M54.85 Other back pain: thoracolumbar region M54.86 Other Back pain : Lumbar region M54.87 Other back pain Lumbosacral region M54.88 Other back pain : Sacral acrococcygeal region M54.89 Other back pain : Unspecified Sacral and sacrococcygeal region M54.99 Back pain, unspecified : Thoracolumbar region M54.96 Back pain, unspecified : Lumbar region M54.97 Back pain unspecified : lumbosacral region M54.98 Back pain M54.5 M54.4
Conditions
Interventions
Group 1: Control group gets usual care
Group 2: Intervention group gets usual care and uses Kaia Back Pain
Sponsors
Kaia Health Software GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 95 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the mean change in the ODI score from baseline to study end (day 90) across groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients with a 30% or greater reduction in ODI from baseline to study end 2. Health-related Quality of Life assessed by Short Form Health Survey 12 (SF12) 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) 4. Depression, anxiety, and stress assessed by Depression-Anxiety-Stress-Scale (DASS) 5. Percentage of patients with partial response (average pain in the previous week of = 2 assessed by 11-point NRS) 6. Percentage of patients with complete response (average pain in the previous week of 0 assessed by 11-point NRS) at study end, over the duration and at baseline for the intervention group compared to the control group. 7. Physical function assessed by Oswestry Disability Index (ODI) version 2.1b at 30 and 60 days 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) | — |
Countries
Germany
Outcome results
None listed