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Corticosteroid injections in patients with trochanteric pain syndrome: open label randomized clinical trial in general practice.


- candidate number2041
- NTR NumberNTR640
- ISRCTNISRCTN16994576
- Date ISRCTN created28-apr-2006
- date ISRCTN requested25-apr-2006
- Date Registered NTR27-mrt-2006
- Secondary IDsN/A 
- Public TitleCorticosteroid injections in patients with trochanteric pain syndrome: open label randomized clinical trial in general practice.
- Scientific TitleCorticosteroid injections in patients with trochanteric pain syndrome: open label randomized clinical trial in general practice.
- ACRONYMTIS = Trochanter Injection Study
- hypothesisLocal corticosteroid injections combined with usual care will have a positive effect on experienced recovery and will reduce pain at 3 and 12 months follow up compared to usual care alone.
- Healt Condition(s) or Problem(s) studiedTrochanteric pain
- Inclusion criteriaPatients aged 18 till 80 consulting the general practitioner with trochanteric hip pain existing longer then one week, with the following signs:
1. Severe local pain by pressure at the trochanter major, but unsure whether the patient recognizes this as the pain he/she consulted for;
2. Local pain by pressure at the trochanter major, which thepatient recognizes as the pain he/she consulted for.
- Exclusion criteria1. Patients who donít understand the questionnaires because of inadequate mastering of Dutch language or cognitive disorders;
2. Patients who presented themselves in the previous year to the GP with the same complaints;
3. Patients with sensibility disorders due to meralgia paresthetica, patients who previously have undergone hip surgery at the same side and patients with systematic rheumatologic or neurologic disorders.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2006
- planned closingdate1-mei-2007
- Target number of participants150
- Interventions1. Intervention group: Usual care combined with corticosteroid injections (triamcenalonacetaat 40 mg, lidocaine 1%);

2. Control group: Usual care.
- Primary outcomeExperienced recovery (7 points Likert scale) and severity of pain (0-10 VAS) at 3 months follow up.
- Secondary outcome1. Disease specific outcomes of pain and function (WOMAC/HOOS), at 3 and 12 months follow up;
2. Primary outcomes at 6 weeks and at 6, 9 and 12 months follow-up;
3. Cost effectiveness over 12 months of follow-up. Costs will be estimated by medical consumption, and productivity loss (PRODISC).
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESPhD. S. Bierma-Zeinstra
- CONTACT for SCIENTIFIC QUERIES A. Brinks
- Sponsor/Initiator Erasmus Medical Center, Department of General Practice
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryA remarkable part of patients with hip pain suffer from trochanteric pain syndrome. In this study (cost) effectiveness of local corticosteroid injections will be determined regarding to normal policy in patients with local trochanteric pain syndrome in general practice.
- Main changes (audit trail)
- RECORD27-mrt-2006 - 27-nov-2009


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