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临床试验/NCT05860218
NCT05860218招募中不适用

A Suggested Functional Exercises Program For Patients With Chronic Mechanical Low Back Pain

Doha Ali Amin Ahmed1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
52
试验地点
1
主要终点
pain in lower back

研究概览

简要总结

The aim of this study will be to investigate the effect of functional exercise on pain, functional disability and core strength in patients with chronic mechanical low back pain .

详细描述

To our knowledge, there has been not enough studies that investigated the effect of core strengthening by functional exercise on pain, functional disability and core muscle strength in patients with chronic mechanical low back pain. Therefore, this study may open up ways to other researchers to investigate and build up on this effect if present and address such an important issue.

the finding of this proposed work may help patients with chronic mechanical low back pain by addressing their pain, functional limitation, and/or participation restrictions. Consequently, this can speed up their recovery, return to work, decrease cost of treatment, improve psychological status, decrease level of irritability, and improve overall quality of life.

Patients with chronic mechanical low back pain will be recruited after approval of ethical committee of the faculty of physical therapy, Cairo University. All participants will sign a written informed consent form.

The subjects will be randomly assigned into one of two groups:

  • Group I (control) will receive advices only.
  • Group II (experimental) will receive a suggested functional exercise program plus advises.

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
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic mechanical low back pain and their age will be ranged from 20 -45 years.
  • History of chronic low back pain (≥3 months).
  • Patients with Body Mass Index (BMI) between 18-28

排除标准

  • Age younger than 20 or older than 45 years of age.
  • History of any surgical procedure in the back or the lower extremities
  • Back pain secondary to known specific pathology (e.g. infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis) or cauda equine syndrome).
  • Patient with lumbar instability including spondylolisthesis.
  • Red flags (e.g. fever, unexplained weight loss, progressive weakness, radiation to lower limb, bowel and bladder dysfunction).
  • Pregnancy.

结局指标

主要结局

pain in lower back

时间窗: change from max pain point in 1 month

will be measured by The Numeric Pain Rating Scale (NPRS). it consists of The 11-point numeric scale ranges from '0' representing one pain extreme (e.g., "no pain") to '10' representing the other pain extreme (e.g., "pain as bad as you can imagine" or "worst pain imaginable .patients are asked to indicate the point along the line that best reflect their pain intensity .

functional disability

时间窗: change in 1 month

will be measured by Arabic version of Oswestry Disability Index (ODI) is a self-reported questionnaire consisting of 10 questions related to back function . Each question is answered on a 6-item Likert scale and is scored from 0 (minimum degree of difficulty in that activity) to 5 (maximum degree of difficulty). These questions assess the activities of daily living in patients with LBP. The questions in the index include pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. The validity of Arabic version of ODI is good intra-observer reliability was excellent . The correlations of the ODI with the VAS pain scale, the Roland-Morris Low Back Pain Disability and the Quebec Back Pain Disability.

core muscles stability

时间窗: change in 1 month

The researcher will conduct a series of core stability tests before and after the core training program. Core stability tests has been reported to be highly reliable (ICC ≥ 0.98) and showed moderate to high correlation with one another (correation coefficient ranged from 0.4 to 0.8) , The following core tests will be used: trunk flexion test (McGill's test) , Trunk extension (Sorenson Test) , Side plank test and prone plank test .

lower limb function

时间窗: change in 1 month

will measured by Functional assessment using one legged hops test The most commonly used functional tests are a series of one-legged hops described by Noyes et al. (1991). The sensitivity of the single (49%), triple (50%), crossover (58%), and timed (52%) hop tests were reported by Noyes et al. (1991). The specificity was 97% and 94% for the timed and single hops, respectively

次要结局

未报告次要终点

研究者

发起方
Doha Ali Amin Ahmed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Doha Ali Amin Ahmed

principal investigator

Cairo University

研究点 (1)

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