Exercise vs. Topical Diclofenac vs. PRP

NCT05877027 | Completed

• 1 other identifier: 4370438302
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis, the most common type of arthritis, is a chronic and degenerative joint disease. It has been reported to affect more than 300 million adults and elderly individuals worldwide. The joint most commonly affected by osteoarthritis is the knee joint and this condition is called gonarthrosis. The goal of treatment is to reduce symptoms and ultimately slow the progression of the disease with various treatment options throughout the course of the disease.Current clinical studies 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) According to the guidelines, treatment typically includes physiotherapy interventions with the use of non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics, including intra-articular injections of corticosteroids. Exercise-oriented physiotherapy is one of the main approaches for the conservative treatment of gonarthrosis. The curative clinical effect of exercise therapy on pain and functional disability in gonarthrosis is important. The use of PRP in the treatment of gonarthrosis is based on the ability of platelets to release biologically active proteins and promote tissue healing. Since the cartilage tissue mainly affected in gonarthrosis has low healing potential, this feature of platelets becomes more important for the target tissue. Existing studies show that PRP is superior to hyaluronic acid in intermediate and initial gonarthrosis; on the other hand, less satisfactory results are reported in severe gonarthrosis, similar to viscosupplementation. Topically or orally administered NSAIDs form the backbone of pharmacological treatment in gonarthrosis. It is seen that both exercise, PRP and topical NSAID agents are among the recommendations in the treatment of gonarthrosis. However, there is insufficient evidence regarding the superiority and therapeutic efficacy of these three treatment approaches. The aim of this study is to determine the effectiveness of "exercise", "PRP" and "NSAID-specific topical agents" in the treatment of patients with gonarthrosis; pain, function, quality of life, and patient satisfaction.

Conditions

Gonarthrosis

Keywords

Physiotherapy; Non-steroidal anti-inflammatory drugs; Intraarticular Injection; Osteoarthrosis

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. 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-12 Scale (SF-12)

  4 times for 24 weeks

Study Arms (3)

Intervention Group 1

ACTIVE COMPARATOR

The patients in the Exercise group will be treated with a structured exercise program. The exercises will be applied by the research physiotherapist for 6 weeks, 2 days a week. Each training session is planned to last approximately 30 minutes.

Other: Exercise

Intervention Group 2

ACTIVE COMPARATOR

The patients in the topical agent group were prescribed by the orthopedist. they will use the topical agent. Diclofenac in gel form was chosen as a topical agent in the light of the literature. In this context, patients in both groups will apply the topical agent around the knee joint 4 days a week, 2 times a day (every 12 hours) in the morning and evening for 6 weeks.

Other: Topical Diclofenac

Intervention Group 3

ACTIVE COMPARATOR

The PRP procedure with the same characteristics will be used in the treatment of patients in the PRP group. The PRP application will be prepared by the orthopedics and traumatology specialist physician in the research team, using the kits provided within the scope of the project. In order to collect venous blood for the PRP production procedure, gamma sterile vacuum tubes and blood collection set in special kits without the risk of contamination will be used. A total of 3 doses will be administered to the patients, with a one-week interval between doses.

Other: Platelet-Rich-Plasma (PRP)

Interventions

Exercise OTHER

The first 3 weeks of the exercise program will include range of motion exercises, isometric and isotonic strengthening exercises for the muscles around the knee and hip, and stretching exercises. In the following 3 weeks, resistance strengthening exercises and closed kinetic chain exercises will be added to the program.

Intervention Group 1

Topical Diclofenac OTHER

They will apply it around the knee joint 4 days a week, 2 times a day (every 12 hours), morning and evening for 6 weeks.

Intervention Group 2

Platelet-Rich-Plasma (PRP) OTHER

8 ml of blood will be taken from each patient in tubes containing 0.9 ml of 3.2% sodium citrate. Swing-out rotor (open-swing type) will be placed in the centrifuge with the tubes facing each other. After centrifugation, 2.5 cc of PRP product will be collected from each tube and the resulting PRP will be administered to patients by injection under sterile conditions.

Intervention Group 3

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with gonarthrosis according to the criteria of the American Society of Rheumatology (ACR)
• 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 barriers to being included in the exercise program

You may not qualify if:

• Being in stage 4 according to Kellgren Lawrence radiological staging criteria,
• Hemoglobin level \<11.5 g/dL
• Platelet level \<100,000/μL
• Thrombocytopenia, coagulopathy, crystal arthropathy, hemophilia or hematological malignancy,
• Presence of active infection or tumor,
• Chronic antiaggregant use or taking immunosuppressive therapy,
• Pregnancy or lactation,
• Viscosupplementation or steroid injection in the related knee in the last 3 months, or using systemic steroids,
• 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 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

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  PMID: 32398285 BACKGROUND

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  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.

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• 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.

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• 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; Osteoarthritis

Interventions

Exercise; Diclofenac

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Sezen Karabörklü Argut, PhD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator administering the treatment and the investigator performing the evaluations will be different. The evaluator will not know about the interventions that the participants received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 26, 2023
• Study Start: March 20, 2024
• Primary Completion: March 18, 2025
• Study Completion: May 18, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-01

Locations

TU (1)