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临床试验/NCT04139603
NCT04139603已完成不适用

Gebeliğe Bağlı Lumbopelvik Ağrıda İki Farklı Kinezyo Bant Uygulamasının Ağrı ve Fonksiyonel Mobilite Üzerine Etkisi

Muğla Sıtkı Koçman University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年1月27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
55
试验地点
1
主要终点
Change in time of completing stair climbing test (seconds)

研究概览

简要总结

This study evaluates and compares the effects of two different kinesio taping applications on pain and functional mobility in pregnancy related lumbopelvic pain.

详细描述

Literature studies on the effectiveness of kinesio taping (KT) in pregnancy related lumbopelvic pain (LPP) are limited in number and have methodological shortcomings such as lack of randomization, a control group or assessor and/or patient blindness. Although generally presenting a significant effectiveness of KT on intensity of pain and disability, these parameters are evaluated by subjective methods, and the findings do not rely on quantitative data, in general.

In addition, the intervention parameters used in these studies, such as the KT techniques used, amount of KT tension and duration of the intervention are different from each other, and there is lack of studies comparing the effectiveness of different KT techniques.

In this study, effectiveness of two different KT applications will be compared with placebo KT:

  1. Lumbopelvic KT (LPKT): Two I-shaped kinesio tapes in 40 cm length will be applied bilaterally, beginning from 5 cm below the spina iliaca posterior superiors (SIPSs) to the level of the 12th costae, in maximum trunk flexion position, on the paravertebral muscles, by inhibition technique of muscle correction techniques. The tapes will be placed with no tension at 5 cm of both ends, and with 15-25% tension in between. In addition, an extra I-shaped tape will be placed perpendicullar to these tapes with the ligament correction technique, while the pregnant women are in the vertical upright position, at the level of the sacroiliac joints, starting with a tensile strength of 75-100% from the middle, and then with no tension at two ends.
  2. Abdominal supported LPKT (ALPKT): An abdominal support tape will be added to the LPKT. In order to reduce the tension of the uterus ligaments, and to help perception of the normal elasticity of the target tissues, ligament technique will be used. The middle part of an I-shaped tape will be placed to the midpoint of the lower abdomen, and then will be progressed laterally and above with 50% tension.

For placebo application, a Micropore™ surgical plaster of the same color with KT will be applied with no tension, as described in the LPKT technique.

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
Double (Participant, 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 lumbar or pelvic girdle pain for at least 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 lumbopelvic pain (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 lumbopelvic pain
  • Any ddiagnosed pregnancy complications (preeclampsy, pregnancy related hypertension, diabetes, fetal anomaly, etc.)
  • Multiple gestation
  • History of spinal injury, ankylosing spondilitis, rheumatoid arthritis, intervertebral disc pathology
  • Positive straight leg raising test result or peripheral sensory or motor impairments which may indicate lumbar interbertebral disc pathology
  • History of prepregnancy low back pain
  • Using any analgesic or myorelaxant medication
  • Contraindications to KT (impaired skin integrity or lesion in the lumbopelvic and abdominal regions, history of allergic reaction, etc.)
  • previous KT experience

结局指标

主要结局

Change in time of completing stair climbing test (seconds)

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

The participants will be asked to ascend and descend 10 stairs. Time of completing the test will be recorded in seconds. Lower times indicate better functional mobility level in stair activities

Change in pain intensity during timed up and go (TUG) test

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

0 (no pain)-10 cm (unbearable pain) visual analogue scales will be used.

Change in pain intensity during stair climbing test

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

0 (no pain)-10 cm (unbearable pain) visual analogue scales will be used.

Change in pain intensity during resting

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

0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.

Change in time of completing five times sit to stand test (seconds)

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

The participants will sit on a straight back chair (43 cm height) with arms folded across their chest. They will be instructed to stand up and sit down as quickly as possible 5 times, keeping their arms folded across their chest. Time for completing the test will be recorded (sec). Lower times indicate better functional mobility level for sit to stand activity.

Change in pain intensity during five times sit to stand test

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

0 (no pain)-10 cm (unbearable pain) visual analogue scales will be used.

Change in time of completing timed up and go test (seconds)

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

All participants will perform the test from a chair (height: 46 cm) with back-support. They will be asked to stand up, walk three meters, turn around, walk back to the chair, and sit down as fast as they can. Time to complete the test will be recorded (sec). Lower times indicate better functional mobility level for walking.

次要结局

  • Change in activity limitation(baseline, three days after the first taping, and one week after the first taping)

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)

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