To determine whether doubling the dose of triamcinolone injections in the treatment of arthritis in knee joints is more effective, both in number of responding patients and in duration of response (pain relief).
Conditions
Interventions
Trade Name: Kenacort A-40
Product Name: Kenacort A-40
Product Code: RVG05341
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: triamcinolonum acetonidum
CAS Number: 76-25-5
Current Sp
Sponsors
Ziekenhuisgroep Twente
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Arthritis patients, RA or other causes of chronic systemic arthritis (not osteoarthritis and gout) with an indication for local injection with corticosteroid in knee joint. • Patients should have stable anti-arthritic co-medication, no changes will be made during the trial. • Patients need to score at least ‘matig’ at a 5-point Likert scale at the initial questionnaire at t = 0 otherwise no significant difference can be measured. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Contraindication for local injection with corticosteroid (infection, relevant skin lesion, uncontrolled diabetes mellitus) • Chronic (>3 months) or current use of more than 10mg prednisolone or equivalent daily. • No informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether doubling the dose of corticosteroid injections in the treatment of arthritis in knee joints is more effective in the relief of symptoms as measured by change in the assessment of arthritis burden by the patient on a Likert 5-point scale, both in number of responding patients and in duration of response.;Secondary Objective: To determine the percentage of patients with good response in symptomatic relief at individual weekly time points To determine the duration of response To determine the time to good response To determine the arthritis activity assessed by the trial physician on a 5 point Likert scale VAS pain at t = 0 and t = 12 weeks To determine the change in Range of Motion (ROM) on physical examination, To determine the change of swelling on physical examination To determine the change in patients health status by making use of The Western Ontario McMaster Universities Osteoarthritis index (WOMAC) at t = 0 and t = 12 weeks. ;Primary end point(s): Primary Objective: To determine whether doubling the dose of corticosteroid injections in the treatment of arthritis in knee joint is more effective in the relief of symptoms as measured by perceived change by the patient on a Likert 5-point scale, both in number of responding patients and in duration of response. | — |
Countries
Netherlands
Outcome results
None listed