Kaia back pain for the treatment of non-specific low back pain in adult patients - a randomised controlled trial
- Conditions
- M54.85 Other back pain: thoracolumbar region M54.86 OtherBack pain : Lumbar region M54.87 Other back painLumbosacral region M54.88 Other back pain : Sacralacrococcygeal region M54.89 Other back pain : UnspecifiedSacral and sacrococcygeal region M54.99Back pain, unspecified : Thoracolumbar region M54.96Back pain, unspecified : Lumbar region M54.97 Back painunspecified : lumbosacral region M54.98 Back painM54.5M54.4Low back painLumbago with sciatica
- Registration Number
- DRKS00029408
- Lead Sponsor
- Kaia Health Software GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 87
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the mean change in the ODI score from baseline to study end (day 90) across groups.
- Secondary Outcome Measures
Name Time Method 1. Percentage of patients with a 30% or greater reduction in ODI from baseline to study end<br>2. Health-related Quality of Life assessed by Short Form Health Survey 12 (SF12) <br>3. Pain intensity assessed on an 11-point NRS from baseline to study end (pain intensity evaluated as average pain intensity in the previous week)<br>4. Depression, anxiety, and stress assessed by Depression-Anxiety-Stress-Scale (DASS) <br>5. Percentage of patients with partial response (average pain in the previous week of = 2 assessed by 11-point NRS)<br>6. Percentage of patients with complete response (average pain in the previous week of 0 assessed by 11-point NRS)<br>at study end, over the duration and at baseline for the intervention group compared to the control group. <br>7. Physical function assessed by Oswestry Disability Index (ODI) version 2.1b at 30 and 60 days<br>8. Pain intensity assessed on an 11-point NRS at 30 and 60 days (pain intensity evaluated as average pain intensity in the previous week)