Article Text

Assessing safety and treatment efficacy of running on intervertebral discs (ASTEROID) in adults with chronic low back pain: protocol for a randomised controlled trial
  1. Scott D Tagliaferri1,
  2. Daniel L Belavy2,
  3. Steven J Bowe3,4,
  4. Matthew J Clarkson5,
  5. David Connell6,
  6. Emma A Craige7,
  7. Romina Gollan8,
  8. Luana C Main1,
  9. Clint T Miller1,
  10. Ulrike H Mitchell9,
  11. Niamh L Mundell1,
  12. Christopher Neason1,
  13. Claire L Samanna1,
  14. David Scott1,10,
  15. Jamie L Tait1,
  16. Grace E Vincent11,
  17. Patrick J Owen1
  1. 1Deakin University, Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Geelong, Victoria, Australia
  2. 2Hochschule für Gesundheit (University of Applied Sciences), Department of Applied Health Sciences, Division of Physiotherapy, Gesundheitscampus 6-8, 44801, Bochum, Germany
  3. 3Deakin University, Biostatistics Unit, Faculty of Health, Geelong, Victoria, Australia
  4. 4Victoria University of Wellington, Wellington, New Zealand
  5. 5Institute for Health and Sport, Victoria University, Melbourne, Victoria, Australia
  6. 6Imaging @ Olympic Park, AAMI Park, 60 Olympic Boulevard, Melbourne, Victoria, Australia
  7. 7Medical and Applied Sciences, Central Queensland University, Rockhampton, Queensland, Australia
  8. 8Medical Psychology, Neuropsychology and Gender Studies & Center for Neuropsychological Diagnostics and Intervention (CeNDI), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany
  9. 9Department of Exercise Sciences, Brigham Young University, Provo, Utah, USA
  10. 10School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia
  11. 11Appleton Institute, School of Health, Medical and Applied Sciences, Central Queensland University, Adelaide, South Australia, Australia
  1. Correspondence to Dr Patrick J Owen; p.owen{at}deakin.edu.au

Abstract

Poor intervertebral disc (IVD) health is associated with low back pain (LBP). This 12-week parallel randomised controlled trial will evaluate the efficacy of a progressive interval running programme on IVD health and other clinical outcomes in adults with chronic LBP. Participants will be randomised to either a digitally delivered progressive interval running programme or waitlist control. Participants randomised to the running programme will receive three individually tailored 30 min community-based sessions per week over 12 weeks. The waitlist control will undergo no formal intervention. All participants will be assessed at baseline, 6 and 12 weeks. Primary outcomes are IVD health (lumbar IVD T2 via MRI), average LBP intensity over the prior week (100-point visual analogue scale) and disability (Oswestry Disability Index). Secondary outcomes include a range of clinical measures. All outcomes will be analysed using linear mixed models. This study has received ethical approval from the Deakin University Human Research Ethics Committee (ID: 2022-162). All participants will provide informed written consent before participation. Regardless of the results, the findings of this study will be disseminated, and anonymised data will be shared via an online repository. This will be the first study to evaluate whether a progressive interval running programme can improve IVD health in adults with chronic LBP. Identifying conservative options to improve IVD health in this susceptible population group has the potential to markedly reduce the burden of disease. This study was registered via the Australian New Zealand Clinical Trials Registry on 29 September 2022 (ACTRN12622001276741).

  • physical therapy
  • physiotherapy
  • MRI
  • physical activity
  • spine

Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study. Protocol only.

https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study. Protocol only.

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Footnotes

  • Twitter @ScottTags, @belavyprof, @mattjclarkson, @Emma_Craige, @RomyGollan, @_clintmiller, @NiamhMundell, @chris_neason, @ClaireLSamanna, @DavidScottPhD, @JamieTaitPhD, @PhDSleepy, @PatrickOwenPhD

  • Contributors Conceptualisation: SDT, DLB, UHM and PJO. Data curation: not applicable. Formal analysis: not applicable. Funding acquisition: DLB, SJB, LCM, CTM, UHM, DS, JLT and PJO. Investigation: not applicable. Methodology: all authors. Project administration: SDT, RG, CLS, CN and PJO. Resources: DC and PJO. Software: not applicable. Supervision: LCM, CTM, DS, JLT, GEV and PJO. Validation: not applicable. Visualization: not applicable. Writing—original draft: SDT and PJO. Writing—review & editing: all authors. Approved final manuscript: all authors.

  • Funding This work was supported by internal funding (Deakin University).

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.