跳至主要内容
临床试验/NCT03994458
NCT03994458已完成不适用

The Efficacy and Compliance of Using A Smartphone Application in Treating Non-Specific Low Back Pain Among Office Employees: A Randomized Controlled Trial

Jordan University of Science and Technology2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Change in Oswestry Disability Questionnaire (ODQ) scores

研究概览

简要总结

Evaluating the efficacy of a newly developed self-monitored mobile application in reducing office workers low back pain.

详细描述

II. Introduction and Hypothesis of the Study:

Around 12% to 33% of the adult workforce are affected by low back pain (LBP) each year. Furthermore 70% to 95% of the adults are predicted to have back pain at least once in their lifetime (Van Tulder et al., 2006, Karthikeyan et al., 2013). There are numerus applications for self-management of LBP. These applications provided patients with cost-effective alternative management for their LBP. However, most of these available applications are of a low quality, because they were developed without an evidence-based vision (Machado et al., 2016).

Hypothesis:

  1. All participants who will use the full access of the LBP application for six weeks will demonstrate significant decrease in low back pain intensity as measured by Visual Analogue Scale (VAS).
  2. All participants who will use the full access of the LBP application for six weeks will demonstrate significant decrease in disability as measured by Oswestry Disability Index (ODI).
  3. All participants who will use the full access of the LBP application for six weeks will demonstrate significant perceptual satisfaction and gained benefit as measured by self-rated survey questions.

III. Aims of the study: This study aims to evaluate the efficacy and compliance in using a standardized evidence-based LBP application among office employees who suffer from non-specific LBP, in randomized controlled trial.

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)

盲法说明

Blinded evaluators and participants are not aware which version of the program they got.

入排标准

年龄范围
30 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Being office worker for at least 5 years with at least 5 hours of working daily behind the desk.
  • Middle age adults, age between 30 and 55 years old.
  • Complains of LBP at least for 3 months measured by self-report
  • Scored at least 3 point on a 0-10 Visual Analog Scale.
  • Owning an android smartphone.

排除标准

  • Diagnosed with disc herniation with radiculopathy pain.
  • Structural deformities as in Scoliosis, or Kyphosis, or Lordosis.
  • Spinal tumor.
  • Ankylosing spondylitis, spondylolisthesis.
  • Had a spine surgery or significant trauma in the past 6 months.
  • Low mental ability of not being able to use smartphone.

结局指标

主要结局

Change in Oswestry Disability Questionnaire (ODQ) scores

时间窗: Change from basleine to 6 weeks will be assessed.

A measure used to evaluate disability related to low back pain. Score range is 0-100, where higher scores indicate more disability.

Change in Visual Analog Scale (VAS) scores

时间窗: Change from basleine to 6 weeks will be assessed.

A measure used to evaluate pain related to low back pain. Score range is 0-10, where higher scores indicate more pain.

次要结局

  • Change in Pittsburgh Sleep Quality Index (PSQI) scores(Change from basleine to 6 weeks will be assessed.)
  • Change in International Physical Activity Questionnaire -short form (IPAQ-SF) scores(Change from basleine to 6 weeks will be assessed.)
  • Change in 12-item Short Form Health Survey (SF-12) scores(Change from basleine to 6 weeks will be assessed.)
  • Change in Depression, Anxiety, and Stress Scale (DASS21) scores(Change from basleine to 6 weeks will be assessed.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khader Almhdawi

Associate professor

Jordan University of Science and Technology

研究点 (2)

Loading locations...

相似试验