Digital Training Interventions for Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Supervised digital training with focus on core stability, Supervised digital training with focus on aerobic exercise, Non-supervised daily physical activity.
- Who it may be relevant to
- Registry conditions: Low Back Pain. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Digital Training Interventions for Low Back Pain - RCT With Longitudinal Evaluation of Clinical Outcome Measures and MRI Examinations
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in Patient-reported pain [Time frame: 6 months compared to baseline]
- Change in Patient-reported pain [Time frame: 12 months compared to baseline and 6 months]
- Difference in T2 (transverse relaxation time) [Time frame: 6 months compared to baseline]
- Difference in T2 (transverse relaxation time) [Time frame: 12 months compared to baseline and 6 months]
Secondary outcome measures (12)
- Change in clinical outcomes (Standing inspection) [Time frame: 6 months compared to baseline]
- Change in clinical outcomes (Standing side-to-side symmetry) [Time frame: 6 months compared to baseline]
- Change in Clinical outcomes (Muscle hypotrophy) [Time frame: 6 months compared to baseline]
- Change in Clinical outcomes (Walking on heels) [Time frame: 6 months compared to baseline]
- Change in Clinical outcomes (Walking on toes) [Time frame: 6 months compared to baseline]
- Change in Clinical outcomes (Standing inspection) [Time frame: 12 months compared to baseline and 6 months]
- Change in Clinical outcomes (Standing side-to-side symmetry) [Time frame: 12 months compared to baseline and 6 months]
- Change in Clinical outcomes (Muscle hypotrophy) [Time frame: 12 months compared to baseline and 6 months]
- Change in Clinical outcomes (Walking on heels) [Time frame: 12 months compared to baseline and 6 months]
- Change in Clinical outcomes (Walking on toes) [Time frame: 12 months compared to baseline and 6 months]
- Change in Functional tests (Sit-to-stand test) [Time frame: 6 months compared to baseline]
- Change in Functional tests (Prone-bridge test) [Time frame: 6 months compared to baseline]
Eligibility criteria
Inclusion criteria
- Low back pain> 3 months
- Age 18-50 years
- Access to computer/tablet/mobile phone
Exclusion criteria
- Inadequate Swedish as the language is an obstacle to be able to fully understand written and oral information regarding the project and to follow training instructions
- Other ongoing treatment/exercise for their low back pain
- Patients with radiating leg pain and neurological symptoms where herniated discs are suspected
- Previous back/neck surgery
- Pregnancy
- Diagnosed systematic diseases engaging the spine as rheumatoid arthritis, ankylosing spondylitis
- Factors that prevent an MRI examination, such as claustrophobia, metal implants, etc.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Ninni Sernert — Vänersborg
Identifiers
NCT: NCT05679167 · Vastra Gotaland