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临床试验/NCT04377516
NCT04377516撤回不适用

Effects of Specific Pelvic Stabilization Exercise With Transabdominal Ultrasonography-guided Biofeedback in Postpartum Women Suffering From Pregnancy-related Pelvic Girdle Pain

YI-JU TSAI1 个研究点 分布在 1 个国家开始时间: 2019年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Muscle function measures of inter recti distance

研究概览

简要总结

Postpartum women with PPGP receiving specific pelvic stabilization exercise training with transabdominal sonography-guided Biofeedback would have better improvements on muscle functions, physical functions, pain, and disability compared to the regular pelvic stabilization 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
是

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
  • •other causes of pelvic pain (such as fractures)
  • •Radiculopathy
  • •other health problems, such as cancer, cardiovascular disease, rheumatism , etc
  • •daily activities limited , unable to complete the experiment
  • •communication disorders
  • •mental disorder
  • •pregnancy
  • •have been trained in stable muscle strength in the past.

研究组 & 干预措施

Health group

Placebo Comparator

pelvic girdle education

干预措施: education of pelvic girdle (Other)

Transabdominal Sonography-guided Biofeedback group

Experimental

pelvic floor muscle training with transabdominal sonography-guided Biofeedback

干预措施: pelvic floor muscle combined global muscle exercise training (Other)

Transabdominal Sonography-guided Biofeedback group

Experimental

pelvic floor muscle training with transabdominal sonography-guided Biofeedback

干预措施: education of pelvic girdle (Other)

Exercise group

Active Comparator

pelvic floor muscle training

干预措施: pelvic floor muscle training (Other)

Exercise group

Active Comparator

pelvic floor muscle training

干预措施: pelvic floor muscle combined global muscle exercise training (Other)

Exercise group

Active Comparator

pelvic floor muscle training

干预措施: education of pelvic girdle (Other)

Control group

Placebo Comparator

pelvic girdle education

干预措施: education of pelvic girdle (Other)

Transabdominal Sonography-guided Biofeedback group

Experimental

pelvic floor muscle training with transabdominal sonography-guided Biofeedback

干预措施: pelvic floor muscle training (Other)

结局指标

主要结局

Muscle function measures of inter recti distance

时间窗: 8 weeks

Untrasonography image for muscle thickness of inter recti distance during rest, maximum contraction, and ASLR test.

functional performance of 6m timed walk test(fast walking)

时间窗: 8 weeks

Subjects commenced the test in standing with their toes up against the tape marker. Test instructions translated into English were as follows: 'After "ready, set, go", walk as fast as you can up to the last white line without stopping or speaking along the way'. Performances were timed (to the nearest 100th of a second) between the 2m and 8m markers and later converted into speed in metres per second.

pain intensity measure of Numeric Rating Scale (NRS)

时间窗: 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).

functional performance of timed up and go test

时间窗: 8 weeks

Test instructions were given in Norwegian. Translated into English, the instructions were as follows: 'After "ready, set, go" stand up, walk as fast as you can until you cross the white line, turn around, and walk back to the chair and sit down again'. The white line was positioned 3m from the patient's starting position. 'After "ready, set, go" stand up, walk as fast as you can until you cross the white line, turn around, and walk back to the chair and sit down again'. The white line was positioned 3m from the patient's starting position.

pain intensity measure of pelvic girdle questionnaire (PGQ)

时间窗: 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 Oswestry Low Back Pain Disability Questionnaire (ODI)

时间窗: 8 weeks

Oswestry Low Back Pain Disability Questionnaire(ODI) is a self-reported instrument assessing patient's permanent functional disability in currently. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. The higher the score, the greater the degree of disability.

functional performance of ASLR fatigue task

时间窗: 8 weeks

Participants lifted the heel of the test leg to 20 cm for as long as possible. Participants were required to maintain pressure in the cuff beneath their back as close to 40 mm Hg as possible. Visual feedback of cuff pressure was provided throughout the task, but no instruction was given on how to affect cuff pressure. Task failure was defi ned as an inability to maintain heel height 10 cm or more off the plinth and/or a change in cuff pressure of 20 mm Hg or more.

Muscle function measures of abdominal muscle

时间窗: 8 weeks

Untrasonography image for muscle thickness of abdominal muscle during rest and ASLR test.

Muscle function measures of pelvic floor muscle control

时间窗: 8 weeks

Untrasonography image for muscle thickness of pelvic floor muscle control during rest, maximum contraction, and ASLR test.

次要结局

  • General health(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)

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