虚拟瑜伽对慢性腰痛的疗效:随机临床试验。

IF 10.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL JAMA Network Open Pub Date : 2024-11-04 DOI:10.1001/jamanetworkopen.2024.42339
Hallie Tankha, Devyn Gaskins, Amanda Shallcross, Michael Rothberg, Bo Hu, Ning Guo, Eric J Roseen, Stephen Dombrowski, Judi Bar, Renee Warren, Holly Wilgus, Piper Tate, Johanna Goldfarb, Victoria Garcia Drago, Robert Saper
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引用次数: 0

摘要

重要性:慢性腰背痛(CLBP)是一种常见疾病,对患者的身体和精神痛苦、医疗费用、工作效率以及医护人员的负担都有很大影响。尽管临床指南建议首先使用瑜伽等非药物疗法,但指南与临床实践的实施之间存在差距:目的:比较虚拟瑜伽课程与候补对照组对慢性前列腺炎强度、背部相关功能、睡眠质量和疼痛药物使用的影响:从 2022 年 5 月 3 日至 2023 年 5 月 23 日进行的单盲、为期 24 周的双臂随机临床试验,在患有 CLBP 的成人中比较直播流瑜伽课程(现在瑜伽组)与等待名单对照组(以后瑜伽组,参与者在研究结束后可获得虚拟干预,但不进行评估)。患有慢性阻塞性肺病的 18 至 64 岁成年人是从克利夫兰诊所员工健康计划(一家大型医疗系统自保健康计划)中招募的。纳入标准包括在 11 点数字评分量表中枸杞多糖疼痛强度平均得分至少为 4 分(得分范围为 0 至 10 分,得分越高表示疼痛越严重),且每天有一半或更多的时间受到背部疼痛的干扰:主要结果和测量指标:主要结果:主要结果是前一周的平均疼痛强度(采用 11 点数字评分量表)和 12 周时与背部相关的功能(采用 23 点改良罗兰-莫里斯残疾问卷([RMDQ],分数越高表示功能越差)进行评估)。次要和探索性结果包括:24周时的上述测量结果、止痛药使用情况,以及使用睡眠紊乱简表8a第1项评估的PROMIS睡眠质量(得分范围为0至4分,得分越高反映睡眠质量越好)。分析遵循意向治疗原则:在 140 名参加者中(现在练习瑜伽 = 71 人;之后练习瑜伽 = 69 人),平均(标清)年龄为 47.8(11.7)岁,大多数为女性(113 人 [80.7%])和受过大学教育的女性(103 人 [73.5%])。平均(标清)基线疼痛强度(5.7 [1.5])和 RMDQ([12.1 [4.4]])评分反映了中度背痛和损伤。第 12 周时,现在练瑜伽与之后练瑜伽相比,平均疼痛强度降低幅度更大(-1.5 [95% CI, -2.2 to -0.7]分;P 结论与意义:这项随机临床试验的结果表明,虚拟瑜伽课程可能是一种可行、安全且有效的治疗方案:试验注册:ClinicalTrials.gov Identifier:试验注册:ClinicalTrials.gov Identifier:NCT05319691。
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Effectiveness of Virtual Yoga for Chronic Low Back Pain: A Randomized Clinical Trial.

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.

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来源期刊
JAMA Network Open
JAMA Network Open Medicine-General Medicine
CiteScore
16.00
自引率
2.90%
发文量
2126
审稿时长
16 weeks
期刊介绍: JAMA Network Open, a member of the esteemed JAMA Network, stands as an international, peer-reviewed, open-access general medical journal.The publication is dedicated to disseminating research across various health disciplines and countries, encompassing clinical care, innovation in health care, health policy, and global health. JAMA Network Open caters to clinicians, investigators, and policymakers, providing a platform for valuable insights and advancements in the medical field. As part of the JAMA Network, a consortium of peer-reviewed general medical and specialty publications, JAMA Network Open contributes to the collective knowledge and understanding within the medical community.
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