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Effect of corticosteroid injection for trochanter pain syndrome: design of a randomised clinical trial in general practice

BACKGROUND: Regional pain in the hip in adults is a common cause of a general practitioner visit. A considerable part of patients suffer from (greater) trochanteric pain syndrome or trochanteric bursitis. Local corticosteroid injections is one of the treatment options. Although clear evidence is lac...

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Autores principales: Brinks, Aaltien, van Rijn, Rogier M, Bohnen, Arthur M, Slee, Gabriël LJ, Verhaar, Jan AN, Koes, Bart W, Bierma-Zeinstra, Sita MA
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2007
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2045096/
https://www.ncbi.nlm.nih.gov/pubmed/17880718
http://dx.doi.org/10.1186/1471-2474-8-95
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author Brinks, Aaltien
van Rijn, Rogier M
Bohnen, Arthur M
Slee, Gabriël LJ
Verhaar, Jan AN
Koes, Bart W
Bierma-Zeinstra, Sita MA
author_facet Brinks, Aaltien
van Rijn, Rogier M
Bohnen, Arthur M
Slee, Gabriël LJ
Verhaar, Jan AN
Koes, Bart W
Bierma-Zeinstra, Sita MA
author_sort Brinks, Aaltien
collection PubMed
description BACKGROUND: Regional pain in the hip in adults is a common cause of a general practitioner visit. A considerable part of patients suffer from (greater) trochanteric pain syndrome or trochanteric bursitis. Local corticosteroid injections is one of the treatment options. Although clear evidence is lacking, small observational studies suggest that this treatment is effective in the short-term follow-up. So far, there are no randomised controlled trials available evaluating the efficacy of injection therapy. This study will investigate the efficacy of local corticosteroid injections in the trochanter syndrome in the general practice, using a randomised controlled trial design. The cost effectiveness of the corticosteroid injection therapy will also be assessed. Secondly, the role of co-morbidity in relation to the efficacy of local corticosteroid injections will be investigated. METHODS/DESIGN: This study is a pragmatic, open label randomised trial. A total of 150 patients (age 18–80 years) visiting the general practitioner with complaints suggestive of trochanteric pain syndrome will be allocated to receive local corticosteroid injections or to receive usual care. Usual care consists of analgesics as needed. The randomisation is stratified for yes or no co-morbidity of low back pain, osteoarthritis of the hip, or both. The treatment will be evaluated by means of questionnaires at several time points within one year, with the 3 month and 1 year evaluation of pain and recovery as primary outcome. Analyses of primary and secondary outcomes will be made according to the intention-to-treat principle. Direct and indirect costs will be assessed by questionnaires. The cost effectiveness will be estimated using the following ratio: CE ratio = (cost of injection therapy minus cost of usual care)/(effect of injection therapy minus effect of usual care). DISCUSSION: This study design is appropriate to estimate effectiveness and cost-effectiveness of the injection therapy. We choose to use a pragmatic study design and are thus not able to study specific effects of the injection with corticosteroids. A distinction between placebo effect of the injection and specific effects of the corticosteroids is therefore not possible. TRIAL REGISTRATION: The trial is listed in the Dutch Trial Registry with the number ISRCTN16994576
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spelling pubmed-20450962007-10-30 Effect of corticosteroid injection for trochanter pain syndrome: design of a randomised clinical trial in general practice Brinks, Aaltien van Rijn, Rogier M Bohnen, Arthur M Slee, Gabriël LJ Verhaar, Jan AN Koes, Bart W Bierma-Zeinstra, Sita MA BMC Musculoskelet Disord Study Protocol BACKGROUND: Regional pain in the hip in adults is a common cause of a general practitioner visit. A considerable part of patients suffer from (greater) trochanteric pain syndrome or trochanteric bursitis. Local corticosteroid injections is one of the treatment options. Although clear evidence is lacking, small observational studies suggest that this treatment is effective in the short-term follow-up. So far, there are no randomised controlled trials available evaluating the efficacy of injection therapy. This study will investigate the efficacy of local corticosteroid injections in the trochanter syndrome in the general practice, using a randomised controlled trial design. The cost effectiveness of the corticosteroid injection therapy will also be assessed. Secondly, the role of co-morbidity in relation to the efficacy of local corticosteroid injections will be investigated. METHODS/DESIGN: This study is a pragmatic, open label randomised trial. A total of 150 patients (age 18–80 years) visiting the general practitioner with complaints suggestive of trochanteric pain syndrome will be allocated to receive local corticosteroid injections or to receive usual care. Usual care consists of analgesics as needed. The randomisation is stratified for yes or no co-morbidity of low back pain, osteoarthritis of the hip, or both. The treatment will be evaluated by means of questionnaires at several time points within one year, with the 3 month and 1 year evaluation of pain and recovery as primary outcome. Analyses of primary and secondary outcomes will be made according to the intention-to-treat principle. Direct and indirect costs will be assessed by questionnaires. The cost effectiveness will be estimated using the following ratio: CE ratio = (cost of injection therapy minus cost of usual care)/(effect of injection therapy minus effect of usual care). DISCUSSION: This study design is appropriate to estimate effectiveness and cost-effectiveness of the injection therapy. We choose to use a pragmatic study design and are thus not able to study specific effects of the injection with corticosteroids. A distinction between placebo effect of the injection and specific effects of the corticosteroids is therefore not possible. TRIAL REGISTRATION: The trial is listed in the Dutch Trial Registry with the number ISRCTN16994576 BioMed Central 2007-09-19 /pmc/articles/PMC2045096/ /pubmed/17880718 http://dx.doi.org/10.1186/1471-2474-8-95 Text en Copyright © 2007 Brinks et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Brinks, Aaltien
van Rijn, Rogier M
Bohnen, Arthur M
Slee, Gabriël LJ
Verhaar, Jan AN
Koes, Bart W
Bierma-Zeinstra, Sita MA
Effect of corticosteroid injection for trochanter pain syndrome: design of a randomised clinical trial in general practice
title Effect of corticosteroid injection for trochanter pain syndrome: design of a randomised clinical trial in general practice
title_full Effect of corticosteroid injection for trochanter pain syndrome: design of a randomised clinical trial in general practice
title_fullStr Effect of corticosteroid injection for trochanter pain syndrome: design of a randomised clinical trial in general practice
title_full_unstemmed Effect of corticosteroid injection for trochanter pain syndrome: design of a randomised clinical trial in general practice
title_short Effect of corticosteroid injection for trochanter pain syndrome: design of a randomised clinical trial in general practice
title_sort effect of corticosteroid injection for trochanter pain syndrome: design of a randomised clinical trial in general practice
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2045096/
https://www.ncbi.nlm.nih.gov/pubmed/17880718
http://dx.doi.org/10.1186/1471-2474-8-95
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