DRKS00029408进行中（未招募）未知
Kaia back pain for the treatment of non-specific low back pain in adult patients - a randomised controlled trial - SWA
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 87
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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 95 Years（—）
- 性别
- All
入选标准
- •1. Age: 18 years and above
- •2. Low back pain (M54.4, M54.5, M54.85-89, M54.95-99) lasting 4 weeks or longer or recurring back pain
- •3. ODI score above 20 % = moderate disability at the screening and baseline visit
- •4. Able to speak, read and understand German
- •5. Willing and capable of providing informed consent to use Kaia Back Pain and participate in all assessments associated with the clinical study
- •6. In possession of a smartphone and willing and able to use it for study purposes
排除标准
- •1. Diagnosis of specific underlying cause of back pain (red-flags”) at baseline according to German treatment guidelines NVL (spinal fracture, spinal tumour, spinal infection, disc herniation with unambiguous symptoms, spinal stenosis, inflammatory back pain)
- •2. Prior or planned surgery for back pain
- •3. Chiropractic care, acupuncture, injections, or other non-pharmacological treatment for back pain covered by statutory health care in the one month before screening
- •4. Self-reported prior use of Kaia Back Pain or other digital applications to treat non-specific back pain within 12 months prior to screening or plans to participate in any other investigational trials or protocols for back pain within 90 days
- •5. Inability to perform the exercises of Kaia Back Pain independently (e.g., inability to carry out exercises on the floor and to get back up)
- •6. Severe or unstable medical condition (e.g., unstable cardiac disease, active infection, stroke with residual neuromuscular effects, paralysis, gait imbalance, history of recent recurrent falls) as assessed by the investigator
- •7. Self-reported concurrent conditions that could interfere with evaluation of back pain results, including fibromyalgia, rheumatoid arthritis, or inflammatory arthropathies affecting the knee or hip joints, or other conditions in the opinion of the investigator that may interfere with safety, conduct of the study, or evaluation
- •8. Known pregnancy at screening or plans to become pregnant during study
研究者
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