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

Phase 1

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
vertical clefts and eventual exposure of subchondral bone and eburnation
MedDRA version: 19.0Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2016-001906-41-IE

Lead Sponsor: Royal College of Surgeons in Ireland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures