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临床试验/NCT05301491
NCT05301491已完成不适用

Investigation of the Effects of Dance Therapy on Balance, Falling, Body Awareness and Functionality in Women With Chronic Low Back Pain

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年2月1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
40
试验地点
1
主要终点
Change from baseline in body awareness ratio score

研究概览

简要总结

The aim of this study is to investigate the effect of dance therapy on balance, falling, body awareness and functionality parameters in patients with chronic low back pain. As a result of our study, it is thought that dance therapy will positively affect balance, falling, body awareness and functionality in patients with chronic low back pain compared to conventional therapy.

H 1: Dance therapy improves balance in women with chronic low back pain.

H 2: Dance therapy reduces the risk of falling in women with chronic low back pain.

H 3: Dance therapy increases body awareness in women with chronic low back pain.

H 4: Dance therapy increases functionality in women with chronic low back pain.

H 5: Dance therapy provides more improvement in the parameters investigated compared to conventional therapy in women with chronic low back pain.

详细描述

Individuals diagnosed with chronic low back pain and meeting the inclusion criteria are going to be included in the study. These individuals are going to be divided into groups as the odd numbers to study group and even numbers to the control group. Hotpack, ultrasound and Transcutaneous Electrical Nerve Stimulation (TENS) are going to be applied to the patients in the both groups for 3 days a week for 2 months. Besides that, control group is going to perform 40-minute classical exercise program 3 days a week for 2 months. Study group is going to perform dance therapy protocol as indicated below;

  • 10 minutes warm-up (stepping),
  • 25 minutes of dance (such as; steps, figures using hip and knee flexions, hip circulation, and hip rotations)
  • 5 minutes stretching (relaxation) exercises.

Demographic information form is going be filled out patients including information about; age, height (cm), weight (kg), occupation, educational status, bilateral leg length (cm), previous and present diseases, waist/hip ratio, previous surgeries, trunk range of motions, low back pain duration, smoking, falling story. Additionally, following questionnaires are going to be applied to both groups;

  • Short Form Mc Gill Pain Questionnaire,
  • Oswestry Disability Index,
  • Body Awareness Ratio Questionnaire,
  • Nottingham Health Profile Questionnaire,
  • Tampa Kinesiophobia Scale,
  • The World Health Organization Quality of Life (WHOQoL) Scale,
  • Y balance test
  • Time Up and Go (TUG) test

SPSS version 23 (SPSS Inc, Armonk, NY) program will be used in the analysis of the data. Mann Whitney U test, Wilcoxon test and student t test will be analyse methods.

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
None

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

  • Those who agree to participate in the study voluntarily
  • Having low back pain lasting longer than 3 months,
  • Having values between 4 and 7 on the Visual Analog Scale.
  • Female individuals between the ages of 18-65

排除标准

  • ; Those with a Body Mass Index (BMI) greater than 35 kg/m², pregnant women, those with following problems; neural findings, malignancy, inflammation, arthritis, metabolic bone disease, column vertebralis or lower extremity surgery, cardiovascular system diseases, severe osteoporosis, communication and hearing disorders, and those who illiterate, receive other treatment for low back pain.

结局指标

主要结局

Change from baseline in body awareness ratio score

时间窗: 8 weeks

Body awareness ratio score is going to be assess by Body Awareness Ratio Questionnaire to determine change from baseline.

Change from baseline in functionality score

时间窗: 8 weeks

Functionality score is going to be assess by Oswestry Disability Index to determine change from baseline.

Change from baseline in Time Up and Go test seconds

时间窗: 8 weeks

Falling risk is going to be assess by Time Up and Go test seconds to determine change from baseline.

Change from baseline in Y balance test score

时间窗: 8 weeks

Balance score is going to be assess by Y balance test to determine change from baseline.

次要结局

  • Change from baseline in kinesiophobia score(8 weeks)
  • Change from baseline in perceived health status score(8 weeks)
  • Change from baseline in waist/hip ratio(8 weeks)
  • Change From Baseline in Pain Scores(8 weeks)
  • Change from baseline in quality of life score(8 weeks)
  • Change from baseline in range of motion degree(8 weeks)

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Dinler

Research assistant

Hasan Kalyoncu University

研究点 (1)

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