- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05139875
Comparing Intra-articular Betamethasone (Diprospan) and Triamcinolone Acetonide Injection in Knee Osteoarthritis
January 1, 2024 updated by: Kittipong Wattanasirisombat, Thammasat University
A Comparative Study of Betamethasone (Diprospan) and Triamcinolone Acetonide as Single Intra-Articular Injection in Knee Osteoarthritis, A Double-Blinded, Randomized Controlled Trial
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed 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
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pathumthani
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Khlong Luang, Pathumthani, Thailand, 12120
- Thammasat University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Symptomatic Primary knee osteoarthritis (Kellgren-Lawrence stage 2 or 3)
- Failed other conservative treatment
- Comply with protocol
Exclusion Criteria:
- Allergy to any of the medications in this protocol (Betamethasone, Triamcinolone, Paracetamol, Tramadol)
- Previous fracture or surgical procedure
- Previous intra-articular injection in the past 6 months
- Previous oral Symptomatic slow-acting drugs for osteoarthritis (SYSADOA) (Glucosamine, Diacerein) used in the past 6 months
- Current infection in the affected limb
- Uncontrolled Diabetes Mellitus
- Primary or secondary adrenal insufficiency
- Coagulopathy or current anticoagulant used
- Current steroid used
- Lower extremity weakness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Betamethasone (Diprospan)
Participant received single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate 1 ml
|
Single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate (Diprospan) injections to affected knee
Other Names:
|
Active Comparator: Triamcinolone acetonide
Participant received single intra-articular Triamcinolone acetonide 40 mg
|
Single intra-articular Triamcinolone Acetonide injections to affected knee
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference of 100-mm Visual analog scale (VAS) Pain Score between Betamethasone (Diprospan) and Triamcinolone group
Time Frame: 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
|
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference of Modified Western Ontario and McMaster Universities Arthritis Index (WOMAC) score between Betamethasone (Diprospan) and Triamcinolone group
Time Frame: Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
|
|
Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
|
Difference of University of California and Los Angeles (UCLA) score between Betamethasone (Diprospan) and Triamcinolone group
Time Frame: Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
|
|
Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
|
Difference of Range of motion between Betamethasone (Diprospan) and Triamcinolone group
Time Frame: Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
|
- 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
|
Difference of Time up-and-go test between Betamethasone (Diprospan) and Triamcinolone group
Time Frame: Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
|
|
Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
|
Difference of 2-minutes walking test between Betamethasone (Diprospan) and Triamcinolone group
Time Frame: Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
|
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Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection
|
Incidence of side effects of intra-articular steroid injection
Time Frame: 1 month, 3 months, 6 months after intra-articular 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
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Difference of Total Paracetamol and Tramadol used between Betamethasone (Diprospan) and Triamcinolone group
Time Frame: 6 months after intra-articular injection
|
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6 months after intra-articular injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: KITTIPONG WATTANASIRISOMBAT, MD, Thammasat University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. Erratum In: Arthritis Rheumatol. 2021 May;73(5):799.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
November 18, 2021
First Submitted That Met QC Criteria
November 18, 2021
First Posted (Actual)
December 1, 2021
Study Record Updates
Last Update Posted (Estimated)
January 3, 2024
Last Update Submitted That Met QC Criteria
January 1, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Betamethasone
- Betamethasone Valerate
- Betamethasone-17,21-dipropionate
- Betamethasone benzoate
- Betamethasone sodium phosphate
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
- Betamethasone dipropionate, betamethasone sodium phosphate drug combination
Other Study ID Numbers
- MTU-EC-OT-1-266/64
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
- Researchers who provide a methodologically sound proposal.
- To achieve aims in the approved proposal.
- Proposals should be directed to kittipong43705@gmail.com.
- To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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