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Active behavioural physiotherapy intervention for acute non-specific neck pain: a cluster randomised double-blind pilot and feasibility clinical trial [with consumer summary] |
Wiangkham T, Uthaikhup S, Chidnok W, Rushton A |
Disability and Rehabilitation 2024;46(12):2558-2566 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: No; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
PURPOSE: To evaluate the feasibility of an active behavioural physiotherapy intervention (ABPI) and procedures to prevent the transition to chronicity in patients with acute non-specific neck pain (ANSNP). MATERIALS AND METHODS: A cluster-randomised double-blind (assessors and participants), parallel 2-arm (ABPI versus standard physiotherapy intervention (SPI)) pilot and feasibility clinical trial was conducted owing to a pre-specified published protocol. Six public hospitals were recruited and cluster-randomised (computer-generated randomisation with block sampling). Sixty participants (30 in each arm, 10 per hospital) were assessed at baseline and 3 months following baseline for neck disability index, numerical pain rating scale, cervical range-of-motion, fear-avoidance beliefs questionnaire and EuroQol 5-dimension 5-level. RESULTS: All procedures worked well. The participants' median age was 36.5 (range 21 to 59, interquartile range: 20.75) years. Participants in the ABPI demonstrated better improvement in all outcomes compared to SPI. Furthermore, the number of fully recovered participants following ABPI (27/30, 90.00%) was higher than SPI (16/30, 53.33%) with fewer treatment sessions and lower costs of management. CONCLUSIONS: The findings suggest that the ABPI is feasible and valuable (eg, a high number of fully recovered participants, fewer treatment sessions and reduced management costs compared to the SPI) in conducting a future definitive trial to evaluate the effectiveness of the ANSNP management. TRIAL REGISTRATION: TCTR20180607001
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