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电针对产后腹直肌分离的疗效:一项随机对照临床试验。

Efficacy of electro-acupuncture in postpartum with diastasis recti abdominis: A randomized controlled clinical trial.

机构信息

The Second Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, China.

Zhejiang Chinese Medical University, Hangzhou, China.

出版信息

Front Public Health. 2022 Nov 15;10:1003361. doi: 10.3389/fpubh.2022.1003361. eCollection 2022.

Abstract

BACKGROUND

Electro-acupuncture (EA) has promising effects on diastasis rectus abdominis (DRA), defined as a separation of the two muscle bellies of rectus abdominis. To study, there is scant knowledge or scarce high-quality evidence.

OBJECTIVE

We aimed to evaluate the long-term efficacy and safety of EA in treating DRA during postpartum. It was assumed that the improvement of DRA was more obvious in the EA group than in the control group.

DESIGN

Randomized, controlled, blinded trial (Clinical Trial Registration: ChiCTR2100041891).

SETTING

Hangzhou Hospital of Traditional Chinese Medicine in China.

PARTICIPANTS

Females aged 20-45 years without a past medical history of pathological rectus abdominal dissection were recruited from DRA inclusion criteria from 42 days to 1 year postpartum.

INTERVENTION

110 participants were randomly assigned in a 1:1 ratio to a control group with no EA intervention ( = 55), and EA group ( = 55). The EA group received ten sessions of EA combined with physical exercise or only physical exercise for 2 weeks with a 26-week follow-up.

MEASUREMENTS

Outcomes were assessed at baseline, week 2, and week 26. The primary outcome was the change of the inter recti distance (IRD) and electromyographic evaluation of the pelvic floor. Secondary outcomes included elasticity of linea alba (LA), paraumbilical subcutaneous adipose tissue (SAT) measurement, body mass index (BMI), percentage body fat (F%), dyspepsia symptoms, menstrual symptoms, quality of life (QoL), pain performance of patients with lower back pain, postnatal depression symptoms (PDS), postpartum self-image, and DRA-related symptom assessment including urine leakage, frequency, and urgency, constipation, sexual dysfunction, and chronic pelvic pain.

RESULTS

A total of 110 maternal (55 in each group) were recruited. The mean difference in IRD from baseline to week 2 and week 26 in all states of the two groups were reduced compared with those before treatment, with statistical significance ( < 0.05). The mean of IRD at the horizontal line of the umbilicus in the end-expiratory state was smaller in the EA group than in the control group, but the difference was not statistically significant ( > 0.05) at week 2. The mean of IRD at the horizontal line of the umbilicus in head-up and flexed knee state was smaller in the EA group than in the control group, and the difference was statistically significant ( < 0.05) at week 26. Five (9.1%) and thirteen (23.64%) adverse events were reported in EA and control groups, respectively. No serious adverse events were reported.

LIMITATION

The frequency intensity of EA parameters was selected between 4 and 6 because of individual tolerance differences.

CONCLUSION

EA is an effective approach to improve IRD, electromyographic evaluation of the pelvic floor, BMI, the elasticity of LA, paraumbilical SAT, and symptoms of DRA, with durable effects at 26 weeks.

PRIMARY FUNDING SOURCE

The Construction Fund of Medical Key Disciplines of Hangzhou (Project Number: OO20200097), Hangzhou Medical and Health Science and Technology Project No. A20200483, and Zhejiang Traditional Chinese Medicine Science and Technology Plan Project (Project Number: 2021ZQ065).

CLINICAL TRIAL REGISTRATION

http://www.chictr.org.cn/index.aspx, identifier: ChiCTR2100041891.

摘要

背景

电针(EA)对腹直肌分离(DRA)有显著疗效,DRA 定义为腹直肌的两个肌腹分离。目前研究较少,高质量证据匮乏。

目的

评估产后 EA 治疗 DRA 的长期疗效和安全性。假设 EA 组对 DRA 的改善效果优于对照组。

设计

随机、对照、盲法试验(临床试验注册:ChiCTR2100041891)。

地点

中国杭州市中医院。

参与者

招募了年龄在 20-45 岁之间、无病理性腹直肌分离病史的女性,纳入标准为产后 42 天至 1 年的 DRA。

干预

110 名参与者按 1:1 的比例随机分配到对照组(无 EA 干预,n=55)和 EA 组(n=55)。EA 组接受 10 次 EA 联合物理运动或仅物理运动,为期 2 周,随访 26 周。

测量

在基线、第 2 周和第 26 周评估结局。主要结局是 IRD 的变化和盆底肌的肌电图评估。次要结局包括白线弹性(LA)、脐周皮下脂肪组织(SAT)测量、体重指数(BMI)、体脂百分比(F%)、消化不良症状、月经症状、生活质量(QoL)、下腰痛患者的疼痛表现、产后抑郁症状(PDS)、产后自我形象和 DRA 相关症状评估,包括尿失禁、频率、尿急、便秘、性功能障碍和慢性盆腔疼痛。

结果

共招募 110 名产妇(每组 55 名)。两组在所有状态下,IRD 从基线到第 2 周和第 26 周的平均差异均较治疗前降低,具有统计学意义(<0.05)。在呼气末水平,EA 组的 IRD 平均值小于对照组,但差异无统计学意义(>0.05)。在仰卧位和屈膝位,EA 组的 IRD 平均值小于对照组,差异具有统计学意义(<0.05)。EA 组有 5(9.1%)例和对照组有 13(23.64%)例发生不良事件。未报告严重不良事件。

局限性

由于个体耐受差异,EA 参数的频率强度选择在 4-6 之间。

结论

EA 是一种有效改善 IRD、盆底肌肌电图、BMI、LA 弹性、脐周 SAT 和 DRA 症状的方法,在 26 周时具有持久疗效。

主要资金来源

杭州市医学重点学科建设基金(项目编号:OO20200097)、杭州市医疗卫生科技项目(项目编号:A20200483)和浙江省中医药科技计划项目(项目编号:2021ZQ065)。

临床试验注册

http://www.chictr.org.cn/index.aspx,标识符:ChiCTR2100041891。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc4d/9724647/46951a6c019c/fpubh-10-1003361-g0001.jpg

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