耳针治疗妊娠相关下腰痛和骨盆后带疼痛的效果：一项多中心随机临床试验。

Effect of ear acupuncture on pregnancy-related pain in the lower back and posterior pelvic girdle: A multicenter randomized clinical trial.

机构信息

Pain Treatment Unit, Doña Mercedes Primary Health Care Center, Dos Hermanas, Spain.

Hospital Valle Del Guadalhorce, Pizarra, Málaga, Spain.

出版信息

Acta Obstet Gynecol Scand. 2019 Oct;98(10):1307-1317. doi: 10.1111/aogs.13635. Epub 2019 Jun 1.

DOI:10.1111/aogs.13635

PMID:31034580

Abstract

INTRODUCTION

Ear acupuncture carried out in primary care by trained midwives, with no specialist training in acupuncture, may be effective in alleviating pregnancy-related lower back and/or posterior pelvic girdle pain (LBPGP). The objective of this study was to assess the effect of ear acupuncture associated with standard obstetric care, in the primary-care setting, on LBPGP experienced by pregnant women.

MATERIAL AND METHODS

This four-group, multicenter, randomized controlled trial was conducted at 18 public primary care centers in three regions in Spain, with the participation of 220 pregnant women at 24-36 weeks of gestation, aged 18 years or more, diagnosed with pregnancy-related LBPGP and who had not previously received ear acupuncture. The trial was conducted from March 2014 to December 2016. Participants were randomly assigned (1:1:1:1) to receive standard obstetric care plus two sessions (over 2 weeks) of verum ear acupuncture, or nonspecific ear acupuncture, or placebo ear acupuncture, or standard obstetric care alone. The primary outcome was change in pain intensity, assessed using a visual analog scale (0-100 mm) from baseline to the end of treatment (T2). Secondary outcomes included change or presence of pain at 3 months (T3) and at 1 year (T4) postpartum, and changes in responses to the Roland-Morris disability questionnaire (RMDQ) and Short Form-12 Health Survey (SF-12) at the end of treatment.

RESULTS

A total of 55 women were randomized to each group, and 205 completed the study. With respect to baseline values, the reduction in pain intensity among the verum ear acupuncture group vs standard obstetric care was significantly greater, both at T2 (65.8%, 95%CI 56.2-75.3 vs 25.1%, 95%CI 15.3-34.9) and at T3 (93.8%, 95%CI 88.7-99.0 vs 67.9%, 95%CI 55.3-80.5). Moreover, significant changes were found in the verum ear acupuncture group vs standard obstetric care at T2, in reduced RMDQ scores (70.9%, 95%CI 61.8-80.1 vs 21.2%, 95%CI 8.6-33.7) and in increased SF-12 scores on the physical scale (40.5%, 95%CI 31.5-49.4 vs 8.1%, 95%CI 0.8-15.5).

CONCLUSIONS

After 2 weeks of treatment, ear acupuncture applied by midwives and associated with standard obstetric care significantly reduces lumbar and pelvic pain in pregnant women, improves quality of life and reduces functional disability.

摘要

简介

由接受过培训的助产士在初级保健中进行的耳针治疗，无需专门的针灸培训，可能有助于缓解与妊娠相关的下背部和/或骨盆后带疼痛（LBPGP）。本研究的目的是评估在初级保健环境中，与标准产科护理相结合的耳针治疗对孕妇 LBPGP 的影响。

材料和方法

这是一项四组、多中心、随机对照试验，在西班牙三个地区的 18 个公共初级保健中心进行，共有 220 名 24-36 周妊娠、年龄 18 岁及以上、被诊断为妊娠相关 LBPGP 且之前未接受过耳针治疗的孕妇参与。试验于 2014 年 3 月至 2016 年 12 月进行。参与者按照 1:1:1:1 的比例随机分配接受标准产科护理加两次（2 周内）真耳针、非特异性耳针、安慰剂耳针或单独标准产科护理。主要结局是从基线到治疗结束（T2）时使用视觉模拟量表（0-100mm）评估疼痛强度的变化。次要结局包括产后 3 个月（T3）和 1 年（T4）时的疼痛变化或存在情况，以及治疗结束时 Roland-Morris 残疾问卷（RMDQ）和简短形式 12 健康调查（SF-12）的变化。

结果

每组有 55 名女性随机分配，共有 205 名女性完成了研究。就基线值而言，与标准产科护理相比，真耳针组的疼痛强度降低更为显著，T2 时为 65.8%（95%CI 56.2-75.3），T3 时为 93.8%（95%CI 88.7-99.0），而标准产科护理组分别为 25.1%（95%CI 15.3-34.9）和 67.9%（95%CI 55.3-80.5）。此外，与标准产科护理相比，真耳针组在 T2 时 RMDQ 评分降低（70.9%（95%CI 61.8-80.1））和 SF-12 评分升高（40.5%（95%CI 31.5-49.4）），而标准产科护理组仅为 21.2%（95%CI 8.6-33.7）和 8.1%（95%CI 0.8-15.5）。