跳至主要内容
临床试验/NCT05181384
NCT05181384已完成不适用

Pelvic Floor Muscles and Stabilization Integrated Training With Transabdominal Ultrasonography-guided Biofeedback Improved Pregnancy-related Pelvic Girdle Pain and Disability: A Randomized Controlled Trial

YI-JU TSAI1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2019年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
53
试验地点
1
主要终点
pain intensity measure of pelvic girdle questionnaire(PGQ)

研究概览

简要总结

Pregnancy-related pelvic girdle pain (PPGP) is a common musculoskeletal problem for women during pregnancy and after delivery. The main purpose of this study was to investigate the effects of integrated training for pelvic floor muscles (PFMs) and stabilization with and without transabdominal ultrasonography (TAUS) imaging-guided biofeedback on pain, disability, and physical function, and muscle functions for the abdominal muscles and PFMs in postpartum women with PPGP.

详细描述

Many women have pregnancy-related pelvic girdle pain (PPGP), and about 30% with PPGP women still complain of pain after 1-year postpartum. Both physical and mental functions of PPGP women are impaired. Pelvic stabilization exercise with pelvic floor muscle training is believed to be effective for reducing pain and improved pelvic stability. However, intervention studies on PPGP women is limited and current evidence are controversial. Incorrect pelvic floor muscle activations may be partly contributed to these results. One previous study has showed about 60% of women cannot activate pelvic floor muscles correctly. Transabdominal sonography-guided biofeedback by observing bladder movements is no-invasive and benefit learning correct muscle contraction. Therefore, the main purposes for this study are to investigate the effects of pelvic stabilization training using transabdominal sonography-guided biofeedback in postpartum women with PPGP. A total of 50 postpartum PPGP women will be randomized into one of the two groups: (1) biofeedback group, (2) exercise group, (3) control group, and (4) health group. Subjects in the biofeedback group and exercise group will perform the same exercise training for 8 weeks except the subjects in the biofeedback group will receive transabdominal sonography-guided biofeedback of bladder movement for the first 4 weeks. The outcome assessment will include the muscle thickness of abdominal muscle and pelvic floor muscle control, functional performance of ASLR fatigue task, timed up and go and fast walking, pelvic girdle questionnaire (PGQ), and numeric rating scale (NRS). It is anticipated that the biofeedback group will have more improvements that the exercise group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • postpartum : ≥ 3 months
  • pregnancy-related pelvic pain
  • pain location is located between posterior iliac crest and gluteal fold
  • Clinical screening test for pelvic pain: ASLR : positive and SI joint ≥ 2 (+ symphysis ≥ 1)

排除标准

  • lumbar or pelvic surgery
  • lother causes of pelvic pain (such as fractures)
  • lRadiculopathy
  • lother health problems, such as cancer, cardiovascular disease, rheumatism , etc
  • ldaily activities limited , unable to complete the experiment
  • lcommunication disorders
  • lmental disorder
  • lpregnancy
  • lhave been trained in stable muscle strength in the past.

结局指标

主要结局

pain intensity measure of pelvic girdle questionnaire(PGQ)

时间窗: Change from baseline to 8 weeks

pelvic girdle questionnaire(PGQ) is a self-reported instrument assessing pelvic girdle pain intensity in currently. Questionnaire consisting of 20 activity items and 5 symptom items on a 4-point response scale. Possible score range from 0 (no pain) to 100 (worst possible pain).

pain intensity measure of Numeric Rating Scale (NRS)

时间窗: Change from baseline to 8 weeks

Numeric Rating Scale (NRS) is a self-reported instrument assessing average pain intensity in currently. Possible score range from 0 (no pain) to 10 (worst possible pain).

次要结局

  • functional performance of ASLR fatigue task(Change from baseline to 8 weeks)
  • functional performance of timed up and go test(Change from baseline to 8 weeks)
  • functional performance of 6m timed walk test (fast walking)(Change from baseline to 8 weeks)
  • Muscle function measures of abdominal muscle(Change from baseline to 8 weeks)
  • Muscle function measures of pelvic floor muscle control(Change from baseline to 8 weeks)

研究者

发起方
YI-JU TSAI
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

YI-JU TSAI

professor

National Cheng Kung University

研究点 (1)

Loading locations...

相似试验

Pelvic Floor Muscles and Stabilization Integrated... | 临床试验