Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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The Combination of Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Exercise
* Biological: PRP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |