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A randomised control trial of knee injections for relief of pain in osteoarthritis: A comparison of corticosteroid and NSAID injections

A randomised control trial of intra articular injectates in knee osteoarthritis: A comparison of corticosteroid (Methylprednisolone Acetate) and NSAID (Ketorolac tromethamine) injections - A randomised control trial of intra articular injectates in knee osteoarthritis

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2016-001906-41-IE
Enrollment
Unknown
Registered
2016-06-08
Start date
2016-08-08
Completion date
Unknown
Last updated
2016-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis is the condition of interest. Osteoarthritis is a common musculoskeletal complaint, with an underlying pathogenesis related to bio-mechanical stress loading, resulting in initial changes within the articular cartilage, progressing to develop cartilage fibrillation

Interventions

Trade Name: Ketorolac Trometamol Product Name: Ketorolac Trometamol Product Code: SUB02835MIG Pharmaceutical Form: Solution for injection INN or Proposed INN: KETOROLAC TROMETAMOL CAS Number: 74103-

Sponsors

Royal College of Surgeons in Ireland
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Osteoarthritis of the knee, warranting intraarticular injection Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 39 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 39

Exclusion criteria

Exclusion criteria: Patients with a history of renal failure, peptic ulcer disease, or other contraindications to NSAID use Previous gastric bypass surgery Patients with a history of an allergy to NSAIDs Patients under 18 Patients unable to give consent to partake in the trial Inability to comprehend nature of the trial

Design outcomes

Primary

MeasureTime frame
Main Objective: We aim to compare the efficacy in achieving diminution of pain scores in persons with knee osteoarthritis between a standard injection of methylprednisolone and a non steroidal anti inflammatory (Depo-medrone and Keotorolac). ;Secondary Objective: Is the duration of action of the two modes of analgesia similar?;Primary end point(s): The outcome measures proposed are the Oxford Knee Score (OKS); Knee Injury and Osteoarthritis Outcome Score (KOOS); and the Western Ontario and McMaster University Osteoarthritis Index (WOMAC).;Timepoint(s) of evaluation of this end point: Comparisons to baseline, recorded prior to injection, will be carried out at 1; 2; 4; 6 weeks, by an assessor blinded to the treatment given

Secondary

MeasureTime frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A

Countries

Ireland

Contacts

Public ContactOrthopaedic Registrar

Dept of Orthopaedic Surgery, MRHT

iainfeeley@rcsi.ie3530579321501

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026