Pilot study to evaluate an additional 12-week training with the iDIERS app

Phase 3

• Conditions: M40.3; M40.0; M51.2; M41.9; M48.0; M40.4; M54.1; M43.1; M54.8; M54.9

• Registration Number: DRKS00027300
• Lead Sponsor: Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie

Brief Summary

Background: Back pain is one of the major health issues in Germany and often has various causes. Therefore, a multidimensional therapeutic approach has increasingly been chosen in recent years to functionally rehabilitate patients. Digital health apps offer a promising, supportive, and complementary treatment approach for the future. Objective: The aim of this study is to prepare the evaluation of a positive care effect through the iDiers app. Method: Two groups were examined. The intervention group received physiotherapy and training with the iDiers app, while the control group only received physiotherapy. The therapy progress of both groups was observed over twelve weeks. At the first examination appointment and after 12 weeks, both groups underwent spinal measurement using raster stereography. Both groups were asked to complete questionnaires on pain and quality of life and record training times in the training diary in the app. The training times should include training with the app, the physiotherapy sessions, and additional training in the iDiers app. Results: A total of 4 patients were examined (female, mean age of 35 years, height of 171 cm, and weight of 76 kg), one additional patient did not finish participation. One patient (30 years, 160 cm, 80 kg) received only physiotherapy, and the other three patients received physiotherapy and exercises with the iDiers app. It was found that two of the three patients who received physiotherapy and exercises with the iDiers app improved more spinal parameters than the patient who only received physiotherapy. There were no unexpected side effects. Limitations: Unfortunately, recruitment was challenging, and there were also gaps in data collection. The rasterstereographic data was not saved for one patient and there are always gaps in the data recorded by the app. Conclusions: Helpful data were collected to demonstrate a positive care effect of the app. Additionally, concrete suggestions for improvement in study design can be made based on the initial findings and especially the limitations. Despite the small number of patients, the study showed an improvement in spinal parameters in patients who received physiotherapy and trained with the iDiers app.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-31
• Study Completion: 2022-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 4

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the verification of positive therapy success through higher adherence to exercise therapy (in minutes).

Secondary Outcome Measures

Name	Time	Method
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]).<br>