DRKS00025531暂停3 期
Evaluation of the impact of an additional 12-week training with the iDIERS app on overall therapy adherence as well as quality of life, pain, and musculoskeletal system in patients with low back pain in direct comparison to standard physical therapy care. - iDIERS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. back pain/dorsopathy, e.g., due to any of the following findings:
- •a.Flatback-Syndrome (ICD-10 code M40.30 = Flatback-Syndrome - Multiple locations of the spine).
- •b.Hyperkyphosis of the thoracic spine (ICD-10 code M40.04 = Kyphosis as a postural disorder: Thoracic region)
- •c.Spinal disc protrusion (ICD-10 code M51.2 = Other more specifically described disc displacement, including lumbago due to disc displacement)
- •d.Right/left convex lumbar scoliosis (ICD-10 code M41.96 = Scoliosis, unspecified: lumbar region)
- •e.Lumbar spinal stenosis (ICD-10 code M48.06 = Spinal (canal) stenosis: lumbar region)
- •f.Hyperlordosis lumbar spine (ICD-10 code M40.46 = Other lordosis: lumbar region)
- •g.blocked SIJ (ICD-10 code M54.17 = Radiculopathy: lumbosacral region)
- •h.Spondylolisthesis (ICD-10 code M43.16 = Spondylolisthesis: lumbar region)
- •i.Other back pain (ICD-10 code M54.8)
- •j. Back pain, unspecified (ICD-10 code M54.9)
- •2. age 18-70 years
- •3. presence of a current therapeutic prescription for exercise therapy, with no more than the first session.
- •4. The study participant is able to understand the nature, meaning, and significance of the clinical trial.
- •5. an informed consent form signed and dated by the study participant is available before any study specific intervention is performed.
- •6. the study participant agrees to install the iDIERS app on his/her personal smartphone/tablet and to use it for documentation and possibly also for training (in case he/she is assigned to the Train with the app group).
排除标准
- •Patients who meet at least one of the following criteria will not be included in this clinical trial:
- •1. uncontrolled hypertension
- •2. heart failure
- •3. acute myocardial infarction
- •4. cardiac arrhythmias
- •5. acute disc herniation
- •6. recent vertebral fractures
- •7. pregnancy
- •8. pre-existing severe osteoporosis
- •9. acute or chronic infection
- •10. acute dizziness/discomfort
- •11. surgery in the last 3 months or to the spine/ extremities in the last 12 months
- •12. suspected injury to the spine
- •13. spinal tumor
- •14. spinal infections
- •15. acute severe musculoskeletal pain
- •16. decreased control of the legs
- •17. gait insecurity
研究者
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