Effects of Exercise Versus Topical Agents on Knee Osteoarthritis

NCT ID: NCT05827003

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2025-06-15

Brief Summary

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.

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.

Conditions

Osteo Arthritis Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

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

Exercise&Topical Agent

Intervention Type: 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

Intervention Type: OTHER

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

Topical Agent

Individuals with a diagnosis of knee osteoarthritis using diclofenac gel twice a day, 4 days a week, for 6 weeks

Group Type: ACTIVE_COMPARATOR

Topical Agent

Intervention Type: OTHER

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

Interventions

Exercise

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

Intervention Type: 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.

Intervention Type: OTHER

Topical Agent

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Sezen Karaborklu Argut

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derya Celik, Prof.

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

Istanbul University-Cerrahpasa

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Other Identifiers

83483935

Identifier Type: -

Identifier Source: org_study_id