Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Keating, Louise, Treanor, Caroline, Sugrue, Julie, Meldrum, Dara, Bolger, Ciaran, Doody, Catherine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
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
_version_ 1783423351702683648
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
work_keys_str_mv AT keatinglouise arandomisedcontrolledtrialofmultimodalphysiotherapyversusadviceforrecentonsetpainfulcervicalradiculopathythepacertrialprotocol
AT treanorcaroline arandomisedcontrolledtrialofmultimodalphysiotherapyversusadviceforrecentonsetpainfulcervicalradiculopathythepacertrialprotocol
AT sugruejulie arandomisedcontrolledtrialofmultimodalphysiotherapyversusadviceforrecentonsetpainfulcervicalradiculopathythepacertrialprotocol
AT meldrumdara arandomisedcontrolledtrialofmultimodalphysiotherapyversusadviceforrecentonsetpainfulcervicalradiculopathythepacertrialprotocol
AT bolgerciaran arandomisedcontrolledtrialofmultimodalphysiotherapyversusadviceforrecentonsetpainfulcervicalradiculopathythepacertrialprotocol
AT doodycatherine arandomisedcontrolledtrialofmultimodalphysiotherapyversusadviceforrecentonsetpainfulcervicalradiculopathythepacertrialprotocol
AT keatinglouise randomisedcontrolledtrialofmultimodalphysiotherapyversusadviceforrecentonsetpainfulcervicalradiculopathythepacertrialprotocol
AT treanorcaroline randomisedcontrolledtrialofmultimodalphysiotherapyversusadviceforrecentonsetpainfulcervicalradiculopathythepacertrialprotocol
AT sugruejulie randomisedcontrolledtrialofmultimodalphysiotherapyversusadviceforrecentonsetpainfulcervicalradiculopathythepacertrialprotocol
AT meldrumdara randomisedcontrolledtrialofmultimodalphysiotherapyversusadviceforrecentonsetpainfulcervicalradiculopathythepacertrialprotocol
AT bolgerciaran randomisedcontrolledtrialofmultimodalphysiotherapyversusadviceforrecentonsetpainfulcervicalradiculopathythepacertrialprotocol
AT doodycatherine randomisedcontrolledtrialofmultimodalphysiotherapyversusadviceforrecentonsetpainfulcervicalradiculopathythepacertrialprotocol