跳至主要内容
临床试验/NCT04266184
NCT04266184Unknown不适用

Gebeliğe Bağlı Pelvik Kuşak Ağrısında Pelvik Kemer ve Kinezyo Bant Uygulamalarının Ağrı ve Fonksiyonel Mobilite Üzerine Etkileri

Muğla Sıtkı Koçman University1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2020年3月13日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
47
试验地点
1
主要终点
change in pain intensity during five-stairs climbing test

研究概览

简要总结

This study investigates the effects of pelvic belt (PB) and kinesio taping (KT) applications on pain and functional mobility in pregnancy-related pelvic girdle pain (PGP), in comparison with the control group that received only pain neuroscience education and ergonomic training.

详细描述

Although there is strong evidence in the literature that pelvic support belts reduce pain in pregnancy-related pelvic girdle pain, no study investigating its effect on functional mobility with performance-based measurement methods or investigating its effectiveness on kinesiophobia has been found. Studies investigating the efficacy of KT in pregnant women with PGP are few and many are methodologically weak studies, most of which do not contain randomization and control groups. Also, no study has been found in the literature, which compares the effectiveness of PB and KT in pregnant women with PGP. Therefore, the primary aim of this study is to examine the effects of PB and KT on pain and functional mobility in pregnant women with PGP in comparison with the control group, which is only given pain neuroscience education and ergonomic training. The secondary aims are to investigate the effects of these applications on kinesiophobia, activity limitation and sleep quality; and to compare the groups in regard to patient compliance and treatment satisfaction levels of the 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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • being able to read and write in Turkish
  • being in 2nd or 3rd trimester of pregnancy
  • having PGP for more than one week
  • signing the informed consent form for the study

排除标准

  • visual, auditory or cognitive problems which may prevent participation to the study
  • health problems other than pregnancy-related PGP (orthopedic, neurologic, cardiorespiratory, etc.) or trauma history, which may affect standing from sitting, walking or stair climbing activities
  • any gynecological or urological problems which may mimic pregnancy related PGP
  • any diagnosed pregnancy complications other than PGP (preeclampsy, hypertension, diabetes,placental/fetal anomaly, preterm labor, etc.)
  • high risk pregnancy (multiple gestation, etc.)
  • history of spinal injury, ankylosing spondilitis, rheumatoid arthritis, intervertebral disc pathology)
  • A positive straight leg raise test result, as well as sensory or motor deficits indicating intervertebral disc pathology
  • history of prepregnancy low back or pelvic girdle pain
  • using any analgesic or myorelaxant medication
  • contraindications to KT or PB (impaired skin integrity or lesion in the lumbopelvic and abdominal regions, history of allergic reaction, etc.)
  • previous KT (abdominal or lumbosacral) or PB experience

结局指标

主要结局

change in pain intensity during five-stairs climbing test

时间窗: baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention

The women will be asked to mark their pain intensity during five-stairs climbing test. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.

change in pain intensity during timed up and go test

时间窗: baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention

The women will be asked to mark their pain intensity during timed up and go test. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.

change in general pain intensity during activity

时间窗: baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention

The women will be asked to mark their pain intensity during activities in general. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.

change in pain intensity during five times sit to stand test

时间窗: baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention

The women will be asked to mark their pain intensity during five times sit to stand test. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.

change in impairment during active straight leg raise test

时间窗: baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention

The women will be asked to score their impairment during active straight leg raise test. 0 (not difficult at all)-5 (unable to do) scoring system will be used. Scores for right and left legs will be summed and recorded.

次要结局

  • change in activity limitation(baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention)
  • change in kinesiophobia(baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention)
  • treatment satisfaction(baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention)
  • change in sleep quality(baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention)
  • patient compliance(baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention)

研究者

发起方
Muğla Sıtkı Koçman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

İlkim Çıtak Karakaya, PT. PhD. Prof.

Prof.

Muğla Sıtkı Koçman University

研究点 (1)

Loading locations...

相似试验