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《髋关节手法治疗与强化(MASH)试验:一项针对慢性腰背和髋部疼痛老年亚组患者的多中心随机试验方案》。

The Manual Therapy and Strengthening for the Hip (MASH) Trial: Protocol for a Multisite Randomized Trial of a Subgroup of Older Adults With Chronic Back and Hip Pain.

机构信息

Department of Physical Therapy, University of Delaware, Newark, Delaware, USA.

Clinical and Translational Sciences Institute, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania USA.

出版信息

Phys Ther. 2022 Jan 1;102(1). doi: 10.1093/ptj/pzab255.

Abstract

OBJECTIVE

Chronic low back pain (CLBP) is a disabling and costly condition for older adults that is difficult to properly classify and treat. In a cohort study, a subgroup of older adults with CLBP who had elevated hip pain and hip muscle weakness was identified; this subgroup differentiated itself by being at higher risk for future mobility decline. The primary purpose of this clinical trial is to evaluate whether a hip-focused low back pain (LBP) treatment provides better disability and physical performance outcomes for this at-risk group compared with a spine-focused LBP treatment.

METHODS

This study is a multisite, single-blinded, randomized controlled, parallel arm, Phase II trial conducted across 3 clinical research sites. A total of 180 people aged between 60 and 85 years with CLBP and hip pain are being recruited. Participants undergo a comprehensive baseline assessment and are randomized into 1 of 2 intervention arms: hip-focused or spine-focused. They are treated twice weekly by a licensed physical therapist for 8 weeks and undergo follow-up assessments at 8 weeks and 6 months after randomization. Primary outcome measures include the Quebec Low Back Disability Scale and the 10-Meter Walk Test, which are measures of self-report and performance-based physical function, respectively.

IMPACT

This multicenter, randomized clinical trial will determine whether a hip-focused or spine-focused physical therapist intervention results in improved disability and physical performance for a subgroup of older adults with CLBP and hip pain who are at increased risk of mobility decline. This trial will help further the development of effective interventions for this subgroup of older adults with CLBP.

摘要

目的

慢性下腰痛(CLBP)是一种使老年人丧失能力且代价高昂的疾病,难以进行正确的分类和治疗。在一项队列研究中,确定了 CLBP 伴髋关节疼痛和髋肌无力的老年人亚组;该亚组具有更高的未来活动能力下降风险,因此将其与其他患者区分开来。本临床试验的主要目的是评估针对髋关节的下腰痛(LBP)治疗是否能为该高风险人群提供更好的残疾和身体机能结果,与针对脊柱的 LBP 治疗相比。

方法

这是一项多地点、单盲、随机对照、平行臂、二期临床试验,在 3 个临床研究地点进行。共招募了 180 名年龄在 60 至 85 岁之间的慢性下腰痛和髋关节疼痛的患者。参与者接受全面的基线评估,并随机分为 2 个干预组之一:髋关节或脊柱焦点。他们由持照物理治疗师每周治疗两次,持续 8 周,并在随机分组后 8 周和 6 个月进行随访评估。主要结局指标包括魁北克下腰痛残疾量表和 10 米步行测试,分别衡量自我报告和基于表现的身体功能。

影响

这项多中心、随机临床试验将确定针对髋关节或脊柱的物理治疗师干预是否能改善髋关节疼痛且有更高活动能力下降风险的 CLBP 老年患者亚组的残疾和身体机能。该试验将有助于为 CLBP 老年患者亚组开发更有效的干预措施。

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