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Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

BACKGROUND: Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency an...

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Autores principales: Walker, Bruce F, Losco, Barrett, Clarke, Brenton R, Hebert, Jeff, French, Simon, Stomski, Norman J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3224760/
https://www.ncbi.nlm.nih.gov/pubmed/22040597
http://dx.doi.org/10.1186/1745-6215-12-235
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author Walker, Bruce F
Losco, Barrett
Clarke, Brenton R
Hebert, Jeff
French, Simon
Stomski, Norman J
author_facet Walker, Bruce F
Losco, Barrett
Clarke, Brenton R
Hebert, Jeff
French, Simon
Stomski, Norman J
author_sort Walker, Bruce F
collection PubMed
description BACKGROUND: Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. METHODS: One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000542998
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spelling pubmed-32247602011-11-28 Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial Walker, Bruce F Losco, Barrett Clarke, Brenton R Hebert, Jeff French, Simon Stomski, Norman J Trials Study Protocol BACKGROUND: Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. METHODS: One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000542998 BioMed Central 2011-10-31 /pmc/articles/PMC3224760/ /pubmed/22040597 http://dx.doi.org/10.1186/1745-6215-12-235 Text en Copyright ©2011 Walker 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
Walker, Bruce F
Losco, Barrett
Clarke, Brenton R
Hebert, Jeff
French, Simon
Stomski, Norman J
Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial
title Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial
title_full Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial
title_fullStr Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial
title_full_unstemmed Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial
title_short Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial
title_sort outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3224760/
https://www.ncbi.nlm.nih.gov/pubmed/22040597
http://dx.doi.org/10.1186/1745-6215-12-235
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