Exercise vs. Topical Diclofenac vs. PRP

Study Overview
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Brief Summary
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Osteoarthritis, the most common type of arthritis, is a chronic and degenerative joint disease. It has been reported to affect more than 300 million adults and elderly individuals worldwide. The joint most commonly affected by osteoarthritis is the knee joint and this condition is called gonarthrosis. The goal of treatment is to reduce symptoms and ultimately slow the progression of the disease with various treatment options throughout the course of the disease.Current clinical studies 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) According to the guidelines, treatment typically includes physiotherapy interventions with the use of non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics, including intra-articular injections of corticosteroids. Exercise-oriented physiotherapy is one of the main approaches for the conservative treatment of gonarthrosis. The curative clinical effect of exercise therapy on pain and functional disability in gonarthrosis is important. The use of PRP in the treatment of gonarthrosis is based on the ability of platelets to release biologically active proteins and promote tissue healing. Since the cartilage tissue mainly affected in gonarthrosis has low healing potential, this feature of platelets becomes more important for the target tissue. Existing studies show that PRP is superior to hyaluronic acid in intermediate and initial gonarthrosis; on the other hand, less satisfactory results are reported in severe gonarthrosis, similar to viscosupplementation. Topically or orally administered NSAIDs form the backbone of pharmacological treatment in gonarthrosis. It is seen that both exercise, PRP and topical NSAID agents are among the recommendations in the treatment of gonarthrosis. However, there is insufficient evidence regarding the superiority and therapeutic efficacy of these three treatment approaches. The aim of this study is to determine the effectiveness of exercise, PRP and NSAID-specific topical agents in the treatment of patients with gonarthrosis; pain, function, quality of life, and patient satisfaction.

Detailed Description
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Voluntary participants who have been diagnosed with gonarthritis 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) topical diclofenac, c) platalet-rich-plasma (PRP).

Official Title
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Comparison of Commonly Used Treatment Approaches in the Treatment of Gonarthrosis: Platelet-Rich Plasma, Topical Diclofenac, and Exercise

Conditions
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Gonarthrosis

Intervention / Treatment
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* Other: Exercise
* Other: Topical Diclofenac
* Other: Platelet-Rich-Plasma (PRP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with gonarthrosis according to the criteria of the American Society of Rheumatology (ACR) 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 barriers to being included in the exercise program Exclusion Criteria: Being in stage 4 according to Kellgren Lawrence radiological staging criteria, Hemoglobin level <11.5 g/dL Platelet level <100,000/μL Thrombocytopenia, coagulopathy, crystal arthropathy, hemophilia or hematological malignancy, Presence of active infection or tumor, Chronic antiaggregant use or taking immunosuppressive therapy, Pregnancy or lactation, Viscosupplementation or steroid injection in the related knee in the last 3 months, or using systemic steroids, 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 neurological diseases and/or deformity leading to lower extremity muscle weakness Having serious systemic and cardiovascular diseases that interfere with exercise

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group 1<br>The patients in the Exercise group will be treated with a structured exercise program. The exercises will be applied by the research physiotherapist for 6 weeks, 2 days a week. Each training session is planned to last approximately 30 minutes. | Other: Exercise<br>* The first 3 weeks of the exercise program will include range of motion exercises, isometric and isotonic strengthening exercises for the muscles around the knee and hip, and stretching exercises. In the following 3 weeks, resistance strengthening exercises and closed kinetic chain exercises will be added to the program.<br>|
| Active Comparator: Intervention Group 2<br>The patients in the topical agent group were prescribed by the orthopedist. they will use the topical agent. Diclofenac in gel form was chosen as a topical agent in the light of the literature. In this context, patients in both groups will apply the topical agent around the knee joint 4 days a week, 2 times a day (every 12 hours) in the morning and evening for 6 weeks. | Other: Topical Diclofenac<br>* They will apply it around the knee joint 4 days a week, 2 times a day (every 12 hours), morning and evening for 6 weeks.<br>|
| Active Comparator: Intervention Group 3<br>The PRP procedure with the same characteristics will be used in the treatment of patients in the PRP group. The PRP application will be prepared by the orthopedics and traumatology specialist physician in the research team, using the kits provided within the scope of the project. In order to collect venous blood for the PRP production procedure, gamma sterile vacuum tubes and blood collection set in special kits without the risk of contamination will be used. A total of 3 doses will be administered to the patients, with a one-week interval between doses. | Other: Platelet-Rich-Plasma (PRP)<br>* 8 ml of blood will be taken from each patient in tubes containing 0.9 ml of 3.2% sodium citrate. Swing-out rotor (open-swing type) will be placed in the centrifuge with the tubes facing each other. After centrifugation, 2.5 cc of PRP product will be collected from each tube and the resulting PRP will be administered to patients by injection under sterile conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. 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. | change from baseline pain at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 4 times for 24 weeks | 
| Health-Related Quality of Life Short Form-12 Scale (SF-12) | SF-12 is the abbreviated version of the Short Form-36 (SF-36) 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. | 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. | 4 times for 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physiotherapy, Non-steroidal anti-inflammatory drugs, Intraarticular Injection, Osteoarthrosis