Exercise vs. Topical Diclofenac vs. PRP

August 27, 2025 updated by: Sezen Karaborklu Argut, Istanbul University - Cerrahpasa

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34500
        • Istanbul University-Cerrahpaşa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Group 1
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
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.
Active Comparator: Intervention Group 2
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
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.
Active Comparator: Intervention Group 3
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. 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
Time Frame: 4 times for 24 weeks
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
Time Frame: 4 times for 24 weeks
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
Time Frame: 4 times for 24 weeks
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
Time Frame: 4 times for 24 weeks
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
Global Rating of Change Scale-GRC
Time Frame: 4 times for 24 weeks
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
Health-Related Quality of Life Short Form-12 Scale (SF-12)
Time Frame: 4 times for 24 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa

Investigators

  • Principal Investigator: Sezen Karabörklü Argut, PhD, Istanbul University - Cerrahpasa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2024

Primary Completion (Actual)

March 18, 2025

Study Completion (Actual)

May 18, 2025

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4370438302

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe