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参与慢性下腰痛针灸临床试验的老年受试者的既往针灸经历:对未来试验的启示

Prior acupuncture experience among elderly participants enrolled in a clinical trial of acupuncture for chronic low back pain: Implications for future trials.

作者信息

Wang Prince Ziyi, Pressman Alice, Sanchez Gabriela, Aparicio Crystal, Nielsen Arya, Avins Andrew

机构信息

Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, CA, USA.

Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.

出版信息

Integr Med Res. 2024 Jun;13(2):101042. doi: 10.1016/j.imr.2024.101042. Epub 2024 Apr 17.

Abstract

BACKGROUND

The effectiveness of acupuncture for chronic low back pain (cLBP) has not been studied specifically in the 65-and-older population. To inform the validity and generalizability of future acupuncture studies among older adults, we characterized elderly participants' prior experience with and views toward acupuncture and tested for clinical and sociodemographic differences between acupuncture-naïve and non-naïve participants.

METHODS

Data for this study were collected during the baseline telephone interview from the participants enrolled in the Kaiser Permanente Northern California site of an NIH-funded, multicenter clinical trial of acupuncture for cLBP in older adults.

RESULTS

Nearly two-thirds (65.6 %) of participants surveyed reported they had previously received acupuncture treatment with the vast majority seeking acupuncture treatment for pain-related issues (84.8 %). The majority of these participants reported relatively modest levels of exposure to acupuncture with most participants (63.1 %) reporting fewer than 10 treatment sessions over their lifetimes. There were no significant differences in age, sex, race, ethnicity, disability scores, income levels, or pain levels between the acupuncture-naïve and non-naïve groups.

CONCLUSION

Contextual consideration for prior acupuncture utilization rates is warranted and may be higher than expected or previously reported. We found few differences in baseline characteristics between participants who were acupuncture-naïve and those with prior acupuncture experience; thus, future pragmatic clinical trials might relax previous acupuncture-use considerations in their recruitment criteria. For trials focused on acupuncture-naive patients, it may be more feasible to expand the definition of "acupuncture-naive" based on lifetime acupuncture visits or time since last treatment.

TRIAL REGISTRATION

The protocol was registered at clinicaltrials.gov (#NCT04982315).

摘要

背景

针刺疗法治疗慢性下腰痛(cLBP)的有效性尚未在65岁及以上人群中进行专门研究。为了了解未来针对老年人的针刺疗法研究的有效性和普遍性,我们对老年参与者先前的针刺疗法体验和看法进行了特征分析,并测试了初次接受针刺治疗和非初次接受针刺治疗的参与者之间的临床和社会人口统计学差异。

方法

本研究的数据是在基线电话访谈期间收集的,访谈对象是参加美国国立卫生研究院资助的、针对老年人cLBP的针刺疗法多中心临床试验的北加利福尼亚凯撒医疗集团的参与者。

结果

近三分之二(65.6%)接受调查的参与者报告称他们之前接受过针刺治疗,绝大多数人寻求针刺治疗是为了解决与疼痛相关的问题(84.8%)。这些参与者中的大多数报告称接触针刺疗法的程度相对较低,大多数参与者(63.1%)报告称其一生中接受的治疗疗程少于10次。初次接受针刺治疗组和非初次接受针刺治疗组在年龄、性别、种族、民族、残疾评分、收入水平或疼痛程度方面没有显著差异。

结论

有必要对先前的针刺疗法使用率进行背景考量,其使用率可能高于预期或先前报告的水平。我们发现初次接受针刺治疗的参与者和有过针刺治疗经验的参与者在基线特征方面几乎没有差异;因此,未来务实的临床试验可能会在招募标准中放宽先前对针刺疗法使用情况的考量。对于专注于初次接受针刺治疗患者的试验,根据终生针刺治疗就诊次数或自上次治疗以来的时间来扩大“初次接受针刺治疗”的定义可能更可行。

试验注册

该方案已在clinicaltrials.gov(#NCT04982315)注册。

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