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  • Pragmatic cluster randomised double-blind pilot and feasibility trial of an active behavioural physiotherapy intervention for acute non-specific neck pain: a mixed-methods protocol

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Rehabilitation medicine
Protocol
Pragmatic cluster randomised double-blind pilot and feasibility trial of an active behavioural physiotherapy intervention for acute non-specific neck pain: a mixed-methods protocol
  1. Taweewat Wiangkham1,2,
  2. Sureeporn Uthaikhup3,
  3. Alison B Rushton4,5
  1. 1 Exercise and Rehabilitation Sciences Research Unit, Faculty of Allied Health Sciences, Naresuan University, Phitsanulok, Thailand
  2. 2 Department of Physical Therapy, Faculty of Allied Health Sciences, Naresuan University, Phitsanulok, Thailand
  3. 3 Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand
  4. 4 Centre of Precision Rehabilitation for Spinal Pain (CPR Spine), University of Birmingham, Birmingham, UK
  5. 5 School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK
  1. Correspondence to Dr Taweewat Wiangkham; taweewatw{at}nu.ac.th

Abstract

Introduction Non-specific neck pain causes pain and disability and contributes substantial socioeconomic burden internationally. Up to 50% of adults experience neck pain annually, leading to reduced the quality of life. An active behavioural physiotherapy intervention (ABPI) may be feasible to manage patients with acute non-specific neck pain to prevent transition to chronicity. A recent pilot and feasibility trial investigating an acute whiplash-associated disorder population found potential value of the ABPI with 95% of participants fully recovered (Neck Disability Index: NDI ≤4, compared with 17% in the standard physiotherapy arm); supporting a definitive trial. Qualitative findings from the physiotherapists supported the potential of the ABPI in a non-specific neck pain population.

Methods and analysis Two phases: (1) Pragmatic cluster randomised double-blind, parallel 2-arm (ABPI vs standard physiotherapy intervention) pilot and feasibility trial to evaluate the procedures and feasibility of the ABPI for the management of acute non-specific neck pain. Six physiotherapy departments from six public hospitals in Thailand will be recruited and cluster randomised by a computer-generated randomisation sequence with block sampling. Sixty participants (30 each arm, 10 per hospital) will be assessed at baseline and 3 months following baseline for NDI, Numerical Rating Scale for pain intensity, cervical range of motion, fear-avoidance beliefs questionnaire and EuroQol-5 dimensions 5 levels outcomes, and (2) Embedded qualitative study using semistructured interviews to explore acceptability of the ABPI to participants (n=12) and physiotherapists (n=3). Descriptive analysis of the quantitative data and interpretative phenomenological analysis to code and analyse qualitative data (deductive and inductive) will inform feasibility for a future definitive trial.

Ethics and dissemination This trial is approved by the Naresuan University Institutional Review Board (NUIRB_0380/61).

Trial registration number and status TCTR20180607001; Recruiting commenced 1 February 2019.

  • Non-specific neck pain
  • ์Neck pain
  • active behavioural physiotherapy intervention
  • complex intervention
  • pilot and feasibility trial
  • cluster randomisation

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-029795

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    Footnotes

    • Contributors TW is the chief investigator and guarantor leading to drafting the initial manuscript, protocol development, analyses and dissemination. TW, SU and ABR contributed to clinical and methodological decisions to ensure the trial quality and will contribute to data interpretation, conclusions and dissemination. All authors read and agreed the final manuscript.

    • Funding The trial is funded by the Thailand Research Fund (grant number: MRG6180069). The authors thank the Naresuan University and University of Birmingham for the sponsorship.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval The trial will be conducted in accordance with the Declaration of Helsinki and the ethical guidelines for medical human research and is approved by the Naresuan University Institutional Review Board (NUIRB_0380/61).

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