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.

Phase 3

Suspended

• Conditions: M40.30; M40.04; M51.2; M41.96; M48.06; M40.46; M54.17; M43.16; M54.8; M54.9

• Registration Number: DRKS00025531
• Lead Sponsor: niversitätsmedizin der Johannes Gutenberg-Universität Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

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).

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study is to demonstrate the positive effect of care by increasing adherence to exercise therapy (X minutes).

Secondary Outcome Measures

Name	Time	Method
Further positive care effects of increased exercise therapy are self-reported quality of life (measured with the EQ-5D-5L), pain symptomatology (Numerical Rating Scale Pain), and muscular-functional stabilization of the spine (approximations to mean norm values) regarding the variables: vertical deviation [mm], pelvic obliquity [mm], pelvic torsion [°], maximum kyphosis angle [°], maximum lordosis angle [°], maximum surface rotation [°], and maximum lateral deviation [mm]).<br>