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Effects of Exercise Versus Topical Agents on Knee Osteoarthritis

I

Istanbul University - Cerrahpasa

Status

Completed

Conditions

Osteo Arthritis Knee

Treatments

Other: Exercise&Topical Agent
Other: Exercise
Other: Topical Agent

Study type

Interventional

Funder types

Other

Identifiers

NCT05827003
83483935

Details and patient eligibility

About

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.

Full 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.

Enrollment

79 patients

Sex

All

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

79 participants in 3 patient groups

Exercise
Active Comparator group
Description:
Individuals with a diagnosis of knee osteoarthritis who underwent supervised exercise under the guidance of a physiotherapist for 6 weeks, 2 days a week.
Treatment:
Other: Exercise
Exercise&Topical Agent
Active Comparator group
Description:
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.
Treatment:
Other: Topical Agent
Other: Exercise
Other: Exercise&Topical Agent
Topical Agent
Active Comparator group
Description:
Individuals with a diagnosis of knee osteoarthritis using diclofenac gel twice a day, 4 days a week, for 6 weeks
Treatment:
Other: Topical Agent

Trial contacts and locations

1

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Central trial contact

Sezen Karaborklu Argut, PhD; Aysenur Erekdag, PhD (c)

Data sourced from clinicaltrials.gov

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