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Double Dose Treatment: Corticosteroid injection therapy in arthritis.


- candidate number8022
- NTR NumberNTR2298
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-apr-2010
- Secondary IDsP10-10 METC Enschede
- Public TitleDouble Dose Treatment: Corticosteroid injection therapy in arthritis.
- Scientific TitleDouble Dose Treatment: Corticosteroid injection therapy in arthritis.
- ACRONYMDoDo
- hypothesisTo 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).
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis, Arthritis, Kenacort
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2010
- planned closingdate1-jul-2011
- Target number of participants94
- InterventionsPatients 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.
- Primary outcomePercentage of patients with sustained good response.
- Secondary outcome1. 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.
- Timepointst = 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 weeks.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdrs. J.W. Popma
- CONTACT for SCIENTIFIC QUERIESdrs. J.W. Popma
- Sponsor/Initiator Ziekenhuisgroep Twente
- Funding
(Source(s) of Monetary or Material Support)
Ziekenhuisgroep Twente
- PublicationsN/A
- Brief summaryInjections 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.
- Main changes (audit trail)
- RECORD27-apr-2010 - 9-mei-2010


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