Multidisciplinary Digital Therapeutics for Chronic Low Back Pain Versus In-person Education Combined With Physiotherapy, a Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- EverEx Inc.
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Functional disability assessed by Oswestry Disability Index (ODI)
研究概览
简要总结
This randomized controlled pilot study will be evaluating an app, MORT-LBP app (ETH-02K), owned by EverEx, Inc., to examine safety and efficacy in individuals with chronic lower back pain.
详细描述
This randomized controlled pilot study will enroll 46 participants, where half will be randomly assigned to the app, MORT-LBP (n = 23), and half will be assigned to treatment as usual (TAU) (n = 23), to examine safety and efficacy in individuals with chronic lower back pain. All subjects will be followed up in the study for a total of 12 weeks, 8-week courses of treatment with additional 4-week observation. The app provides multidisciplinary rehabilitation treatment, a combination of graded exercise therapy and cognitive behavioural therapy for patients with chronic lower back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 19 and <65 years of age
- •Patients who have a history of lower back pain persisting for longer than 12 weeks
- •Patients who have average back pain score of 3 or more on the numeric rating scale (NRS)
- •Patients who can use application-based therapy with his/her smartphone
- •Patients who signed a written informed consent form
- •Patients who are able to comply with the plan, as determined by the study investigator.
排除标准
- •Patients who have previous history of spinal surgery
- •Patients who have previous history of spinal trauma within 3 months
- •Patients with lower extremity radicular pain with sensory and motor dysfunction
- •Patients with lower extremity muscle strength of 3 or less on a manual muscle test
- •Patients with spondylolysis or spondylolisthesis
- •Patients with other structural abnormalities of the spine, including scoliosis (Cobb's angle > 10 degrees) or kyphosis (lordotic angle < 0 degrees)
- •Patients with red flag signs (paralyzing symptoms such as fecal impairment, sudden unexplained weight loss)
- •Patients with tumors, infections, metabolic bone disease, cognitive impairment, fibromyalgia, and systemic inflammatory diseases
- •Patients with other systemic disease conditions that limit exercise therapy, as determined by the study investigator
- •Patients who are pregnant or breastfeeding
- •Patients with known substance/alcohol use disorders
- •Patients who are not able to participate in an exercise or strengthening program
- •Patients taking opioid analgesic medications with a potency greater than or equal to tramadol for other conditions or low back pain
研究组 & 干预措施
MORT-LBP
Participants randomly assigned to this arm will use the app, MORT-LBP.
干预措施: MORT-LBP (Device)
treatment as usual (TAU)
Participants randomly assigned to this arm will receive their TAU only (no use of the app, MORT-LBP).
干预措施: treatment as usual (TAU) (Other)
结局指标
主要结局
Functional disability assessed by Oswestry Disability Index (ODI)
时间窗: 8 weeks
The primary outcome being measure is differences in functional disability between groups after the intervention. Oswestry Disability Index (ODI) is a patient reported assessment of chronic lower back pain-specific functional limitations. It has 10 questions, total score ranging from 0 to 50, and ODI is calculated with (total score)/(answered question number \* 5)\*100%. Higher index means worse outcome.
Usual pain severity in the past week assessed by the Numeric Rating Scale (NRS)
时间窗: 8 weeks
The primary outcome being measure is differences in usual pain severity in the past week between groups after the intervention. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).
Worst pain severity in the past week assessed by the Numeric Rating Scale (NRS)
时间窗: 8 weeks
The primary outcome being measure is differences in worst pain severity in the past week between groups after the intervention. NRS score was measured from 0 (no pain) to 10 (worst pain imaginable).
次要结局
- Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D)(4, 8, 12 weeks)
- Ususal pain severity in the past week assessed by Numeric Rating Scale (NRS)(4, 12 weeks)
- Assessment of spinal alignment status measured by X-ray(8 weeks)
- Changes of Single-limb stance test, Prone bridge test and Borg CR10 Scale (2010)(4, 8, 12 weeks)
- Functional disability assessed by Oswestry Disability Index (ODI)(4, 12 weeks)
- Assessment of fear avoidance behaviours measured by Fear-Avoidance Beliefs Questionnaire (FABQ)(8, 12 weeks)
- Assessment of Equilibrium Ability by Single-limb stance test(4, 8, 12 weeks)
- Worst pain severity in the past week assessed by Numeric Rating Scale (NRS)(4, 12 weeks)
- Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)(8, 12 weeks)
- Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS)(8, 12 weeks)
- Changes of usual and worst pain severity in the past week assessed by Numeric Rating Scale (NRS)(4, 8, 12 weeks)
- Use of rescue medication(4, 8, 12 weeks)
- Changes of Oswestry Disability Index (ODI) and EuroQol five-dimensional (EQ-5D)(4, 8, 12 weeks)
- Assessment of app usability by surveys(4, 8 weeks)
- Assessment of Muscular Endurance by Prone bridge test and Borg CR10 Scale (2010)(4, 8, 12 weeks)
- Assessment of retention in treatment(4, 8 weeks)