Effects of Exercise Versus Topical Agents on Knee Osteoarthritis

NCT05827003 | Completed

• 1 other identifier: 83483935
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Keywords

Diclofenac; Non-steroidal anti-inflammatory drugs; Physiotherapy; Gonarthrosis

Outcome Measures

Primary Outcomes (1)

• Change of Pain via Numeric Pain Rating Scale

  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 Outcomes (6)

• WOMAC

  4 times for 24 weeks

• 40 meters fast walking test

  4 times for 24 weeks

• Stepping Test

  4 times for 24 weeks

• Joint Range of Motion Evaluation

  4 times for 24 weeks

• Health-Related Quality of Life Short Form (SF-12) Scale

  4 times for 24 weeks

Study Arms (3)

Exercise

ACTIVE COMPARATOR

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

Exercise&Topical Agent

ACTIVE COMPARATOR

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

Topical Agent

ACTIVE COMPARATOR

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

Other: Topical Agent

Interventions

Exercise OTHER

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

Exercise; Exercise&Topical Agent

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.

Exercise&Topical Agent

Topical Agent OTHER

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

Exercise&Topical Agent; Topical Agent

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (11)

• Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.

  PMID: 31908163 BACKGROUND

• Safiri S, Kolahi AA, Smith E, Hill C, Bettampadi D, Mansournia MA, Hoy D, Ashrafi-Asgarabad A, Sepidarkish M, Almasi-Hashiani A, Collins G, Kaufman J, Qorbani M, Moradi-Lakeh M, Woolf AD, Guillemin F, March L, Cross M. Global, regional and national burden of osteoarthritis 1990-2017: a systematic analysis of the Global Burden of Disease Study 2017. Ann Rheum Dis. 2020 Jun;79(6):819-828. doi: 10.1136/annrheumdis-2019-216515. Epub 2020 May 12.

  PMID: 32398285 BACKGROUND

• Loeser RF, Goldring SR, Scanzello CR, Goldring MB. Osteoarthritis: a disease of the joint as an organ. Arthritis Rheum. 2012 Jun;64(6):1697-707. doi: 10.1002/art.34453. Epub 2012 Mar 5. No abstract available.

  PMID: 22392533 BACKGROUND

• Bruyere O, Honvo G, Veronese N, Arden NK, Branco J, Curtis EM, Al-Daghri NM, Herrero-Beaumont G, Martel-Pelletier J, Pelletier JP, Rannou F, Rizzoli R, Roth R, Uebelhart D, Cooper C, Reginster JY. An updated algorithm recommendation for the management of knee osteoarthritis from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). Semin Arthritis Rheum. 2019 Dec;49(3):337-350. doi: 10.1016/j.semarthrit.2019.04.008. Epub 2019 Apr 30.

  PMID: 31126594 BACKGROUND

• Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.

  PMID: 33560326 BACKGROUND

• Gregori D, Giacovelli G, Minto C, Barbetta B, Gualtieri F, Azzolina D, Vaghi P, Rovati LC. Association of Pharmacological Treatments With Long-term Pain Control in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. JAMA. 2018 Dec 25;320(24):2564-2579. doi: 10.1001/jama.2018.19319.

  PMID: 30575881 BACKGROUND

• Arden NK, Perry TA, Bannuru RR, Bruyere O, Cooper C, Haugen IK, Hochberg MC, McAlindon TE, Mobasheri A, Reginster JY. Non-surgical management of knee osteoarthritis: comparison of ESCEO and OARSI 2019 guidelines. Nat Rev Rheumatol. 2021 Jan;17(1):59-66. doi: 10.1038/s41584-020-00523-9. Epub 2020 Oct 28.

  PMID: 33116279 BACKGROUND

• van Doormaal MCM, Meerhoff GA, Vliet Vlieland TPM, Peter WF. A clinical practice guideline for physical therapy in patients with hip or knee osteoarthritis. Musculoskeletal Care. 2020 Dec;18(4):575-595. doi: 10.1002/msc.1492. Epub 2020 Jul 9.

  PMID: 32643252 BACKGROUND

• Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.

  PMID: 31278997 BACKGROUND

• Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24.

  PMID: 26405113 BACKGROUND

• Fernandes L, Hagen KB, Bijlsma JW, Andreassen O, Christensen P, Conaghan PG, Doherty M, Geenen R, Hammond A, Kjeken I, Lohmander LS, Lund H, Mallen CD, Nava T, Oliver S, Pavelka K, Pitsillidou I, da Silva JA, de la Torre J, Zanoli G, Vliet Vlieland TP; European League Against Rheumatism (EULAR). EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013 Jul;72(7):1125-35. doi: 10.1136/annrheumdis-2012-202745. Epub 2013 Apr 17.

  PMID: 23595142 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Derya Celik, Prof.

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The assessor will not know which participant received which intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There will be an equal number of participants in the three groups randomized by the computer.

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 24, 2023
• Study Start: April 15, 2024
• Primary Completion: April 15, 2025
• Study Completion: June 15, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-01

Locations

TU (1)