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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

      protocol

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          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.

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          Most cited references61

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          Design and analysis of pilot studies: recommendations for good practice.

          Susanna Dodd, G Lancaster, Paula Williamson … (2004)
          Pilot studies play an important role in health research, but they can be misused, mistreated and misrepresented. In this paper we focus on pilot studies that are used specifically to plan a randomized controlled trial (RCT). Citing examples from the literature, we provide a methodological framework in which to work, and discuss reasons why a pilot study might be undertaken. A well-conducted pilot study, giving a clear list of aims and objectives within a formal framework will encourage methodological rigour, ensure that the work is scientifically valid and publishable, and will lead to higher quality RCTs. It will also safeguard against pilot studies being conducted simply because of small numbers of available patients.
          Article 0 comments Cited 365 times – based on 0 reviews     Review now
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            A systematic review of the pain scales in adults: Which to use?

            Ozgur Dikme, Ozlem Dikme, Ozgur Karcioglu … (2018)
            The study analysed the Visual Analogue Scale (VAS), the Verbal Rating Scale (VRS) and the Numerical Rating Scale (NRS) to determine: 1. Were the compliance and usability different among scales? 2. Were any of the scales superior over the other(s) for clinical use?
            Article 0 comments Cited 223 times – based on 0 reviews     Review now
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              Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department.

              Matthew T Latimer, E. Gallagher, Polly Bijur (2003)
              Verbally administered numerical rating scales (NRSs) from 0 to 10 are often used to measure pain, but they have not been validated in the emergency department (ED) setting. The authors wished to assess the comparability of the NRS and visual analog scale (VAS) as measures of acute pain, and to identify the minimum clinically significant difference in pain that could be detected on the NRS. This was a prospective cohort study of a convenience sample of adults presenting with acute pain to an urban ED. Patients verbally rated pain intensity as an integer from 0 to 10 (0 = no pain, 10 = worst possible pain), and marked a 10-cm horizontal VAS bounded by these descriptors. VAS and NRS data were obtained at presentation, 30 minutes later, and 60 minutes later. At 30 and 60 minutes, patients were asked whether their pain was "much less," "a little less," "about the same," "a little more," or "much more." Differences between consecutive pairs of measurements on the VAS and NRS obtained at 30-minute intervals were calculated for each of the five categories of pain descriptor. The association between VAS and NRS scores was expressed as a correlation coefficient. The VAS scores were regressed on the NRS scores in order to assess the equivalence of the measures. The mean changes associated with descriptors "a little less" or "a little more" were combined to define the minimum clinically significant difference in pain measured on the VAS and NRS. Of 108 patients entered, 103 provided data at 30 minutes and 86 at 60 minutes. NRS scores were strongly correlated to VAS scores at all time periods (r = 0.94, 95% CI = 0.93 to 0.95). The slope of the regression line was 1.01 (95% CI = 0.97 to 1.06) and the y-intercept was -0.34 (95% CI = -0.67 to -0.01). The minimum clinically significant difference in pain was 1.3 (95% CI = 1.0 to 1.5) on the NRS and 1.4 (95% CI = 1.1 to 1.7) on the VAS. The findings suggest that the verbally administered NRS can be substituted for the VAS in acute pain measurement.
              Article 0 comments Cited 181 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMJ Open
                Journal ID (iso-abbrev): BMJ Open
                Journal ID (hwp): bmjopen
                Journal ID (publisher-id): bmjopen
                Title: BMJ Open
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Electronic): 2044-6055
                Publication date Collection: 2019
                Publication date (Electronic): 30 September 2019
                Volume: 9
                Issue: 9
                Electronic Location Identifier: e029795
                Affiliations
                [1 ] departmentExercise and Rehabilitation Sciences Research Unit, Faculty of Allied Health Sciences , Naresuan University , Phitsanulok, Thailand
                [2 ] departmentDepartment of Physical Therapy, Faculty of Allied Health Sciences , Naresuan University , Phitsanulok, Thailand
                [3 ] departmentDepartment of Physical Therapy, Faculty of Associated Medical Sciences , Chiang Mai University , Chiang Mai, Thailand
                [4 ] departmentCentre of Precision Rehabilitation for Spinal Pain (CPR Spine) , University of Birmingham , Birmingham, UK
                [5 ] departmentSchool of Sport, Exercise and Rehabilitation Sciences , University of Birmingham , Birmingham, UK
                Author notes
                [Correspondence to ] Dr Taweewat Wiangkham; taweewatw@ 123456nu.ac.th
                Author information
                http://orcid.org/0000-0003-4115-704X
                http://orcid.org/0000-0001-8114-7669
                Article
                Publisher ID: bmjopen-2019-029795
                DOI: 10.1136/bmjopen-2019-029795
                PMC ID: 6773360
                PubMed ID: 31575571
                SO-VID: 84c1bcfb-cc7d-4e01-aa4e-966cd3b6af62
                Copyright © © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
                License:

                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/.

                History
                Date received : 12 February 2019
                Date revision received : 08 August 2019
                Date accepted : 04 September 2019
                Funding
                Funded by: Thailand Research Fund;
                Award ID: Grant for New Scholar (MRG6180069)
                Categories
                Subject: Rehabilitation Medicine
                Subject: Protocol
                Subject: 1506
                Subject: 1727
                Custom metadata
                special-feature unlocked

                ScienceOpen disciplines: Medicine
                Keywords: non-specific neck pain,์neck pain,active behavioural physiotherapy intervention,complex intervention,pilot and feasibility trial,cluster randomisation
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: non-specific neck pain, ์neck pain, active behavioural physiotherapy intervention, complex intervention, pilot and feasibility trial, cluster randomisation

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