Exercise vs. Topical Diclofenac vs. PRP

Gonarthrosis Clinical Trial

Official title:

Comparison of Commonly Used Treatment Approaches in the Treatment of Gonarthrosis: Platelet-Rich Plasma, Topical Diclofenac, and Exercise

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05877027
• Other study ID #: 4370438302
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Sezen Karabörklü Argut, PhD
• Phone: +905301712421
• Email: s.karaborkluargut[@]iuc.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Voluntary participants who have been diagnosed with gonarthritis 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) topical diclofenac, c) platalet-rich-plasma (PRP).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: June 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gonarthrosis
• Osteoarthritis, Knee

Intervention

Other:
• Exercise
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.
• Topical Diclofenac
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.
• Platelet-Rich-Plasma (PRP)
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.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Arthritis Rheumatol. 2021 May;73(5):799. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	WOMAC	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.	4 times for 24 weeks
Secondary	40 meters fast walking test	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.	4 times for 24 weeks
Secondary	Stepping Test	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 times for 24 weeks
Secondary	Joint Range of Motion Evaluation	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.	4 times for 24 weeks
Secondary	Health-Related Quality of Life Short Form-12 Scale (SF-12)	SF-12 is the abbreviated version of the Short Form-36 (SF-36) 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.	4 times for 24 weeks
Secondary	Global Rating of Change Scale-GRC	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.	4 times for 24 weeks