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虚拟现实瑜伽治疗慢性下腰痛的有效性:一项随机临床试验。

Effectiveness of Virtual Yoga for Chronic Low Back Pain: A Randomized Clinical Trial.

机构信息

Department of Wellness and Preventive Medicine, Primary Care Institute, Cleveland Clinic, Cleveland, Ohio.

Department of Internal Medicine, Primary Care Institute, Cleveland Clinic, Cleveland Ohio.

出版信息

JAMA Netw Open. 2024 Nov 4;7(11):e2442339. doi: 10.1001/jamanetworkopen.2024.42339.

Abstract

IMPORTANCE

Chronic low back pain (CLBP) is a common condition with substantial impact on patients, in the form of physical and emotional suffering; health care costs; productivity; and health care professional burden. Although clinical guidelines recommend use of nonpharmacologic treatments first, such as yoga, there is a gap between guidelines and implementation in clinical practice.

OBJECTIVE

To compare the effects of virtual yoga classes vs a wait-list control on CLBP intensity, back-related function, sleep quality, and pain medication use.

DESIGN, SETTING, AND PARTICIPANTS: Single-blinded, 24-week, 2-arm, randomized clinical trial conducted from May 3, 2022, through May 23, 2023, comparing live streamed yoga classes (the yoga now group) with a wait-list control (the yoga later group, in which participants were offered the virtual intervention after the study but without assessments) among adults with CLBP. Adults 18 to 64 years of age with CLBP were recruited from the Cleveland Clinic Employee Health Plan, a large health system self-insured health plan. Inclusion criteria included a mean LBP intensity score of at least 4 on an 11-point numerical rating scale (scores ranged from 0 to 10, with higher scores indicating worse pain) and daily back pain interference about half or more of the days.

INTERVENTION

Twelve consecutive weekly, 60-minute, virtual, live streamed hatha yoga group classes.

MAIN OUTCOMES AND MEASURES

Coprimary outcomes were mean pain intensity in the previous week on the 11-point numerical rating scale and back-related function as assessed using the 23-point modified Roland Morris Disability Questionnaire ([RMDQ], with higher scores reflecting poorer function) at 12 weeks. Secondary and exploratory outcomes included these measures at 24 weeks, pain medication use, and PROMIS sleep quality assessed using the Sleep Disturbance Short Form 8a, item 1 (scores ranged from 0 to 4, with higher scores reflecting better sleep quality). Analyses followed the intention-to-treat principle.

RESULTS

Among 140 participants enrolled (yoga now = 71; yoga later = 69), the mean (SD) age was 47.8 (11.7) years and most were female (113 [80.7%]) and college-educated (103 [73.5%]). Mean (SD) baseline pain intensity (5.7 [1.5]) and RMDQ ([12.1 [4.4]) scores reflected moderate back pain and impairment. At week 12, yoga now compared with yoga later had greater reductions in mean pain intensity (-1.5 [95% CI, -2.2 to -0.7] points; P < .001) and mean RMDQ (-2.8 [95% CI, -4.3 to -1.3] points; P < .001) scores. At 24 weeks, the improvements in pain (mean change, -2.3 [95% CI, -3.1 to -1.6] points; P < .001) and RMDQ (mean change, -4.6 [95% CI, -6.1 to -3.1] points; P < .001) scores were sustained. At 12 weeks, yoga now participants reported 21.4 (95% CI, 5.2-37.6) absolute percentage points less use of any analgesic medication during the past week than yoga later participants and at 24 weeks, 21.2 absolute percentage points (95% CI, 5.2%-37.3%). Improvements in sleep quality were greater for participants in yoga now than among participants in yoga later at 12 weeks (mean change, 0.4 [95% CI, 0.1-0.7] points; P = .008) and 24 weeks (mean change, 0.4 [95% CI, 0.1-0.7] points; P = .005).

CONCLUSIONS AND RELEVANCE

Results of this randomized clinical trial of 140 adults with CLBP who were members of a large health system self-insured health plan suggest that virtual yoga classes may be a feasible, safe, and effective treatment option.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT05319691.

摘要

重要性

慢性下腰痛 (CLBP) 是一种常见病症,会给患者带来身体和情感上的痛苦、医疗保健费用、生产力以及医疗保健专业人员的负担。尽管临床指南建议首先使用非药物治疗方法,如瑜伽,但在临床实践中,指南和实施之间存在差距。

目的

比较虚拟瑜伽课程与候补名单对照在 CLBP 强度、背部相关功能、睡眠质量和疼痛药物使用方面的效果。

设计、设置和参与者:一项单盲、24 周、2 臂随机临床试验,于 2022 年 5 月 3 日至 2023 年 5 月 23 日进行,比较了克利夫兰诊所员工健康计划中的成年人中实时直播瑜伽课程(瑜伽现在组)与候补名单对照(瑜伽后来组,研究后为参与者提供虚拟干预,但没有评估),参与者为 CLBP 成人。该健康计划是一个大型自我保险健康计划,纳入标准为平均 LBP 强度评分至少为 11 点数字评定量表上的 4 分(评分范围为 0 到 10,得分越高表示疼痛越严重),每日背部疼痛干扰约一半或更多天数。

干预措施

连续 12 周每周 60 分钟的虚拟实时直播哈他瑜伽小组课程。

主要结果和测量

主要结果是 11 点数字评定量表上过去一周的平均疼痛强度(12 周时为 23 点改良 Roland Morris 残疾问卷的背部相关功能)。次要和探索性结果包括这些测量在 24 周时、疼痛药物使用和使用睡眠障碍简短形式 8a 评估的 PROMIS 睡眠质量,第 1 项(评分范围为 0 到 4,得分越高表示睡眠质量越好)。分析遵循意向治疗原则。

结果

在 140 名入组的参与者中(瑜伽现在组=71;瑜伽后来组=69),平均(SD)年龄为 47.8(11.7)岁,大多数为女性(113[80.7%])和大学学历(103[73.5%])。平均(SD)基线疼痛强度(5.7[1.5])和 Roland Morris 残疾问卷([12.1[4.4])分数反映了中度背部疼痛和功能障碍。在第 12 周时,瑜伽现在组与瑜伽后来组相比,疼痛强度平均降低(-1.5[95%CI,-2.2 到-0.7]点;P<0.001)和 Roland Morris 残疾问卷平均降低(-2.8[95%CI,-4.3 到-1.3]点;P<0.001)。在第 24 周时,疼痛(平均变化,-2.3[95%CI,-3.1 到-1.6]点;P<0.001)和 Roland Morris 残疾问卷(平均变化,-4.6[95%CI,-6.1 到-3.1]点;P<0.001)的改善持续存在。在第 12 周时,瑜伽现在组参与者报告在过去一周中使用任何镇痛药的比例比瑜伽后来组参与者低 21.4%(95%CI,5.2%至 37.6%),在第 24 周时,低 21.2%(95%CI,5.2%至 37.3%)。与瑜伽后来组相比,瑜伽现在组参与者在第 12 周和第 24 周时的睡眠质量改善更大(12 周时平均变化,0.4[95%CI,0.1-0.7]点;P=0.008)和 0.4[95%CI,0.1-0.7]点;P=0.005)。

结论和相关性

这项针对 140 名 CLBP 成年人的随机临床试验结果表明,虚拟瑜伽课程可能是一种可行、安全且有效的治疗选择,这些参与者是一家大型自我保险健康计划的员工。

试验注册

ClinicalTrials.gov 标识符:NCT05319691。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c830/11530940/bcf2b11f3193/jamanetwopen-e2442339-g001.jpg

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