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NCT Number: NCT05827003

Effects of Exercise Versus Topical Agents on Knee Osteoarthritis

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.

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Key information

Conditions

Osteo Arthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Istanbul, 34500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

Supervised exercise program with a physiotherapist for 6 weeks, two days a week

Exercise&Topical Agent

Other

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.

Topical Agent

Other

Application of diclofenac gel to the knee joint twice a day, four days a week, for 6 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2023
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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