Comparing Intra-articular Betamethasone (Diprospan) and Triamcinolone Acetonide Injection in Knee Osteoarthritis
NCT ID: NCT05139875
Last Updated: 2024-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
105 participants
INTERVENTIONAL
2022-01-01
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
2. Investigator and outcomes assessor will not known the group of participants because randomization, they only know the number of the participants.
Study Groups
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Betamethasone (Diprospan)
Participant received single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate 1 ml
Betamethasone Dipropionate / Betamethasone Sodium Phosphate
Single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate (Diprospan) injections to affected knee
Triamcinolone acetonide
Participant received single intra-articular Triamcinolone acetonide 40 mg
Triamcinolone Acetonide 40mg/mL
Single intra-articular Triamcinolone Acetonide injections to affected knee
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Failed other conservative treatment
3. Comply with protocol
Exclusion Criteria
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
ALL
No
Sponsors
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Thammasat University
OTHER
Responsible Party
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Kittipong Wattanasirisombat
Principal investigator
Principal Investigators
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KITTIPONG WATTANASIRISOMBAT, MD
Role: STUDY_DIRECTOR
Thammasat University
Locations
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Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, Thailand
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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: 10.1186/1710-1492-9-30.
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.
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.
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.
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 20.
Other Identifiers
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MTU-EC-OT-1-266/64
Identifier Type: -
Identifier Source: org_study_id
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