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临床试验/NCT04808141
NCT04808141已完成不适用

Digital Care Program for Chronic Low Back Pain Versus Conventional Physical Therapy: a Prospective, Randomized Controlled Study

Sword Health, SA2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年5月25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
140
试验地点
2
主要终点
Oswestry Disability Index Score (ODI)

研究概览

简要总结

New ways of delivering care are much needed to address chronic low back pain. Crucially, these need to: a) address the three pillars of care to achieve good and sustained clinical outcomes; b) overcome barriers to access; c) ensure patients are engaged throughout the programs; d) be scalable and cost-efficient. SWORD Health has developed a digital care program to address these needs. This study aims to assess the clinical outcomes of this rehabilitation program versus conventional physical therapy.

详细描述

Low back pain (LBP) has for long been the world's leading cause of years leaved with disability,1 and, considering that the overall life expectancy is rising, this pandemic only tends to get worse. Nearly everyone is affected by LBP at some moment in life (70-80% of lifetime prevalence). As a consequence, LBP is also presented as a leading cause of work absenteeism worldwide. Thus, although the estimate costs of LBP may be difficult to compare between different countries, its overwhelming socio-economic impact in modern society is evident.

In the absence of an effective treatment, LBP can become chronic, causing a huge impact in patients' daily life, and ultimately promoting a high consumption of healthcare resources. In the US alone, health expenditures for adults with spinal problems were estimated at $6000 per person, representing a total cost of $102 billion each year.

The dim picture described above highlights the urgent need for effective interventions that minimize disability, improve quality of life and decrease productivity losses.

Current guidelines on CLBP management recommend patient education, exercise, physical therapy (PT), and behavioural therapy as the mainstay treatments for this condition.

Despite some discrepancy in the type of exercise program (e.g. aquatic exercises, stretching, back schools, McKenzie exercise approach, yoga, tai-chi) and mode of delivery (e.g., individually designed programs, supervised home exercise, and group exercise), exercise therapy is recommended nearly transversally, with most studies concluding that exercise intervention programs should include a combination of muscular strength, flexibility and aerobic fitness exercises. Moreover, home exercises with a regular therapist follow-up has proven highly effective.

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 (Outcomes Assessor)

盲法说明

Blinding of investigators and patients regarding allocation arm will not be possible, given the nature of the intervention. Analysis of study results will be performed by a statistician blinded to allocation groups.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged between 18 and 80 years of age at enrolment
  • Reporting intermittent or persistent low back pain for at least 12 weeks, and/or present at least 50% of the time in the past 6 months
  • Ability to understand complex motor tasks

排除标准

  • Known pregnancy
  • Submitted to spinal surgery less than 3 months ago
  • Symptoms and/or signs indicative of possible infectious disorder
  • Known disorder with indication for spine surgery (i.e., tumor, cauda equina syndrome)
  • Cancer diagnosis or undergoing treatment for cancer
  • Cardiac, respiratory or other known disorder incompatible with at least 20 minutes of light to moderate physical activity
  • Concomitant neurological disorder (e.g. Stroke, multiple sclerosis, Parkinson's disease)
  • Dementia or psychiatric disorders precluding patient from complying with a home-based exercise program
  • Illiteracy and/or serious visual or auditory impairment interfering with communication or compliance

结局指标

主要结局

Oswestry Disability Index Score (ODI)

时间窗: Baseline and 8 weeks after initiation of rehabilitation program

The minimum value of the score is 0% and the maximum is 100%, with lower scores translating into lower disability. In this study, we will be assessing the change between baseline and 8 weeks in Oswestry Disability Index score.

次要结局

  • Pain Level(Baseline and 8 weeks after initiation of rehabilitation program)
  • Work Productivity and Activity Impairment (WPAI) Overall(Baseline and 8 weeks after initiation of rehabilitation program)
  • Interest in Undergoing Surgery(Baseline and 8 weeks after initiation of rehabilitation program)
  • Medication Consumption(Baseline and 8 weeks after initiation of rehabilitation program)
  • Fear Avoidance Beliefs - Physical Activity (FABQ-PA)(Baseline and 8 weeks after initiation of rehabilitation program)
  • Anxiety(Baseline and 8 weeks after initiation of rehabilitation program)
  • Patient Satisfaction With Intervention(8 weeks after initiation of rehabilitation program.)
  • Physical Activity Levels(Baseline and 8 weeks after initiation of rehabilitation program)
  • Depression(Baseline and 8 weeks after initiation of rehabilitation program)
  • Retention Rate(Between baseline and 8 weeks.)
  • Treatment Intensity(Between baseline and 8 weeks.)
  • Work Productivity and Activity Impairment (WPAI) Work(Baseline and 8 weeks after initiation of rehabilitation program)
  • Work Productivity and Activity Impairment (WPAI) Time(Baseline and 8 weeks after initiation of rehabilitation program)
  • Work Productivity and Activity Impairment (WPAI) Activity(Baseline and 8 weeks after initiation of rehabilitation program)
  • Dropout Rate(Program-end)
  • Frequency of Sessions Per Week(8-weeks)
  • Total Sessions(8 weeks)

研究者

发起方
Sword Health, SA
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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