NCT05679167

Digital Training Interventions for Low Back Pain

Digital Training Interventions for Low Back Pain - RCT With Longitudinal Evaluation of Clinical Outcome Measures and MRI Examinations

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The patients will be clinically examined, as well as evaluated with Patient Reported Outcome Measures (PROMs) and Magnet Resonance Imaging (MRI) at baseline and at follow-ups.

Detailed description

The overall aim is to evaluate two different types of digital training interventions supervised by physiotherapists compared to daily physical activity in terms of clinical, imaging-based and patient-reported outcome in patients with low back pain. Furthermore, to evaluate whether new diagnostic MRI methods can identify longitudinal spine tissue changes and to analyse if there is an exercise-related difference. Patients seeking primary health care for lower back pain will be randomized to three groups. The patients will be clinically examined, assessed with Magnet Resonance Imaging (MRI) and Patient Reported Outcome Measures (PROMs) will be evaluated at baseline and at follow-ups. A detailed description of the study protocol, see attached document.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
BEHAVIORAL	Supervised digital training with focus on core stability	After randomization, Group 1 will be digitally supervised by experienced physiotherapist.
BEHAVIORAL	Supervised digital training with focus on aerobic exercise	After randomization Group 2 will be digitally supervised by experienced physiotherapist.
BEHAVIORAL	Non-supervised daily physical activity	After randomization Group 3 will receive training instruction regarding daily physical activity.

Timeline

• Start date: 2023-01-20
• Primary completion: 2025-06-30
• Completion: 2026-12-31
• First posted: 2023-01-10
• Last updated: 2023-04-26

Locations

1 site across 1 country: Sweden