Comparing Intra-articular Betamethasone (Diprospan) and Triamcinolone Acetonide Injection in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

A Comparative Study of Betamethasone (Diprospan) and Triamcinolone Acetonide as Single Intra-Articular Injection in Knee Osteoarthritis, A Double-Blinded, Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05139875
• Other study ID #: MTU-EC-OT-1-266/64
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy of Intra-articular corticosteroid injection between Betamethasone (Diprospan) and Triamcinolone acetonide for treatment of knee osteoarthritis

Description:

After being informed about the study and potential risks, all patients giving written informed consent will be chosen for eligibility for the study entry. At day 0 (before intra-articular injection), patients who meet the eligibility criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Betamethasone (Diprospan 1 ml) or Triamcinolone acetonide (40 mg) single intra-articular injection

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Symptomatic Primary knee osteoarthritis (Kellgren-Lawrence stage 2 or 3)

2. Failed other conservative treatment

3. Comply with protocol

Exclusion Criteria:

1. Allergy to any of the medications in this protocol (Betamethasone, Triamcinolone, Paracetamol, Tramadol)

2. Previous fracture or surgical procedure

3. Previous intra-articular injection in the past 6 months

4. Previous oral Symptomatic slow-acting drugs for osteoarthritis (SYSADOA) (Glucosamine, Diacerein) used in the past 6 months

5. Current infection in the affected limb

6. Uncontrolled Diabetes Mellitus

7. Primary or secondary adrenal insufficiency

8. Coagulopathy or current anticoagulant used

9. Current steroid used

10. Lower extremity weakness

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Betamethasone Dipropionate / Betamethasone Sodium Phosphate
Single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate (Diprospan) injections to affected knee
• Triamcinolone Acetonide 40mg/mL
Single intra-articular Triamcinolone Acetonide injections to affected knee

Locations

Country	Name	City	State
Thailand	Thammasat University Hospital	Khlong Luang	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

References & Publications (16)

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

Cole BJ, Schumacher HR Jr. Injectable corticosteroids in modern practice. J Am Acad Orthop Surg. 2005 Jan-Feb;13(1):37-46. doi: 10.5435/00124635-200501000-00006. — View Citation

Douglas RJ. Corticosteroid injection into the osteoarthritic knee: drug selection, dose, and injection frequency. Int J Clin Pract. 2012 Jul;66(7):699-704. doi: 10.1111/j.1742-1241.2012.02963.x. — View Citation

Garg N, Perry L, Deodhar A. Intra-articular and soft tissue injections, a systematic review of relative efficacy of various corticosteroids. Clin Rheumatol. 2014 Dec;33(12):1695-706. doi: 10.1007/s10067-014-2572-8. Epub 2014 Mar 21. — View Citation

Husby G, Kass E, Spongsveen KL. Comparative double-blind trial of intra-articular injections of two long-acting forms of betamethasone. Scand J Rheumatol. 1975;4(3):118-20. doi: 10.3109/03009747509165439. — View Citation

Jevsevar DS, Brown GA, Jones DL, Matzkin EG, Manner PA, Mooar P, Schousboe JT, Stovitz S, Sanders JO, Bozic KJ, Goldberg MJ, Martin WR 3rd, Cummins DS, Donnelly P, Woznica A, Gross L; American Academy of Orthopaedic Surgeons. The American Academy of Orthopaedic Surgeons evidence-based guideline on: treatment of osteoarthritis of the knee, 2nd edition. J Bone Joint Surg Am. 2013 Oct 16;95(20):1885-6. doi: 10.2106/00004623-201310160-00010. No abstract available. — 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

Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001 May;18(3):205-7. doi: 10.1136/emj.18.3.205. — 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

Kuptniratsaikul V, Rattanachaiyanont M. Validation of a modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis. Clin Rheumatol. 2007 Oct;26(10):1641-5. doi: 10.1007/s10067-007-0560-y. Epub 2007 Feb 2 — View Citation

Liu D, Ahmet A, Ward L, Krishnamoorthy P, Mandelcorn ED, Leigh R, Brown JP, Cohen A, Kim H. A practical guide to the monitoring and management of the complications of systemic corticosteroid therapy. Allergy Asthma Clin Immunol. 2013 Aug 15;9(1):30. doi: — View Citation

Oo WM, Liu X, Hunter DJ. Pharmacodynamics, efficacy, safety and administration of intra-articular therapies for knee osteoarthritis. Expert Opin Drug Metab Toxicol. 2019 Dec;15(12):1021-1032. doi: 10.1080/17425255.2019.1691997. Epub 2019 Nov 13. — View Citation

Schumacher HR, Chen LX. Injectable corticosteroids in treatment of arthritis of the knee. Am J Med. 2005 Nov;118(11):1208-14. doi: 10.1016/j.amjmed.2005.05.003. — View Citation

Uson J, Rodriguez-Garcia SC, Castellanos-Moreira R, O'Neill TW, Doherty M, Boesen M, Pandit H, Moller Parera I, Vardanyan V, Terslev L, Kampen WU, D'Agostino MA, Berenbaum F, Nikiphorou E, Pitsillidou IA, de la Torre-Aboki J, Carmona L, Naredo E. EULAR recommendations for intra-articular therapies. Ann Rheum Dis. 2021 Oct;80(10):1299-1305. doi: 10.1136/annrheumdis-2021-220266. Epub 2021 May 25. — View Citation

Wollstein R, Chaimsky G, Carlson L, Watson HK, Wollstein G, Saleh J. Evaluating short-term pain after steroid injection. Am J Orthop (Belle Mead NJ). 2007 Mar;36(3):128-31. — View Citation

Yavuz U, Sokucu S, Albayrak A, Ozturk K. Efficacy comparisons of the intraarticular steroidal agents in the patients with knee osteoarthritis. Rheumatol Int. 2012 Nov;32(11):3391-6. doi: 10.1007/s00296-011-2188-0. Epub 2011 Nov 5. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of 100-mm Visual analog scale (VAS) Pain Score between Betamethasone (Diprospan) and Triamcinolone group	The 100-mm VAS pain score is a self-reported instrument assessing Pain Score at 1 day, 2 days, 3 days, 1 week, 3 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months after the day of intra-articular injection; Participants will assess the VAS pain score at rest and on-movement; VAS Pain at rest is evaluated when the participant's wakeup in the morning; VAS Pain on-movement is evaluated when the participant's walking for 10 meters and then resting for 5 minutes; Possible scores range from 0 (no pain) to 100 (worst imaginable pain); Higher scores mean a worse pain	Baseline before intra-articular injection, 1 day, 2 days, 3 days, 1 week, 3 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months after the day of intra-articular injection
Secondary	Difference of Modified Western Ontario and McMaster Universities Arthritis Index (WOMAC) score between Betamethasone (Diprospan) and Triamcinolone group	The Modified WOMAC score is a validated, self-reported instrument consisting of 24 items divided into 3 subscales (Pain, Stiffness, Physical function).; The test questions are scored on a scale of 0-4, which corresponds to None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).; Possible scores range from 0-20 for pain, 0-8 for Stiffness, 0-68 for Physical function.; a sum of the scores for all three subscales gives a total WOMAC score (0-96); Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.	Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
Secondary	Difference of University of California and Los Angeles (UCLA) score between Betamethasone (Diprospan) and Triamcinolone group	The UCLA is a 10-point scale measurement that evaluates patients' daily activity levels.; The 10-point scale is leveled from 1 to 10 (1= worst, 10 = best).; Level 1 is wholly inactive and dependent on others, while level 6 is unlimited housework and shopping and level 10 is regular participation in impact sports, such as jogging or tennis.	Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
Secondary	Difference of Range of motion between Betamethasone (Diprospan) and Triamcinolone group	- Flexion and extension angle of the knee is measured by a long-arm goniometer	Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
Secondary	Difference of Time up-and-go test between Betamethasone (Diprospan) and Triamcinolone group	The Time up-and-go test (TUGT) measures the time (seconds) that the patient takes to rise from a chair and walk for 3 meters. Then, he or she turns around and comes back to the seat at the initial position.; They were permitted to use walking aids if they wished.; TUGT was a reliable and valid test for quantifying functional mobility.	Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
Secondary	Difference of 2-minutes walking test between Betamethasone (Diprospan) and Triamcinolone group	Participants were instructed to walk for 2 minutes at their normal pace up and down a designated corridor, turning around at each end of the corridor without stopping; They were permitted to use walking aids if they wished.; The results were recorded as the total distance walked in meters.	Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
Secondary	Incidence of side effects of intra-articular steroid injection	Injection site reaction, Erythema, Swelling, Injection-site pain, Pruritus, cellulitis were observed after intra-articular injection.	1 month, 3 months, 6 months after intra-articular injection
Secondary	Difference of Total Paracetamol and Tramadol used between Betamethasone (Diprospan) and Triamcinolone group	Post-injection protocol, Participants can use Paracetamol 500 mg 2 tabs every 4 hours for knee pain if it did not relieve the pain they can take Tramadol 50 mg 1 cap every 6 hours.; The total use of Paracetamol and Tramadol was recorded. (tablet)	6 months after intra-articular injection