Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Exercise; Biological: PRP

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Istanbul University-Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Each subject in this group will receive a combined treatment protocol consisting of three PRP injections to knee joint and supervised exercise program.	Other: Exercise; Supervised exercise program; Biological: PRP; Intra-articular PRP injections to knee joint
Active Comparator: Group II; Each subject in this group will receive a treatment of supervised exercise program.	Other: Exercise; Supervised exercise program
Active Comparator: Group III; Each subject in this group will receive a treatment of three PRP injections to knee joint.	Biological: PRP; Intra-articular PRP injections to knee joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	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'.	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.	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).	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.	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.	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).	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.	3rd month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	3rd month
Patient Satisfaction	Patient satisfaction will be assessed by the Global Rating of Change scale.	6th week
Patient Satisfaction	Patient satisfaction will be assessed by the Global Rating of Change scale.	3rd month

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2021
• Primary Completion (Actual): January 7, 2022
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: January 3, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: TDK-2020-35062

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No