Back2Action: effectiveness of physiotherapy blended with eHealth consisting of pain education and behavioural activation versus physiotherapy alone-protocol for a pragmatic randomised clinical trial for people with subacute or persistent spinal pain

Lisette Bijker; Leonore De Wit; Pim Cuijpers; Eva Poolman; Gwendolijne Scholten-Peeters; Michel W. Coppieters

doi:10.1136/bmjopen-2021-050808

Back2Action: effectiveness of physiotherapy blended with eHealth consisting of pain education and behavioural activation versus physiotherapy alone-protocol for a pragmatic randomised clinical trial for people with subacute or persistent spinal pain

Lisette Bijker, Leonore De Wit, Pim Cuijpers, Eva Poolman, Gwendolijne Scholten-Peeters, Michel W. Coppieters^*

^*Corresponding author for this work

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

INTRODUCTION: Psychosocial factors predict recovery in patients with spinal pain. Several of these factors are modifiable, such as depression and anxiety. However, primary care physiotherapists who typically manage these patients indicate that they do not feel sufficiently competent and equipped to address these factors optimally. We developed an eHealth intervention with a focus on pain education and behavioural activation to support physiotherapists in managing psychosocial factors in patients with spinal pain. This paper describes the protocol for a pragmatic randomised clinical trial, which evaluates the effectiveness of this eHealth intervention blended with physiotherapy compared with physiotherapy alone.

METHODS AND ANALYSIS: Participants with non-specific low back pain and/or neck pain for at least 6 weeks who also have psychosocial risk factors associated with the development or maintenance of persistent pain will be recruited in a pragmatic multicentre cluster randomised clinical trial. The experimental intervention consists of physiotherapy blended with six online modules of pain education and behavioural activation. The control intervention consists of usual care physiotherapy. The primary outcomes are disability (Oswestry Disability Index for low back pain and Neck Disability Index for neck pain) and perceived effect (Global Perceived Effect). Outcomes will be assessed at baseline and at 2, 6 and 12 months after baseline. The results will be analysed using linear mixed models.

ETHICS AND DISSEMINATION: The study is approved by the Medical Ethical Committee of VU Medical Center Amsterdam, The Netherlands (2017.286). Results will be reported in peer-reviewed journals, at national and international conferences, and in diverse media to share the findings with patients, clinicians and the public.

TRIAL REGISTRATION NUMBER: NL 5941; The Netherlands Trial Register.

Original language	English
Article number	e050808
Pages (from-to)	1-10
Number of pages	10
Journal	BMJ Open
Volume	12
Issue number	1
DOIs	https://doi.org/10.1136/bmjopen-2021-050808 https://doi.org/10.1136/bmjopen-2021-050808
Publication status	Published - 7 Jan 2022

Bibliographical note

Funding Information:
This work was supported by an internal grant from the Faculty of Behavioural- and Movement Sciences, Vrije Universiteit Amsterdam. Grant number is not applicable.

Publisher Copyright:
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords

digital health
disability
mental health
musculoskeletal health
rehabilitation

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Bijker, L., De Wit, L., Cuijpers, P., Poolman, E., Scholten-Peeters, G., & Coppieters, M. W. (2022). Back2Action: effectiveness of physiotherapy blended with eHealth consisting of pain education and behavioural activation versus physiotherapy alone-protocol for a pragmatic randomised clinical trial for people with subacute or persistent spinal pain. BMJ Open, 12(1), 1-10. Article e050808. https://doi.org/10.1136/bmjopen-2021-050808, https://doi.org/10.1136/bmjopen-2021-050808

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abstract = "INTRODUCTION: Psychosocial factors predict recovery in patients with spinal pain. Several of these factors are modifiable, such as depression and anxiety. However, primary care physiotherapists who typically manage these patients indicate that they do not feel sufficiently competent and equipped to address these factors optimally. We developed an eHealth intervention with a focus on pain education and behavioural activation to support physiotherapists in managing psychosocial factors in patients with spinal pain. This paper describes the protocol for a pragmatic randomised clinical trial, which evaluates the effectiveness of this eHealth intervention blended with physiotherapy compared with physiotherapy alone.METHODS AND ANALYSIS: Participants with non-specific low back pain and/or neck pain for at least 6 weeks who also have psychosocial risk factors associated with the development or maintenance of persistent pain will be recruited in a pragmatic multicentre cluster randomised clinical trial. The experimental intervention consists of physiotherapy blended with six online modules of pain education and behavioural activation. The control intervention consists of usual care physiotherapy. The primary outcomes are disability (Oswestry Disability Index for low back pain and Neck Disability Index for neck pain) and perceived effect (Global Perceived Effect). Outcomes will be assessed at baseline and at 2, 6 and 12 months after baseline. The results will be analysed using linear mixed models.ETHICS AND DISSEMINATION: The study is approved by the Medical Ethical Committee of VU Medical Center Amsterdam, The Netherlands (2017.286). Results will be reported in peer-reviewed journals, at national and international conferences, and in diverse media to share the findings with patients, clinicians and the public.TRIAL REGISTRATION NUMBER: NL 5941; The Netherlands Trial Register.",

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Bijker, L , De Wit, L , Cuijpers, P , Poolman, E , Scholten-Peeters, G & Coppieters, MW 2022, 'Back2Action: effectiveness of physiotherapy blended with eHealth consisting of pain education and behavioural activation versus physiotherapy alone-protocol for a pragmatic randomised clinical trial for people with subacute or persistent spinal pain', BMJ Open, vol. 12, no. 1, e050808, pp. 1-10. https://doi.org/10.1136/bmjopen-2021-050808, https://doi.org/10.1136/bmjopen-2021-050808

Back2Action: effectiveness of physiotherapy blended with eHealth consisting of pain education and behavioural activation versus physiotherapy alone-protocol for a pragmatic randomised clinical trial for people with subacute or persistent spinal pain. / Bijker, Lisette ; De Wit, Leonore ; Cuijpers, Pim et al.
In: BMJ Open, Vol. 12, No. 1, e050808, 07.01.2022, p. 1-10.

Research output: Contribution to Journal › Article › Academic › peer-review

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AU - De Wit, Leonore

AU - Cuijpers, Pim

AU - Poolman, Eva

AU - Scholten-Peeters, Gwendolijne

AU - Coppieters, Michel W.

N1 - Funding Information: This work was supported by an internal grant from the Faculty of Behavioural- and Movement Sciences, Vrije Universiteit Amsterdam. Grant number is not applicable. Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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Y1 - 2022/1/7

N2 - INTRODUCTION: Psychosocial factors predict recovery in patients with spinal pain. Several of these factors are modifiable, such as depression and anxiety. However, primary care physiotherapists who typically manage these patients indicate that they do not feel sufficiently competent and equipped to address these factors optimally. We developed an eHealth intervention with a focus on pain education and behavioural activation to support physiotherapists in managing psychosocial factors in patients with spinal pain. This paper describes the protocol for a pragmatic randomised clinical trial, which evaluates the effectiveness of this eHealth intervention blended with physiotherapy compared with physiotherapy alone.METHODS AND ANALYSIS: Participants with non-specific low back pain and/or neck pain for at least 6 weeks who also have psychosocial risk factors associated with the development or maintenance of persistent pain will be recruited in a pragmatic multicentre cluster randomised clinical trial. The experimental intervention consists of physiotherapy blended with six online modules of pain education and behavioural activation. The control intervention consists of usual care physiotherapy. The primary outcomes are disability (Oswestry Disability Index for low back pain and Neck Disability Index for neck pain) and perceived effect (Global Perceived Effect). Outcomes will be assessed at baseline and at 2, 6 and 12 months after baseline. The results will be analysed using linear mixed models.ETHICS AND DISSEMINATION: The study is approved by the Medical Ethical Committee of VU Medical Center Amsterdam, The Netherlands (2017.286). Results will be reported in peer-reviewed journals, at national and international conferences, and in diverse media to share the findings with patients, clinicians and the public.TRIAL REGISTRATION NUMBER: NL 5941; The Netherlands Trial Register.

AB - INTRODUCTION: Psychosocial factors predict recovery in patients with spinal pain. Several of these factors are modifiable, such as depression and anxiety. However, primary care physiotherapists who typically manage these patients indicate that they do not feel sufficiently competent and equipped to address these factors optimally. We developed an eHealth intervention with a focus on pain education and behavioural activation to support physiotherapists in managing psychosocial factors in patients with spinal pain. This paper describes the protocol for a pragmatic randomised clinical trial, which evaluates the effectiveness of this eHealth intervention blended with physiotherapy compared with physiotherapy alone.METHODS AND ANALYSIS: Participants with non-specific low back pain and/or neck pain for at least 6 weeks who also have psychosocial risk factors associated with the development or maintenance of persistent pain will be recruited in a pragmatic multicentre cluster randomised clinical trial. The experimental intervention consists of physiotherapy blended with six online modules of pain education and behavioural activation. The control intervention consists of usual care physiotherapy. The primary outcomes are disability (Oswestry Disability Index for low back pain and Neck Disability Index for neck pain) and perceived effect (Global Perceived Effect). Outcomes will be assessed at baseline and at 2, 6 and 12 months after baseline. The results will be analysed using linear mixed models.ETHICS AND DISSEMINATION: The study is approved by the Medical Ethical Committee of VU Medical Center Amsterdam, The Netherlands (2017.286). Results will be reported in peer-reviewed journals, at national and international conferences, and in diverse media to share the findings with patients, clinicians and the public.TRIAL REGISTRATION NUMBER: NL 5941; The Netherlands Trial Register.

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Bijker L , De Wit L , Cuijpers P , Poolman E , Scholten-Peeters G , Coppieters MW. Back2Action: effectiveness of physiotherapy blended with eHealth consisting of pain education and behavioural activation versus physiotherapy alone-protocol for a pragmatic randomised clinical trial for people with subacute or persistent spinal pain. BMJ Open. 2022 Jan 7;12(1):1-10. e050808. doi: 10.1136/bmjopen-2021-050808, 10.1136/bmjopen-2021-050808

Back2Action: effectiveness of physiotherapy blended with eHealth consisting of pain education and behavioural activation versus physiotherapy alone-protocol for a pragmatic randomised clinical trial for people with subacute or persistent spinal pain

Abstract

Bibliographical note

Keywords

Access to Document

Persistent URL (handle)

Other files and links

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Cite this