个体化针刺治疗慢性颈痛的长期疗效：一项随机对照试验。

Long-Term Effects of Individualized Acupuncture for Chronic Neck Pain : A Randomized Controlled Trial.

机构信息

Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China (L.Z., M.S., Z.Y., G.G., J.Chen, D.C., H.Z., F.L.).

Acupuncture and Tuina School, Guizhou University of Traditional Chinese Medicine, Guiyang, Guizhou, China (J.Cui).

出版信息

Ann Intern Med. 2024 Oct;177(10):1330-1338. doi: 10.7326/M23-2425. Epub 2024 Sep 3.

DOI:10.7326/M23-2425

PMID:39222507

Abstract

BACKGROUND

Long-term effects of individualized acupuncture in persons with chronic neck pain (CNP) remain unknown.

OBJECTIVE

To evaluate the efficacy and safety of pressure pain, sensory-based individualized acupuncture for relieving CNP.

DESIGN

A 24-week multicenter randomized controlled clinical trial. (ChiCTR1800016371).

SETTING

Outpatient settings at 4 clinical centers in China from May 2018 to March 2020.

PARTICIPANTS

716 participants with CNP.

INTERVENTION

Participants were randomly assigned to a waiting list (WL) group or to 1 of 3 interventions, which consisted of 10 sessions over 4 weeks: higher sensitive acupoints (HSA), lower sensitive acupoints (LSA), and sham acupoints (SA) acupuncture groups.

MEASUREMENTS

The primary outcome was the change in the visual analogue scale (VAS) score for neck pain (range, 0 to 100) from baseline to 4 weeks, with a difference of 10 points considered the minimum clinically important threshold. The VAS was also assessed every 4 weeks through 24 weeks.

RESULTS

The modified intention-to-treat population included 683 participants. The mean baseline VAS was 50.36, 50.10, 49.24, and 49.16 for HSA, LSA, SA, and WL, respectively. Compared with a mean baseline to week 4 change of -12.16 in the HSA group, the mean changes were -10.19 in the LSA group (net difference [ND], -1.97 [95% CI, -5.03 to 1.09]), -6.11 in the SA group (ND, -6.05 [CI, -9.10 to -3.00]), and -2.24 in the WL group (ND, -9.93 [CI, -12.95 to -6.90]). The intervention effects persisted at 24-week follow-up.

LIMITATION

Lack of complete blinding and limited generalizability.

CONCLUSION

Individualized acupuncture interventions using high- or low-sensitivity acupuncture points were more effective in reducing CNP than SA and WL control groups sustained through 24 weeks, but the magnitude of relative improvement did not reach a minimal clinically important difference.

PRIMARY FUNDING SOURCE

National Natural Science Foundation of China.

摘要

背景

长期个体化针灸对慢性颈痛（CNP）患者的影响尚不清楚。

目的

评估压力疼痛、基于感觉的个体化针灸缓解 CNP 的疗效和安全性。

设计

24 周多中心随机对照临床试验（ChiCTR1800016371）。

地点

中国 4 个临床中心的门诊，2018 年 5 月至 2020 年 3 月。

参与者

716 名 CNP 患者。

干预措施

参与者被随机分配到等待名单（WL）组或 3 种干预措施之一，包括 4 周内的 10 次治疗：高敏感穴位（HSA）、低敏感穴位（LSA）和假穴位（SA）针刺组。

测量

主要结局是从基线到 4 周时颈痛视觉模拟量表（VAS）评分的变化（范围 0 到 100），10 分的差异被认为是最小临床重要阈值。VAS 也在 24 周内每 4 周评估一次。

结果

修改后的意向治疗人群包括 683 名参与者。HSA、LSA、SA 和 WL 组的平均基线 VAS 分别为 50.36、50.10、49.24 和 49.16。与 HSA 组从基线到第 4 周的平均变化-12.16 相比，LSA 组的平均变化为-10.19（净差值[ND]，-1.97[95%CI，-5.03 至 1.09]），SA 组为-6.11（ND，-6.05[CI，-9.10 至-3.00]），WL 组为-2.24（ND，-9.93[CI，-12.95 至-6.90]）。干预效果在 24 周随访时持续存在。