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…
ID
Bron
Verkorte titel
Aandoening
"triamcinolon injections" "NHG standard" "exercises" "efficacy" "shoulder complaints"
"triamcinolon injecties"NHG standaard" "oefeningen"
"effectiviteit" "schouder klachten"
Ondersteuning
Erasmus MC
Department of Orthopaedics
Room Hs-104
PO Box 2040
3000 CA Rotterdam
Email: m.reijman@erasmusmc.nl
tel: 010-4633642
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients with shoulder complaints consulting their GP;
2. Presence of painfull-arc and restricted range of motion.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL883 |
NTR-old | NTR898 |
Ander register | : N/A |
ISRCTN | ISRCTN75642432 |