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

NCT05139875 | Completed Phase 4 DMC

• 1 other identifier: MTU-EC-OT-1-266/64
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Knee Osteoarthritis

Keywords

Intra-articular injections; Corticosteroids; Triamcinolone acetonide; Betamethasone; Nonoperative management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Difference of Modified Western Ontario and McMaster Universities Arthritis Index (WOMAC) score between Betamethasone (Diprospan) and Triamcinolone group

  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

  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

  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

  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

  Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection

Study Arms (2)

Betamethasone (Diprospan)

EXPERIMENTAL

Participant received single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate 1 ml

Drug: Betamethasone Dipropionate / Betamethasone Sodium Phosphate

Triamcinolone acetonide

ACTIVE COMPARATOR

Participant received single intra-articular Triamcinolone acetonide 40 mg

Drug: Triamcinolone Acetonide 40mg/mL

Interventions

Betamethasone Dipropionate / Betamethasone Sodium Phosphate DRUG

Single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate (Diprospan) injections to affected knee

Also known as: Diprospan

Betamethasone (Diprospan)

Triamcinolone Acetonide 40mg/mL DRUG

Single intra-articular Triamcinolone Acetonide injections to affected knee

Also known as: Kanolone-F

Triamcinolone acetonide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic Primary knee osteoarthritis (Kellgren-Lawrence stage 2 or 3)
• Failed other conservative treatment
• Comply with protocol

You may not qualify if:

• 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

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Thammasat University Hospital

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

Related Publications (16)

• 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.

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• 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.

  PMID: 34035002 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

• 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

• 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.

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  PMID: 31709838 BACKGROUND

• 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.

  PMID: 24651914 BACKGROUND

• 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.

  PMID: 22698422 RESULT

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  PMID: 15712981 RESULT

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  PMID: 16271901 RESULT

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  PMID: 1101375 RESULT

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  PMID: 23947590 RESULT

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  PMID: 22057944 RESULT

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  PMID: 17461394 RESULT

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  PMID: 11354213 RESULT

• 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.

  PMID: 17310271 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

betamethasone-17,21-dipropionate; betamethasone sodium phosphate; betamethasone dipropionate, betamethasone sodium phosphate drug combination; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• KITTIPONG WATTANASIRISOMBAT, MD

  Thammasat University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 1. Participant and Care Provider will not know which drug is injected to the investigated knee because the opaque syringe is used to inject. 2. Investigator and outcomes assessor will not known the group of participants because randomization, they only know the number of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Participants are randomized and assigned to betamethasone (Diprospan) group or Triamcinolone acetonide group in parallel for the duration of the study

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 1, 2021
• Study Start: January 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)