跳至主要内容
临床试验/NCT04401683
NCT04401683撤回不适用

Home-based Exercise Rehabilitation With a Novel Digital Biofeedback System for Non-specific Chronic Low Back Pain: a Randomized Controlled Trial

Sword Health, SA2 个研究点 分布在 1 个国家开始时间: 2021年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Change in Oswestry Disability Index (ODI) score

研究概览

简要总结

The present study is a a single-center, prospective, non-blind, parallel-group, randomized controlled trial, designed to evaluate the clinical impact of a home-based program using a new digital solution on the treatment of non-specific chronic low back pain (CLBP) in adults versus standard of care.

The hypothesis is that all the clinical outcomes measured will significantly improve after the program, and patients using this novel system will attain better outcomes than the ones in the standard of care group.

This evidence-based digital program developed by SWORD Health is built on three main pillars - therapeutic exercise, education and cognitive-behavioural therapy, and is specifically tailored to address CLBP. The program will be delivered directly at patient's home, using a biofeedback system and continuous personalised remote clinical monitoring.

详细描述

Low back pain (LBP) has for long been the world's leading cause of years leaved with disability, 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, and behavioural therapy as the mainstays 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. Importantly, however, the main driver of the direct cost component in the care of LBP is physical therapy, meaning new ways of delivering therapy are warranted.

Besides exercise therapy, opioid prescription is also a common practice, despite known opioid-related morbidity and mortality rates. Because the prevalence of CLBP is continuously rising, and opioid misuse is an issue of great concern globally, identifying effective non-opioid alternatives for CLBP is of paramount importance.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18 and 70 years
  • Intermittent or persistent low back pain for at least 3 months and on at least half the days in the previous 6 months without peripheral symptoms
  • Ability to understand motor complex commands

排除标准

  • Pregnancy or breast-feeding
  • Inability to stand upright
  • Clear indication for surgery or other medical treatment (e.g. cancer, infection, cauda equina syndrome, significant lumbar disc herniation or rupture, nerve compression)
  • Acute low back pain in the past 7 days or unilateral or bilateral radicular pain
  • Neurologic condition (e.g. stroke, multiple sclerosis, Parkinson's disease)
  • Concomitant treatment for LBP
  • Cardiac, respiratory or other condition incompatible with at least 30 minutes of light to moderate physical activity
  • Severe reduction of visual and/or auditory acuity, aphasia, dementia or psychiatric comorbidity significantly interfering with communication or compliance to a home-based exercise program
  • Osteoarticular condition (e.g. fractures or severe osteoarthrosis) that prevents the patient from complying with a home-based exercise program
  • Other medical complications that prevent the patient from complying with a home-based exercise program

结局指标

主要结局

Change in Oswestry Disability Index (ODI) score

时间窗: Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program

The ODI is a condition-specific self-reported measure, that aims to assess the level of disability in different physical activities in patients with low back pain. Scoring: 10 items, each with 6 possible answers (scored from 0 to 5 points) and a total score ranging from 0-100, being 100 the worst function/disability possible. The total score of ODI is calculated through te total sum of the section scores, divided by the total possible score and the result is then multiplied by 100, to achieve a percentage score.

次要结局

  • Change in Fear-Avoidance Beliefs Questionnaire (FABQ)(Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program)
  • Change in Numeric Rating Scale (NRS) score(Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program)
  • Change in Pain Catastrophizing Scale (PCS)(Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program)

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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