No registrations found.
ID
Source
Brief title
Health condition
triamcinolon
triamcinolone
arthritis
RA
kenacort
Sponsors and support
Zilvermeeuw 1,
7609 PP Almelo
+31(0)546 693 693
Intervention
Outcome measures
Primary outcome
Percentage of patients with sustained good response.
Secondary outcome
1. Percentage of patients with good response in symptomatic relief at individual weekly time points (at t = 2,3,4,5,6,7,8,9,10,11 weeks);
2. Duration of response: Time lapsed between reaching good response;
3. Time to good response;
4. Asessment of arthritis activity by the trial physician;
5. VAS pain at t = 0 and t = 12 weeks;
6. Change of Range of Motion (ROM) on physical examination;
7. Change of swelling on physical examination, as determined by the trial physician on T=0 and T=12 weeks;
8. Change in patients health status.
Background summary
Injections of corticosteroids are widely practised in rheumatology. Different kinds of corticosteroids are being used for local injection. Although local corticosteroid injections are widely practised, there are only few studies published in relationship with the response on the therapy. Factors predicting the response in pain relief of local corticosteroid injections are therefore largely unknown. A clinical dose-effect relationship has not yet been properly studied. The amount of drug being dosed is currently determined by clinical tradition.
Study objective
To determine whether doubling the dose of corticosteroid 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).
Study design
t = 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks.
Intervention
Patients will receive 40 or 80 mg triamcinolone (Kenacort) 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.
Inclusion criteria
1. Arthritis patients, RA or other causes of chronic arthritis (not osteoarthritis and not gout) with an indication for local injection with corticosteroid due to active arthritis in knee joint;
2. Patients should have stable anti-arthritic co-medication.
Exclusion criteria
1. Contraindication for local injection with corticosteroid (infection, relevant skin lesion, uncontrolled diabetes mellitus);
2. Chronic (>3 months) or current use of more than 10mg prednisolone or equivalent daily;
3. No informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2174 |
| NTR-old | NTR2298 |
| Other | METC Enschede : P10-10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |