Brady Bernadette, Veljanova Irena, Schabrun Siobhan, Chipchase Lucinda
Departments of Pain Medicine and Physiotherapy, Liverpool Hospital, Liverpool, New South Wales, Australia.
School of Science and Health, Western Sydney University, Campbelltown, New South Wales, Australia.
BMJ Open. 2017 May 12;7(5):e014449. doi: 10.1136/bmjopen-2016-014449.
There is strong evidence that biopsychosocial approaches are efficacious in the management of chronic pain. However, implementation of these approaches in clinical practice is known not to account for the beliefs and values of culturally and linguistically diverse (CALD) patients. This limitation in translation of research contributes to the disparities in outcomes for CALD patients with chronic pain adding to the socioeconomic burden of this prevalent condition. Cultural adaptation of chronic pain assessment and management is urgently required. Thus, the aim of this pilot randomised controlled trial (RCT) is to determine the feasibility, participant acceptance with and clinical effectiveness of a culturally adapted physiotherapy assessment and treatment approach when contrasted with 'usual evidence based physiotherapy care' for three CALD communities.
Using a participant-blinded and assessor-blinded randomised controlled pilot design, patients with chronic pain who self-identify as Assyrian, Mandaean or Vietnamese will be randomised to either 'culturally adapted physiotherapy assessment and treatment' or 'evidence informed usual physiotherapy care'. We will recruit 16 participants from each ethnocultural community that will give a total of 24 participants in each treatment arm. Both groups will receive physiotherapy treatment for up to 10 sessions over 3 months. Outcomes including feasibility data, acceptance with the culturally adapted intervention, functional and pain-related measures will be collected at baseline and 3 months by a blinded assessor. Analysis will be descriptive for feasibility outcomes, while measures for clinical effectiveness will be explored using independent samples t-tests and repeated measures analysis of variance. This analysis will inform sample size estimates while also allowing for identification of revisions in the protocol or intervention prior to a larger scale RCT.
This trial has full ethical approval (HREC/16/LPOOL/194). The results from this pilot RCT will be presented at scientific meetings and published in peer-reviewed journals.
ACTRN12616000857404.
有充分证据表明，生物心理社会方法在慢性疼痛管理中是有效的。然而，在临床实践中实施这些方法时，并未考虑到文化和语言背景各异（CALD）患者的信仰和价值观。研究转化中的这一局限性导致CALD慢性疼痛患者的治疗结果存在差异，加重了这种普遍疾病的社会经济负担。迫切需要对慢性疼痛评估和管理进行文化调适。因此，这项初步随机对照试验（RCT）的目的是，对比针对三个CALD社区的“常规循证物理治疗护理”，确定一种经过文化调适的物理治疗评估和治疗方法的可行性、参与者接受度及临床效果。
采用参与者和评估者双盲的随机对照试验设计，自我认定为亚述人、曼达安人或越南人的慢性疼痛患者将被随机分为“经过文化调适的物理治疗评估和治疗”组或“循证常规物理治疗护理”组。我们将从每个种族文化社区招募16名参与者，每个治疗组共24名参与者。两组都将接受为期3个月、最多10次的物理治疗。包括可行性数据、对经过文化调适的干预措施的接受度、功能和疼痛相关指标等结果，将由一名盲态评估者在基线和3个月时收集。对可行性结果的分析将采用描述性方法，而临床效果的评估将使用独立样本t检验和重复测量方差分析。该分析将为样本量估计提供依据，同时也有助于在更大规模的RCT之前确定方案或干预措施的修订内容。
本试验已获得全面伦理批准（HREC/16/LPOOL/194）。这项初步RCT的结果将在科学会议上公布，并发表在同行评审期刊上。
ACTRN12616000857404。
