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
| Autor: | Alison Rushton, Sureeporn Uthaikhup, Taweewat Wiangkham |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Population cluster randomisation Disease cluster active behavioural physiotherapy intervention complex intervention Rehabilitation Medicine Non-specific neck pain Interviews as Topic 03 medical and health sciences Young Adult 0302 clinical medicine Double-Blind Method Rating scale ์Neck pain pilot and feasibility trial Behavior Therapy Intervention (counseling) Surveys and Questionnaires Pragmatic Clinical Trials as Topic Protocol Medicine Humans 030212 general & internal medicine education Physical Therapy Modalities Pain Measurement Randomized Controlled Trials as Topic education.field_of_study Neck pain Neck Pain Interpretative phenomenological analysis business.industry General Medicine Middle Aged Institutional review board Thailand Acute Pain Physical therapy Feasibility Studies Female medicine.symptom business 030217 neurology & neurosurgery Qualitative research |
| Zdroj: | BMJ Open |
| ISSN: | 2044-6055 |
| Popis: | IntroductionNon-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 analysisTwo 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 disseminationThis trial is approved by the Naresuan University Institutional Review Board (NUIRB_0380/61).Trial registration number and statusTCTR20180607001; Recruiting commenced 1 February 2019. |
| Databáze: | OpenAIRE |
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