| - candidate number | 2454 |
| - NTR Number | NTR898 |
| - ISRCTN | ISRCTN75642432 |
| - Date ISRCTN created | 26-feb-2007 |
| - date ISRCTN requested | 21-feb-2007 |
| - Date Registered NTR | 9-feb-2007 |
| - Secondary IDs | N/A |
| - Public Title | Is a simultaneaus intervention of triamcinolon injections with standardized exercises more effective compared to the usual care according to the NHG standard in patients with shoulder complaints. A prospective, singel blind, randomized clinical trial. |
| - Scientific Title | Is a simultaneaus intervention of triamcinolon injections with standardized exercises more effective compared to the usual care according to the NHG standard in patients with shoulder complaints. A prospective, singel blind, randomized clinical trial. |
| - ACRONYM | Investigation of the efficacy of shoulder injections |
| - hypothesis | The aim of the present study is whether a simultaneus intervention with (maximal 5) corticosteroïd/lidocaine injections and exercises for the cuff muscles (both according a standard protocol), have better results than a sequential intervention of first (maximal 5) corticosteroïden/lidocaine injections followed after 6 weeks by exercises (usual care, according to NHG standard) in a group of patients with shoulder complaints |
| - Healt Condition(s) or Problem(s) studied | Complaints of shoulder, Triamcinolone injections, NHG standard, Exercises, Efficacy |
| - Inclusion criteria | 1. Patients with shoulder complaints consulting their GP; 2. Presence of painfull-arc and restricted range of motion. |
| - Exclusion criteria | 1. Not signed informed consent form; 2. Age under 18 or above 70 year; 3. Treatment (exercises or corticosteroid injections) of shoulder complaints during the last 6 months; 4. Insufficient command of the Dutch language, spoken and/or written. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-jun-2007 |
| - planned closingdate | 31-mei-2010 |
| - Target number of participants | 205 |
| - Interventions | Group A: a simultaneus intervention in which the patients will be injected with a combination of lidocaine and 1 ml Kenacort A40 and at the same time exercises; and group B in which the patient will be injected with a combination of lidocaine and 1 ml Kenacort A40 and after six weeks according to the NHG-standard with exercises. |
| - Primary outcome | The primary outcome is the change in pain in rest, during activities or during the night of the last 24 hours, between baseline and 78 weeks. |
| - Secondary outcome | Change compared to the baseline assessments of: 1. DASH questionnaire; 2. SF36 questionnaire; 3. Analgetica use; 4. Participant rated improvement; 5. Range of Motion maesurements; 6. Painful-Arc; 7. Complications of injections. |
| - Timepoints | |
| - Trial web site | |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | B.J Berkhout |
| - CONTACT for SCIENTIFIC QUERIES | B.J Berkhout |
| - Sponsor/Initiator | Erasmus Medical Center, Department of Orthopaedics |
| - Funding (Source(s) of Monetary or Material Support) | Erasmus Medical Center, Department of Orthopaedics |
| - Publications | N/A |
| - Brief summary | In the Netherlands the preponderance of patients with shoulder complaints are treated by their general practitioner. The NHG-standard of 1999 advises two-weekly injections with triamcinolonacetonide subacromial or intra-articulair, dependent on the physical examination of the patient. If the shoulder complaints are still present after 6 weeks of fysiotherapy can be considered. Our hypothesis is that a simultaneous intervention of injections with a combination of lidocaine and 1 ml Kenacort A40 subacromial or intra-articular, in combination with simultaneous fysiotherapy (standardized training program) is more effective compared to the usual care (NHG standard). The primary outcome is the change in pain in rest, during activities or during the night of the last 24 hours, between baseline and 78 weeks. In total 205 patients will be recruited. Patients will be concealed randomized into 2 groups, group A; a simultaneous intervention in which the patients will be injected with a combination of lidocaine and 1 ml Kenacort A40 and at the same time exercises; and group B; in which the patient will be injected with a combination of lidocaine and 1 ml Kenacort A40 and after six weeks according to the NHG-standard with exercises. The procedure of injection will be according to the NHG-standard. The follow-up measurements will be at 6, 12, 26, 52 and 78 weeks. |
| - Main changes (audit trail) | |
| - RECORD | 9-feb-2007 - 26-feb-2007 |
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