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临床试验/NCT03997695
NCT03997695Unknown不适用

A Comparison of the Effects of Core Stabilization Exercise Plus Kinesio Taping to Exercise Alone on Pain, Fatigue, Health Status, Quality of Life, Sleep Quality and Depression in Woman With Fibromyalgia

Ankara Yildirim Beyazıt University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
34
试验地点
2
主要终点
Pain level

研究概览

简要总结

This study aimed to compare the effectiveness of a 6-week core stabilization exercise (CSE) program with and without kinesio taping on pain, fatigue, health status, quality of life, sleep quality and depression in woman with fibromyalgia.

Participants were allocated into two groups as CSE and CSE plus kinesio taping group. Pain, fatigue, health status, quality of life, sleep quality and depression were assessed at the baseline and after 6-weeks treatment.

详细描述

A 6-weeks prospective randomized controlled trial examined the effects of core stabilization exercise (CSE) plus kinesio taping (KT) compared to CSE alone on pain, fatigue, health status, quality of life, sleep quality and depression in woman with FM. The trial was approved by the Ethics committee of Ankara Yildirim Beyazit University (Approval time and number: 17.01.2018-14). The study was performed in compliance with Helsinki Declaration where applicable. The patient's recruitment started in February 2018. The patients diagnosed with Fibromyalgia according to the criteria of the 1990 American College of Rheumatology participated in the study. Prior to the treatment and after 6-weeks treatment, participants' pain level, fatigue, health status, quality of life (QoL), psychological status and sleep quality were assessed. Assessments were realized by face-to-face interview method.Patients who participated in CSE group performed CSE program alone, whereas patients in CSE+KT group performed CSE program with KT application. The treatment was carried out 2 days a week for 6 weeks.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosed with Fibromyalgia, being woman, having moderate or severe pain according to Visual Analog Scale, 18-65 years of age and being volunteer for the study

排除标准

  • having neurologic, infectious, and endocrine diseases, malignancy, being pregnant, severe psychological disorders, any changing of medications during treatment, being allergic to taping, any condition interfering with exercise (advanced cardiac, respiratory or musculoskeletal problems), and intervention including exercise program or physical therapy in the last 6 months.

研究组 & 干预措施

Core stabilization exercise group

Active Comparator

Core stabilization exercise (CSE):

The CSE program was carried out 2 days a week for 6 weeks (12 sessions) by supervisor physiotherapist. The CSE program aimed to perform neutral spine and activation of core muscles. Prior to the CSE program, participants were informed about core musculature and their function.The 6-weeks CSE program was performed in stages with gradual progression according to the stages of motor learning and sensory motor integration as static, dynamic, and functional.

干预措施: Core stabilization exercise group (Other)

Core stabilization exercise plus kinesio taping group

Experimental

Core stabilization exercise (CSE):

The CSE program was carried out 2 days a week for 6 weeks (12 sessions) by supervisor physiotherapist. The CSE program aimed to perform neutral spine and activation of core muscles. Prior to the CSE program, participants were informed about core musculature and their function.The 6-weeks CSE program was performed in stages with gradual progression according to the stages of motor learning and sensory motor integration as static, dynamic, and functional.

Kinesio Taping:

The Kinesio Taping was carried out 2 days a week for 6 weeks (12 sessions) by experienced and certificated physiotherapist. Kinesio taping was applied to spinal region.

干预措施: Core stabilization exercise plus kinesio taping group (Other)

结局指标

主要结局

Pain level

时间窗: Two years

Pain level was assessed with Visual Analog Scale.

次要结局

  • Depression(Two years)
  • Fatigue(Two years)
  • Life Quality(Two years)
  • Health Status(Two years)
  • Sleep Quality(Two years)

研究者

发起方
Ankara Yildirim Beyazıt University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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