dec;18(4):575-595. doi: 10.1002/msc.1492. Epub 2020 Jul 9.
PubMed 32643252Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
PubMed 31278997Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24.
PubMed 26405113Fernandes L, Hagen KB, Bijlsma JW, Andreassen O, Christensen P, Conaghan PG, Doherty M, Geenen R, Hammond A, Kjeken I, Lohmander LS, Lund H, Mallen CD, Nava T, Oliver S, Pavelka K, Pitsillidou I, da Silva JA, de la Torre J, Zanoli G, Vliet Vlieland TP; European League Against Rheumatism (EULAR). EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013 Jul;72(7):1125-35. doi: 10.1136/annrheumdis-2012-202745. Epub 2013 Apr 17.
PubMed 23595142
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Effectiveness of Exercise and Topical Agent Treatments in Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05827003
- Acronym / sponsor ID
- 83483935
- Conditions
- Osteo Arthritis Knee
- Keywords
- Diclofenac, Non-steroidal anti-inflammatory drugs, Physiotherapy, Gonarthrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 24 Apr 2023 (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.
Osteoarthritis, a chronic and degenerative joint disease, is the most common type of arthritis and affects more than 300 million adults worldwide. Osteoarthritis, which is characterized by joint pain and stiffness, has negative consequences for function, participation and quality of life, which are important components of health. The knee joint is the most common joint in terms of osteoarthritis and is more common in individuals over 50 years of age.
There is no proven definitive treatment in today's literature for common osteoarthritis, which is one of the important causes of the global disease burden. However, since it is a progressive disease with varying degrees of severity, it is a chronic problem that requires long-term treatment. According to current clinical guidelines prepared by the working groups of the International Osteoarthritis Research Society (OARSI) and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases ESCEO , treatment typically includes physiotherapy interventions with the use of non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics, including intra-articular injections of corticosteroids; In more severe cases, joint replacement surgery is recommended.
The aim of this research project is to examine the effectiveness of a supervised exercise program applied in combination with NSAID-specific topical agents, in comparison with groups receiving only topical agents or only exercise treatments.
Detailed description
Voluntary participants who have been diagnosed with knee osteoarthritis will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into tree groups. Study groups will be as follows: a) exercise, b) exercise \& topical agent, c) topical agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- There will be an equal number of participants in the three groups randomized by the computer.
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Other: ExerciseIndividuals with a diagnosis of knee osteoarthritis who underwent supervised exercise under the guidance of a physiotherapist for 6 weeks, 2 days a week. |
| Exercise&Topical Agent | Active comparator | Other: Exercise, Other: Exercise&Topical Agent, Other: Topical AgentIndividuals with a diagnosis of knee osteoarthritis who had supervised exercise under the guidance of a physiotherapist for 6 weeks, 2 days a week, and in addition to this program, they used diclofenac gel 2 times a day, 4 days a week. |
| Topical Agent | Active comparator | Other: Topical AgentIndividuals with a diagnosis of knee osteoarthritis using diclofenac gel twice a day, 4 days a week, for 6 weeks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with knee OA according to the criteria of the American Society of Rheumatology
- Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria
- Those between the ages of 40 and 65
- Body mass index below 30 kg/m2
- Pain intensity defined by the patient in the last 3 months is at least 3 out of 10 according to NPRS
Key exclusion criteria (6 listed)
- Using viscosupplementation or steroid injection or systemic steroids in the related knee in the last 3 months
- To have received a physiotherapy program for the relevant knee in the last 3 months
- Having a valgus or varus deformity greater than 15°
- Presence of active infection or tumor
- Presence of neurological diseases and/or deformity leading to lower extremity muscle weakness
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 |
|---|---|---|
| ExerciseSupervised exercise program with a physiotherapist for 6 weeks, two days a week | Other | Exercise, Exercise&Topical Agent |
| Exercise&Topical AgentDiclofenac gel application to the knee joint twice a day, four days a week, in addition to a supervised exercise program under the supervision of a physiotherapist for 6 weeks. | Other | Exercise&Topical Agent |
| Topical AgentApplication of diclofenac gel to the knee joint twice a day, four days a week, for 6 weeks | Other | Exercise&Topical Agent, Topical Agent |
Primary outcome
Change of Pain via Numeric Pain Rating Scale
Time frame: change from baseline pain at 6 months
On this scale, "0" indicates the absence of pain, and "10" indicates the most severe pain imaginable (17). Patients will be asked to rate the severity of their knee pain with a number between 0 and 10 using this scale. The minimum clinically significant difference value (MCID) of this valid and reliable pain scale is 1.74 points.
6 secondary outcomes
WOMAC
Time frame: 4 times for 24 weeks
40 meters fast walking test
Time frame: 4 times for 24 weeks
Stepping Test
Time frame: 4 times for 24 weeks
Joint Range of Motion Evaluation
Time frame: 4 times for 24 weeks
Health-Related Quality of Life Short Form (SF-12) Scale
Time frame: 4 times for 24 weeks
Global Rating of Change Scale-GRC
Time frame: 3 times for 24 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 4 Sep 2025.
- Background: PubMed 31908163Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.
- Background: PubMed 32398285Safiri S, Kolahi AA, Smith E, Hill C, Bettampadi D, Mansournia MA, Hoy D, Ashrafi-Asgarabad A, Sepidarkish M, Almasi-Hashiani A, Collins G, Kaufman J, Qorbani M, Moradi-Lakeh M, Woolf AD, Guillemin F, March L, Cross M. Global, regional and national burden of osteoarthritis 1990-2017: a systematic analysis of the Global Burden of Disease Study 2017. Ann Rheum Dis. 2020 Jun;79(6):819-828. doi: 10.1136/annrheumdis-2019-216515. Epub 2020 May 12.
- Background: PubMed 22392533Loeser RF, Goldring SR, Scanzello CR, Goldring MB. Osteoarthritis: a disease of the joint as an organ. Arthritis Rheum. 2012 Jun;64(6):1697-707. doi: 10.1002/art.34453. Epub 2012 Mar 5. No abstract available.
- Background: PubMed 31126594Bruyere O, Honvo G, Veronese N, Arden NK, Branco J, Curtis EM, Al-Daghri NM, Herrero-Beaumont G, Martel-Pelletier J, Pelletier JP, Rannou F, Rizzoli R, Roth R, Uebelhart D, Cooper C, Reginster JY. An updated algorithm recommendation for the management of knee osteoarthritis from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). Semin Arthritis Rheum. 2019 Dec;49(3):337-350. doi: 10.1016/j.semarthrit.2019.04.008. Epub 2019 Apr 30.
- Background: PubMed 33560326Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.
- Background: PubMed 30575881Gregori D, Giacovelli G, Minto C, Barbetta B, Gualtieri F, Azzolina D, Vaghi P, Rovati LC. Association of Pharmacological Treatments With Long-term Pain Control in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. JAMA. 2018 Dec 25;320(24):2564-2579. doi: 10.1001/jama.2018.19319.
- Background: PubMed 33116279Arden NK, Perry TA, Bannuru RR, Bruyere O, Cooper C, Haugen IK, Hochberg MC, McAlindon TE, Mobasheri A, Reginster JY. Non-surgical management of knee osteoarthritis: comparison of ESCEO and OARSI 2019 guidelines. Nat Rev Rheumatol. 2021 Jan;17(1):59-66. doi: 10.1038/s41584-020-00523-9. Epub 2020 Oct 28.
- Background: PubMed 32643252van Doormaal MCM, Meerhoff GA, Vliet Vlieland TPM, Peter WF. A clinical practice guideline for physical therapy in patients with hip or knee osteoarthritis. Musculoskeletal Care. 2020 Dec;18(4):575-595. doi: 10.1002/msc.1492. Epub 2020 Jul 9.
- Background: PubMed 31278997Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
- Background: PubMed 26405113Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24.
- Background: PubMed 23595142Fernandes L, Hagen KB, Bijlsma JW, Andreassen O, Christensen P, Conaghan PG, Doherty M, Geenen R, Hammond A, Kjeken I, Lohmander LS, Lund H, Mallen CD, Nava T, Oliver S, Pavelka K, Pitsillidou I, da Silva JA, de la Torre J, Zanoli G, Vliet Vlieland TP; European League Against Rheumatism (EULAR). EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013 Jul;72(7):1125-35. doi: 10.1136/annrheumdis-2012-202745. Epub 2013 Apr 17.
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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.
Derya Celik, Prof. study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Exercise&Topical Agent and Topical Agent in people with Osteo Arthritis Knee, run by Istanbul University - Cerrahpasa 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 6 inclusion and 6 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 4 Sep 2025. 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?
Change of Pain via Numeric Pain Rating Scale (time frame: change from baseline pain at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05827003, which also lists 11 linked publications.
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 4 Sep 2025.