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NCT05139875 | Active, not recruiting | Knee Osteoarthritis


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

Thammasat University

Information provided by (Responsible Party):

Kittipong Wattanasirisombat

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

Condition or disease

Knee Osteoarthritis

Intervention/treatment

Betamethasone Dipropionate / Betamethasone Sodium Phosphate

Triamcinolone Acetonide 40mg/mL

Phase

Phase 4

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
Estimated Enrollment : 105 participants
Masking : Quadruple
Masking Description : Participant and Care Provider will not know which drug is injected to the investigated knee because the opaque syringe is used to inject. Investigator and outcomes assessor will not known the group of participants because randomization, they only know the number of the participants.
Primary Purpose : Treatment
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
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024
Arm Intervention/treatment

Experimental: Betamethasone (Diprospan)

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

Drug: Betamethasone Dipropionate / Betamethasone Sodium Phosphate

Active Comparator: Triamcinolone acetonide

Participant received single intra-articular Triamcinolone acetonide 40 mg

Drug: Triamcinolone Acetonide 40mg/mL

Ages Eligible for Study:
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

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

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

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Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Thailand, Let's go

Thammasat University Hospital

Khlong Luang, Pathumthani, Thailand, 12120

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