Hurley Deirdre A, O'Donoghue Grainne, Tully Mark A, Moffett Jennifer Klaber, van Mechelen Willem, Daly Leslie, Boreham Colin Ag, McDonough Suzanne M
School of Physiotherapy & Performance Science, University College Dublin, Dublin 4, Ireland.
BMC Musculoskelet Disord. 2009 Jul 2;10:79. doi: 10.1186/1471-2474-10-79.
Chronic low back pain (CLBP) is a persistent disabling condition with rising significant healthcare, social and economic costs. Current research supports the use of exercise-based treatment approaches that encourage people with CLBP to assume a physically active role in their recovery. While international clinical guidelines and systematic reviews for CLBP support supervised group exercise as an attractive first-line option for treating large numbers of CLBP patients at low cost, barriers to their delivery include space and time restrictions in healthcare settings and poor patient attendance. The European Clinical Guidelines have identified the need for research in the use of brief/minimal contact self-activation interventions that encourage participation in physical activity for CLBP. Walking may be an ideally suited form of individualized exercise prescription as it is easy to do, requires no special skills or facilities, and is achievable by virtually all ages with little risk of injury, but its effectiveness for LBP is unproven.
This study will be an assessor-blinded randomized controlled trial that will investigate the difference in clinical effectiveness and costs of an individualized walking programme and a supervised general exercise programme compared to usual physiotherapy, which will act as the control group, in people with chronic low back pain. A sample of 246 patients will be recruited in Dublin, Ireland through acute general hospital outpatient physiotherapy departments that provide treatment for people with CLBP. Patients will be randomly allocated to one of the three groups in a concealed manner. The main outcomes will be functional disability, pain, quality of life, fear avoidance, back beliefs, physical activity, satisfaction and costs, which will be evaluated at baseline, and 3, 6 and 12 months [follow-up by pre-paid postage]. Qualitative telephone interviews and focus groups will be embedded in the research design to obtain feedback about participants' experiences of the interventions and trial participation, and to inform interpretation of the quantitative data. Planned analysis will be by intention to treat (quantitative data) and thematic analysis (qualitative data)
The trial will evaluate the effectiveness of a walking programme and a supervised general exercise programme compared to usual physiotherapy in people with CLBP.
Current controlled trial ISRCTN17592092.
慢性下腰痛(CLBP)是一种持续性致残疾病,医疗、社会和经济成本不断攀升。目前的研究支持采用基于运动的治疗方法,鼓励CLBP患者在康复过程中积极参与体育活动。虽然国际CLBP临床指南和系统评价支持有监督的团体运动作为以低成本治疗大量CLBP患者的有吸引力的一线选择,但其实施障碍包括医疗环境中的空间和时间限制以及患者出勤率低。欧洲临床指南已确定需要研究使用简短/最少接触的自我激活干预措施,以鼓励CLBP患者参与体育活动。步行可能是一种理想的个性化运动处方形式,因为它易于进行,不需要特殊技能或设施,几乎所有年龄段的人都可以做到,受伤风险很小,但其对腰痛的有效性尚未得到证实。
本研究将是一项评估者盲法随机对照试验,将调查与作为对照组的常规物理治疗相比,个性化步行计划和有监督的一般运动计划在慢性下腰痛患者中的临床效果和成本差异。将通过为CLBP患者提供治疗的急性综合医院门诊物理治疗部门在爱尔兰都柏林招募246名患者。患者将以隐蔽的方式随机分配到三组中的一组。主要结局将是功能障碍、疼痛、生活质量、恐惧回避、背部信念、体育活动、满意度和成本,将在基线以及3、6和12个月时进行评估[通过预付邮资进行随访]。定性电话访谈和焦点小组将纳入研究设计,以获取参与者对干预措施和试验参与体验的反馈,并为定量数据的解释提供信息。计划分析将采用意向性分析(定量数据)和主题分析(定性数据)
该试验将评估与常规物理治疗相比,步行计划和有监督的一般运动计划在CLBP患者中的有效性。
当前对照试验ISRCTN17592092。