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临床试验/NCT04643756
NCT04643756
已完成
不适用

Investigation of the Effects of Two Different Treatment Programs on Pain Severity, Low Back Awareness, Functional and Psychosocial Factors in Patients With Chronic Low Back Pain

Pamukkale University1 个研究点 分布在 1 个国家目标入组 52 人2020年1月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Chronic Low-back Pain
发起方
Pamukkale University
入组人数
52
试验地点
1
主要终点
Functional assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
状态
已完成
最后更新
4年前

概览

简要总结

This study was planned to examine the effects of two different treatment programs on pain intensity, back awareness, functional and psychosocial factors in patients with chronic low back pain.

详细描述

Recent study will be carried out on volunteer patients who applied to the Physical Therapy Clinic of "Mugla Sitki Kocman University" Training and Research Hospital, who were diagnosed with chronic non-specific low back pain and who comply with the study criteria. The sample size has been calculated that 80% power can be obtained at 95% confidence level. It was found that at least 21 cases, a total of 44 cases, were required for each group. Volunteers will be divided into 2 groups by randomization. Conventional physiotherapy applications will be applied to the control group. In addition to conventional physiotherapy methods, kinesio-taping (KT) will be applied to the study group. Patients in both groups will be treated 5 days a week for a total of 10 sessions for 2 weeks. KT will be renewed in each session on weekdays.

注册库
clinicaltrials.gov
开始日期
2020年1月1日
结束日期
2021年8月1日
最后更新
4年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Özgür Nadiye Karaman

Physiotherapist, MSc

Pamukkale University

入排标准

入选标准

  • Male and female patients aged 18 to 60 years with chronic low back pain
  • Those who have complained of low back pain for at least 3 months
  • Individuals whose pain intensity is above 3.5 cm according to VAS
  • Pain and numbness that does not spread to the legs

排除标准

  • Situations that prevent the evaluation or communication with the individual
  • Illiterate individuals
  • Individuals who have undergone surgical operations on the spine and / or extremities
  • Conditions where specific pathological conditions are proven such as malignant condition, fracture, systemic rheumatoid disease
  • Orthopedic and neurological problems that prevent evaluation and / or treatment
  • Complaints of pain and numbness spreading to the lower extremities
  • Individuals with a diagnosed psychiatric illness
  • Individuals who have received physiotherapy in the last 6 months
  • Individuals who use another treatment method during the study
  • Individuals with musculoskeletal pain in any other part of the body during work

结局指标

主要结局

Functional assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks

时间窗: Baseline, 3 weeks, 6 weeks

Repeated Sit-to-Stand Test

Timed Up and Go Test Change from baseline at 3 weeks and Change from baseline at 6 weeks

时间窗: Baseline, 3 weeks, 6 weeks

Timed Up and Go Test

Pain assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks

时间窗: Baseline, 3 weeks, 6 weeks

Visual Analogue Scale (VAS): The patient is asked to mark the pain felt on a 10 cm.

Awareness Assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks

时间窗: Baseline, 3 weeks, 6 weeks

Fremantle Back Awareness Questionnaire (FreBAQ): FreBAQwill be used for awareness.

Assessing Kinesophobia Change from baseline at 3 weeks and Change from baseline at 6 weeks

时间窗: Baseline, 3 weeks, 6 weeks

Fear-Avoidance Beliefs Questionnaire (FABQ):It measures the patient's fear of movement caused by low back pain.

Assessment of depression and anxiety level Change from baseline at 3 weeks and Change from baseline at 6 weekschanging from baseline at 6 weeks

时间窗: Baseline, 3 weeks, 6 weeks

Hospital and Anxiety Depression Scale (HADS):Anxiety and depression levels will be evaluated subjectively with the Hospital Anxiety and Depression Scale.

Modified Schober Test Change from baseline at 3 weeks and Change from baseline at 6 weeks

时间窗: Baseline, 3 weeks, 6 weeks

Modified Schober Test

Disability level Change from baseline at 3 weeks and Change from baseline at 6 weeks.

时间窗: Baseline, 3 weeks, 6 weeks

Roland Morris Disability Questionnaire.

研究点 (1)

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