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A randomised controlled trial of multimodal physiotherapy versus advice for recent onset, painful cervical radiculopathy – the PACeR trial protocol
BACKGROUND: A research gap exists for optimal management of cervical radiculopathy in the first 12 weeks and short term natural history of the condition is somewhat unclear, although thought to be favourable. The primary aim of this assessor blinded, superiority, 2 parallel group randomised controll...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6545204/ https://www.ncbi.nlm.nih.gov/pubmed/31153362 http://dx.doi.org/10.1186/s12891-019-2639-4 |
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author | Keating, Louise Treanor, Caroline Sugrue, Julie Meldrum, Dara Bolger, Ciaran Doody, Catherine |
author_facet | Keating, Louise Treanor, Caroline Sugrue, Julie Meldrum, Dara Bolger, Ciaran Doody, Catherine |
author_sort | Keating, Louise |
collection | PubMed |
description | BACKGROUND: A research gap exists for optimal management of cervical radiculopathy in the first 12 weeks and short term natural history of the condition is somewhat unclear, although thought to be favourable. The primary aim of this assessor blinded, superiority, 2 parallel group randomised controlled trial is to investigate the effects of a 4 week physiotherapy programme (6–8 sessions) of manual therapy, exercise and upper limb neural unloading tape, compared to a control of weekly phone advice; on disability, pain and selected biopsychosocial measures, in acute and sub-acute cervical radiculopathy patients. A secondary aim is to identify whether any baseline variables, symptom duration or group allocation can predict outcome. METHODS: Participants are recruited from GP referrals in an urban setting, from a neurosurgery non-urgent waiting list and from self-referral through Facebook advertising. Eligible participants (n = 64) are diagnosed with radiculopathy based on a clinical prediction rule and must have symptoms of unilateral, single level, radiculopathy for between 2 and 12 weeks, without having yet received physiotherapy. Random 1:1 group allocation (using variable block sizes), allocation concealment, blinded assessment and intention to treat analysis are being employed. Treatment is provided by clinical specialist physiotherapists in primary and secondary care settings. Outcomes are measured at baseline, 4 (primary endpoint) and 12 weeks. Participants’ report of pain, disability and their rating of recovery is also recorded by telephone interview at 6 months. Statistical analysis of between group differences will be performed with ANOVAs and MANOVAs, and multivariable regression analysis will be undertaken to explore predictor variables. Ethical approval for this study has been received from the Beaumont Hospital and Irish College of General Practitioners Research Ethics Committees. The trial is registered at ClinicalTrials.gov (NCT02449200). DISCUSSION: An internal pilot study to test retention and recruitment strategies led to trial expansion and this is now a multi centre trial involving 5 clinical sites. TRIAL REGISTRATION: NCT02449200. Registered 20/05/15. |
format | Online Article Text |
id | pubmed-6545204 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-65452042019-06-05 A randomised controlled trial of multimodal physiotherapy versus advice for recent onset, painful cervical radiculopathy – the PACeR trial protocol Keating, Louise Treanor, Caroline Sugrue, Julie Meldrum, Dara Bolger, Ciaran Doody, Catherine BMC Musculoskelet Disord Study Protocol BACKGROUND: A research gap exists for optimal management of cervical radiculopathy in the first 12 weeks and short term natural history of the condition is somewhat unclear, although thought to be favourable. The primary aim of this assessor blinded, superiority, 2 parallel group randomised controlled trial is to investigate the effects of a 4 week physiotherapy programme (6–8 sessions) of manual therapy, exercise and upper limb neural unloading tape, compared to a control of weekly phone advice; on disability, pain and selected biopsychosocial measures, in acute and sub-acute cervical radiculopathy patients. A secondary aim is to identify whether any baseline variables, symptom duration or group allocation can predict outcome. METHODS: Participants are recruited from GP referrals in an urban setting, from a neurosurgery non-urgent waiting list and from self-referral through Facebook advertising. Eligible participants (n = 64) are diagnosed with radiculopathy based on a clinical prediction rule and must have symptoms of unilateral, single level, radiculopathy for between 2 and 12 weeks, without having yet received physiotherapy. Random 1:1 group allocation (using variable block sizes), allocation concealment, blinded assessment and intention to treat analysis are being employed. Treatment is provided by clinical specialist physiotherapists in primary and secondary care settings. Outcomes are measured at baseline, 4 (primary endpoint) and 12 weeks. Participants’ report of pain, disability and their rating of recovery is also recorded by telephone interview at 6 months. Statistical analysis of between group differences will be performed with ANOVAs and MANOVAs, and multivariable regression analysis will be undertaken to explore predictor variables. Ethical approval for this study has been received from the Beaumont Hospital and Irish College of General Practitioners Research Ethics Committees. The trial is registered at ClinicalTrials.gov (NCT02449200). DISCUSSION: An internal pilot study to test retention and recruitment strategies led to trial expansion and this is now a multi centre trial involving 5 clinical sites. TRIAL REGISTRATION: NCT02449200. Registered 20/05/15. BioMed Central 2019-06-01 /pmc/articles/PMC6545204/ /pubmed/31153362 http://dx.doi.org/10.1186/s12891-019-2639-4 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Keating, Louise Treanor, Caroline Sugrue, Julie Meldrum, Dara Bolger, Ciaran Doody, Catherine A randomised controlled trial of multimodal physiotherapy versus advice for recent onset, painful cervical radiculopathy – the PACeR trial protocol |
title | A randomised controlled trial of multimodal physiotherapy versus advice for recent onset, painful cervical radiculopathy – the PACeR trial protocol |
title_full | A randomised controlled trial of multimodal physiotherapy versus advice for recent onset, painful cervical radiculopathy – the PACeR trial protocol |
title_fullStr | A randomised controlled trial of multimodal physiotherapy versus advice for recent onset, painful cervical radiculopathy – the PACeR trial protocol |
title_full_unstemmed | A randomised controlled trial of multimodal physiotherapy versus advice for recent onset, painful cervical radiculopathy – the PACeR trial protocol |
title_short | A randomised controlled trial of multimodal physiotherapy versus advice for recent onset, painful cervical radiculopathy – the PACeR trial protocol |
title_sort | randomised controlled trial of multimodal physiotherapy versus advice for recent onset, painful cervical radiculopathy – the pacer trial protocol |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6545204/ https://www.ncbi.nlm.nih.gov/pubmed/31153362 http://dx.doi.org/10.1186/s12891-019-2639-4 |
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