The University of Sydney, Faculty of Medicine and Health, Sydney, NSW, 2006, Australia.
Chiropr Man Therap. 2020 Nov 18;28(1):61. doi: 10.1186/s12998-020-00348-z.
Pilot randomized controlled trial.
Better understanding of the relative effectiveness of different approaches to cervical spine mobilization has been identified as a research priority in manual therapy practice. Two distinct approaches to the practice of mobilization have emerged in recent years, based on different reasoning models for selection of mobilization techniques. The objective of this pilot study was to assess feasibility aspects for a future randomized clinical trial by exploring short-term pain and disability outcomes after a single treatment with pragmatic versus prescriptive approaches to cervical mobilization for people with recent-onset neck pain at 48-h follow-up after randomization.
Twenty adults with a new episode of mechanical neck pain were randomly allocated to either pragmatic or prescriptive mobilization intervention groups. The pragmatic group received a single treatment of cervical mobilization with the technique, target segment, and grade selected by their treating therapist. The prescriptive group received a single treatment of standardized mobilization with techniques similar to a previous mobilization clinical trial. Feasibility outcomes were recruitment rates, randomization audit and completion of treatment and follow-up per protocol. The primary clinical outcome of interest was disability level measured at 48-h follow-up after randomization.
Recruitment rates were approximately 2.5 participants per week and 100% of eligible participants were deemed suitable for treatment with cervical mobilization. There was sufficient variety in the range of pragmatic treatments selected and the data collection process imposed minimal burden on participants.
Our results provide supporting evidence for the feasibility of a future larger scale randomized clinical trial.
Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12616000446460). Registered 6th April 2016. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370448&isReview=true.
先导随机对照试验。
更好地了解不同颈椎活动方法的相对有效性已被确定为手法治疗实践中的研究重点。近年来，基于选择活动技术的不同推理模型，出现了两种截然不同的活动实践方法。本先导研究的目的是通过探索随机分组后 48 小时随访时， 采用实用与规范两种方法治疗新发颈痛患者单次治疗的短期疼痛和残疾结局，评估未来随机临床试验的可行性方面。
20 名新发机械性颈痛患者被随机分配到实用或规范的颈椎活动干预组。实用组接受其治疗师选择的技术、目标节段和等级的单次颈椎活动治疗。规范组接受与以前的活动临床试验相似的标准化活动治疗。可行性结局是招募率、随机审计和按方案完成治疗和随访。主要临床结局是随机分组后 48 小时随访时的残疾水平。
招募率约为每周 2.5 人，100%符合条件的参与者适合接受颈椎活动治疗。实用治疗方法的选择范围足够多样化，数据收集过程对参与者的负担最小。
我们的结果为未来更大规模的随机临床试验的可行性提供了支持证据。
澳大利亚新西兰临床试验注册中心（ACTRN12616000446460）。于 2016 年 4 月 6 日注册。https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370448&isReview=true。
