Knee OsteoarthritisNCT04697667
Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis
A study testing Exercise and PRP in people with Knee Osteoarthritis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study is a prospective randomized controlled study of different treatments for knee osteoarthritis and aims to investigate the efficacy of exercise combined platelet rich plasma (PRP) injection versus only exercise or only PRP treatments. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercise and PRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2021to 10 Feb 2022
- 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 40-70 years of age,
- Grade 2-3 according to Kellgren Lawrence osteoarthritis classification,
- No medication for knee osteoarthritis in the past three months,
- Subjects who understand and sign the consent form for this study.
Who cannot join
- Patients who have received an invasive procedure, intra-articular application and / or physiotherapy in the target knee within three months,
- Previous partial or total knee replacement of the target knee,
- Body mass index > 30 kg/m2,
- Having any cardiovascular diseases, neurological disorders, rheumatic diseases, malignancy or psychiatric diseases,
- Impaired cognition that impacts the ability to give informed consent,
- Participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Combination of Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial
This study is a prospective randomized controlled study of different treatments for knee osteoarthritis and aims to investigate the efficacy of exercise combined platelet rich plasma (PRP) injection versus only exercise or only PRP treatments.
- Conditions
- Knee Osteoarthritis
- Being tested
- Exercise, PRP
- 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
PRPBiological
Intra-articular PRP injections to knee joint
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Each subject in this group will receive a combined treatment protocol consisting of three PRP injections to knee joint and supervised exercise program. Receives: Other: Exercise; Biological: PRP |
| Group II | Active comparator | Each subject in this group will receive a treatment of supervised exercise program. Receives: Other: Exercise |
| Group III | Active comparator | Each subject in this group will receive a treatment of three PRP injections to knee joint. Receives: Biological: PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be measured using the numerical pain rating scale. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Measured: 6th week
Pain intensity
Pain intensity will be measured using the numerical pain rating scale. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Measured: 3rd month
Function
Functional status of the patients will be evaluated by The Western Ontario and McMaster Universities Arthritis (WOMAC) Index. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness and Physical Function). 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). Higher scores on the WOMAC indicate worse results.
Measured: 6th week
Functional performance - 40m fast-paced walk test
Functional performance of the patients will be evaluated by 40-meter fast-paced walk test. Participants are asked to walk as quickly but as safely as possible, without running, along a 10-meter walkway for a total distance of 40 meters. Walking speed will be measured in meters/second (m/s).
Measured: 6th week
Functional performance - 10-step stair-climb test
Functional performance of the patients will be evaluated by 10-step stair-climb test. Patients are instructed to ascend and descend the flight of stairs as quickly as possible but in a safe manner. The time needed is recorded in seconds.
Measured: 6th week
Function
Functional status of the patients will be evaluated by The Western Ontario and McMaster Universities Arthritis (WOMAC) Index. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness and Physical Function). 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). Higher scores on the WOMAC indicate worse results.
Measured: 3rd month
Functional performance - 40m fast-paced walk test
Functional performance of the patients will be evaluated by 40-meter fast-paced walk test. Participants are asked to walk as quickly but as safely as possible, without running, along a 10-meter walkway for a total distance of 40 meters. Walking speed will be measured in meters/second (m/s).
Measured: 3rd month
Functional performance - 10-step stair-climb test
Functional performance of the patients will be evaluated by 10-step stair-climb test. Patients are instructed to ascend and descend the flight of stairs as quickly as possible but in a safe manner. The time needed is recorded in seconds.
Measured: 3rd month
Secondary outcomes (6)
Range of motion
Knee joint ROMs will be measured using a universal goniometer. The process will be repeated three times and the average value will be recorded.
Measured: 6th week
Range of motion
Knee joint ROMs will be measured using a universal goniometer. The process will be repeated three times and the average value will be recorded.
Measured: 3rd month
Health related quality of life
Health related quality of life will be measured using SF 12 score that measures eight health domains to assess physical and mental health.
Measured: 6th week
Health related quality of life
Health related quality of life will be measured using SF 12 score that measures eight health domains to assess physical and mental health.
Measured: 3rd month
Patient Satisfaction
Patient satisfaction will be assessed by the Global Rating of Change scale.
Measured: 6th week
Patient Satisfaction
Patient satisfaction will be assessed by the Global Rating of Change scale.
Measured: 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start31 Jan 2021
- Primary completion7 Jan 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 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
- NCT04697667
- Sponsor's protocol ID
- TDK-2020-35062
- Status last verified
- Feb 2026
- First submitted
- 3 Jan 2021
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karaborklu Argut S, Celik D, Ergin ON, Kilicoglu OI. Does the Combination of Platelet-rich Plasma and Supervised Exercise Yield Better Pain Relief and Enhanced Function in Knee Osteoarthritis? A Randomized Controlled Trial. Clin Orthop Relat Res. 2024 Jun 1;482(6):1051-1061. doi: 10.1097/CORR.0000000000002993. Epub 2024 Feb 6.
PubMed 38323999
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04697667
- Acronym / sponsor ID
- TDK-2020-35062
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 6 Jan 2021 (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.
This study is a prospective randomized controlled study of different treatments for knee osteoarthritis and aims to investigate the efficacy of exercise combined platelet rich plasma (PRP) injection versus only exercise or only PRP treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Exercise, Biological: PRPEach subject in this group will receive a combined treatment protocol consisting of three PRP injections to knee joint and supervised exercise program. |
| Group II | Active comparator | Other: ExerciseEach subject in this group will receive a treatment of supervised exercise program. |
| Group III | Active comparator | Biological: PRPEach subject in this group will receive a treatment of three PRP injections to knee joint. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 40-70 years of age,
- Grade 2-3 according to Kellgren Lawrence osteoarthritis classification,
- No medication for knee osteoarthritis in the past three months,
- Subjects who understand and sign the consent form for this study.
Key exclusion criteria (6 listed)
- Patients who have received an invasive procedure, intra-articular application and / or physiotherapy in the target knee within three months,
- Previous partial or total knee replacement of the target knee,
- Body mass index > 30 kg/m2,
- Having any cardiovascular diseases, neurological disorders, rheumatic diseases, malignancy or psychiatric diseases,
- Impaired cognition that impacts the ability to give informed consent,
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 | Other | Group I, Group II |
| PRPIntra-articular PRP injections to knee joint | Biological | Group I, Group III |
Primary outcome
Pain intensity
Time frame: 6th week
Pain intensity will be measured using the numerical pain rating scale. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Pain intensity
Time frame: 3rd month
Pain intensity will be measured using the numerical pain rating scale. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Function
Time frame: 6th week
Functional status of the patients will be evaluated by The Western Ontario and McMaster Universities Arthritis (WOMAC) Index. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness and Physical Function). 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). Higher scores on the WOMAC indicate worse results.
Functional performance - 40m fast-paced walk test
Time frame: 6th week
Functional performance of the patients will be evaluated by 40-meter fast-paced walk test. Participants are asked to walk as quickly but as safely as possible, without running, along a 10-meter walkway for a total distance of 40 meters. Walking speed will be measured in meters/second (m/s).
Functional performance - 10-step stair-climb test
Time frame: 6th week
Functional performance of the patients will be evaluated by 10-step stair-climb test. Patients are instructed to ascend and descend the flight of stairs as quickly as possible but in a safe manner. The time needed is recorded in seconds.
Function
Time frame: 3rd month
Functional status of the patients will be evaluated by The Western Ontario and McMaster Universities Arthritis (WOMAC) Index. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness and Physical Function). 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). Higher scores on the WOMAC indicate worse results.
Functional performance - 40m fast-paced walk test
Time frame: 3rd month
Functional performance of the patients will be evaluated by 40-meter fast-paced walk test. Participants are asked to walk as quickly but as safely as possible, without running, along a 10-meter walkway for a total distance of 40 meters. Walking speed will be measured in meters/second (m/s).
Functional performance - 10-step stair-climb test
Time frame: 3rd month
Functional performance of the patients will be evaluated by 10-step stair-climb test. Patients are instructed to ascend and descend the flight of stairs as quickly as possible but in a safe manner. The time needed is recorded in seconds.
6 secondary outcomes
Range of motion
Time frame: 6th week
Range of motion
Time frame: 3rd month
Health related quality of life
Time frame: 6th week
Health related quality of life
Time frame: 3rd month
Patient Satisfaction
Time frame: 6th week
Patient Satisfaction
Time frame: 3rd month
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 2 Mar 2026.
- Results publication: PubMed 38323999Karaborklu Argut S, Celik D, Ergin ON, Kilicoglu OI. Does the Combination of Platelet-rich Plasma and Supervised Exercise Yield Better Pain Relief and Enhanced Function in Knee Osteoarthritis? A Randomized Controlled Trial. Clin Orthop Relat Res. 2024 Jun 1;482(6):1051-1061. doi: 10.1097/CORR.0000000000002993. Epub 2024 Feb 6.
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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 Exercise and PRP in people with Knee Osteoarthritis, 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 4 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 2 Mar 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?
Pain intensity (time frame: 6th week). The study lists 8 primary outcomes in all. 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 NCT04697667, which also lists 1 linked publication.
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 2 Mar 2026.