M40.3 M40.0 M51.2 M41.9 M48.0 M40.4 M54.1 M43.1 M54.8 M54.9
Conditions
Interventions
Group 1: Randomly assigned back pain patients will receive treatment equivalent to "usual care" by a physical therapist
Group 2: Randomly assigned back pain patients will receive a 12-week customized
Sponsors
Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Back pain/dorsopathy, e.g., due to any of the following findings: a. Flat back (ICD-10 code M40.30 = "Flat back - Multiple localizations 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. ISG block (ICD-10 code M54.17 = "Radiculopathy: lumbosacral region") h. Slipped vertebra (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
Exclusion criteria: Patients who meet at least one of the following criteria will not be included in this clinical trial: - Uncontrolled hypertension - Heart failure - Acute myocardial infarction - Cardiac arrhythmia - Acute disc herniation - Fresh vertebral body fractures - Pregnancy - Pre-existing severe osteoporosis - Acute or chronic infection - Acute dizziness/discomfort - Surgery in the last 3 months or to the spine/ extremities in the last 12 months - Suspected injury to the spine - Spinal tumor - Spinal infections - acute severe pain in the musculoskeletal system - Decreased control of the legs - gait insecurities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the verification of positive therapy success through higher adherence to exercise therapy (in minutes). | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition, we will investigate whether increased adherence within exercise therapy provides pain reduction (VAS), improved quality of life (5Q-5D-5L), and increasing convergence to mean normal values of certain musculoskeletal characteristics (variable perpendicular deviation [mm], pelvic obliquity [mm], pelvic torsion [°], maximum kyphosis angle [°], maximum lordosis angle [°], maximum surface rotation [°], and maximum lateral deviation [mm]). | — |
Countries
Germany
Contacts
Public ContactHannah Lena Siebers
Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie der Uniklinik RWTH Aachen
Outcome results
None listed