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临床试验/NCT04873778
NCT04873778已完成不适用

Comparing Effects of Kinesio and Dynamic Tapings in Postpartum Women With Pelvic Girdle Pain

National Cheng Kung University2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2020年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
2
主要终点
Visual Analog Scale

研究概览

简要总结

About 45% of pregnant women and 25% of women postpartum suffer from Pelvic girdle pain. Pain is often reported to be localized between costal margin and gluteal fold with or without radiation to lower limb or symphysis pubic. Kinesio taping (KT) is the application of an elastic tape, for treating musculoskeletal conditions through enhancing muscle strength, relieving spasms, pain and edema, improving blood circulation and lymph reflux, as well as stabilizing joints. However, with limited evidence and a lack of well-designed study, the effects of KT in postpartum women with PGP remains unclear. Compared with KT, the dynamic taping(DT) is recently developed and has stronger elastic resistance and recoil. The DT may have better effects than the KT, although this notion has not been examined. In this study, we make a hypothesis that PGP women in the DT group would have better improvements on pain, disability, quality of life, and PFM functions than that in the KT group and control group.

详细描述

The main purpose for this study are to investigate the effects of KT and DT on pain, disability, physical functions, and quality of life, as well as PFM functions in postpartum women with PGP. 60 postpartum women with PGP will be randomized into one of the three groups:(1) kinesio taping group,(2) dynamic taping group (3)control group, and receive 4 weeks intervention. All participants will receive 3 assessments at the baseline, immediately after first taping session, and after 4-week interventions. The outcome measures will include Visual Analog Scale measures of pain intensity, Pelvic Girdle Questionnaire/ Oswestry Disability Index/ Patient specific functional scale measures and Global rating of change score. for disability. The quality of life will be measured by 36-item Short-Form Survey, The Physical functions include Active Straight Leg Raise Fatigue task , Time up and go test,10-meter walk test. The PFM functions will be measured by Modified Oxford grading scale and Perineometer. It is expected that PGP women in both the KT group and DT group will have more improvements than the control group. But the DT group will have even more improvements than the KT groups.

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

  • Age: > 20 year
  • Postpartum:≥ 3 months
  • Pain onset during pregnancy
  • Pain location is located between costal margin and gluteal fold with or without radiation to lower limb or symphysis pubic
  • Clinical screening test for pelvic pain :
  • Active Straight Leg Raising : positive
  • 2 (+) posterior pelvic pain provocation tests (+ symphysis ≥ 1)

排除标准

  • lumbar or pelvic surgery
  • History of fracture
  • Radiculopathy or myopathy
  • Gynaecological disorders
  • Serious cardiovascular disease
  • Diagnosed psychiatric disease
  • Ongoing pregnancy
  • Allergy to acrylic

结局指标

主要结局

Visual Analog Scale

时间窗: Change from baseline pain intensity up to 4 weeks

for pain

Oswestry Disability Index

时间窗: Change from baseline disability up to 4 weeks

for disability

10-meter walk test

时间窗: Change from baseline Physical functions up to 4 weeks

for Physical functions

Pelvic Girdle Questionnaire

时间窗: Change from disability baseline up to 4 weeks

for disability

Global rating of change score

时间窗: Change from baseline disability up to 4 weeks

for disability

Active Straight Leg Raise Fatigue task

时间窗: Change from baseline Physical functions up to 4 weeks

for Physical functions

Time up and go test

时间窗: Change from baseline Physical functions up to 4 weeks

for Physical functions

Patient specific functional scale measures

时间窗: Change from baseline disability up to 4 weeks

for disability

36-item Short-Form Survey

时间窗: Change from baseline quality of life up to 4 weeks

for quality of life

Modified Oxford grading scale

时间窗: Change from baseline PFM functions up to 4 weeks

for PFM functions

Perineometer

时间窗: Change from baseline PFM functions up to 4 weeks

for PFM functions

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

YI-JU TSAI

associate professor

National Cheng Kung University

研究点 (2)

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