Effects of Exercise Versus Topical Agents on Knee Osteoarthritis

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

The Comparison of the Effectiveness of Exercise and Topical Agent Treatments in Knee Osteoarthritis: A Randomized Controlled Trial

Osteoarthritis, a chronic and degenerative joint disease, is the most common type of arthritis and affects more than 300 million adults worldwide. Osteoarthritis, which is characterized by joint pain and stiffness, has negative consequences for function, participation and quality of life, which are important components of health. The knee joint is the most common joint in terms of osteoarthritis and is more common in individuals over 50 years of age.

There is no proven definitive treatment in today's literature for common osteoarthritis, which is one of the important causes of the global disease burden. However, since it is a progressive disease with varying degrees of severity, it is a chronic problem that requires long-term treatment. According to current clinical guidelines 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 , treatment typically includes physiotherapy interventions with the use of non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics, including intra-articular injections of corticosteroids; In more severe cases, joint replacement surgery is recommended.

The aim of this research project is to examine the effectiveness of a supervised exercise program applied in combination with NSAID-specific topical agents, in comparison with groups receiving only topical agents or only exercise treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Voluntary participants who have been diagnosed with knee osteoarthritis 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) exercise & topical agent, c) topical agent.

Study Type

Interventional

Enrollment (Actual)

79

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-Cerrahpasa

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

Yes

Description

Inclusion Criteria:

  • Diagnosed with knee OA according to the criteria of the American Society of Rheumatology
  • 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 obstacles to be included in the exercise program

Exclusion Criteria:

  • Using viscosupplementation or steroid injection or systemic steroids in the related knee in the last 3 months
  • 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 active infection or tumor
  • 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: Exercise
Individuals with a diagnosis of knee osteoarthritis who underwent supervised exercise under the guidance of a physiotherapist for 6 weeks, 2 days a week.
Other: Exercise
Supervised exercise program with a physiotherapist for 6 weeks, two days a week
Active Comparator: Exercise&Topical Agent
Individuals with a diagnosis of knee osteoarthritis who had supervised exercise under the guidance of a physiotherapist for 6 weeks, 2 days a week, and in addition to this program, they used diclofenac gel 2 times a day, 4 days a week.
Other: Exercise
Supervised exercise program with a physiotherapist for 6 weeks, two days a week
Other: Exercise&Topical Agent
Diclofenac gel application to the knee joint twice a day, four days a week, in addition to a supervised exercise program under the supervision of a physiotherapist for 6 weeks.
Other: Topical Agent
Application of diclofenac gel to the knee joint twice a day, four days a week, for 6 weeks
Active Comparator: Topical Agent
Individuals with a diagnosis of knee osteoarthritis using diclofenac gel twice a day, 4 days a week, for 6 weeks
Other: Topical Agent
Application of diclofenac gel to the knee joint twice a day, four days a week, for 6 weeks

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 (17). 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: 3 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.
3 times for 24 weeks
Health-Related Quality of Life Short Form (SF-12) Scale
Time Frame: 4 times for 24 weeks

SF-12 is the abbreviated version of the SF36 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

  • Study Director: Derya Celik, Prof., 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)

April 15, 2024

Primary Completion (Actual)

April 15, 2025

Study Completion (Actual)

June 15, 2025

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

April 21, 2023

First Posted (Actual)

April 24, 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

  • 83483935

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.

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