Low Back Pain
Conditions
Keywords
MRI, Physiotherapy, Supervised digital training
Brief 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.
Interventions
BEHAVIORALSupervised digital training with focus on core stability
After randomization, Group 1 will be digitally supervised by experienced physiotherapist.
BEHAVIORALSupervised digital training with focus on aerobic exercise
After randomization Group 2 will be digitally supervised by experienced physiotherapist.
BEHAVIORALNon-supervised daily physical activity
After randomization Group 3 will receive training instruction regarding daily physical activity.
Sponsors
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Both patients and physiotherapists know what intervention group they were randomized to.
Intervention model description
Three ongoing different treatments at the same time
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-reported pain | 6 months compared to baseline | Visual Analog Scale (VAS), registration 0 (=no pain)-100 (=worst pain), where In the minimal clinically significant change has been estimated as 11 points on a 100-point scale patients with rheumatoid arthritis, the minimal clinically significant change has been estimated as 1.1 points on an 11-point scale (or 11 points on a 100-point scale) |
| Difference in T2 (transverse relaxation time) | 6 months compared to baseline | MRI can characterize tissue by two different relaxation times, T1 and T2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical outcomes (Muscle hypotrophy) | 6 months compared to baseline | Muscle hypotrophy (yes/no) |
| Change in Clinical outcomes (Walking on heels) | 6 months compared to baseline | Ability to walk on heels (yes/no) |
| Change in Clinical outcomes (Walking on toes) | 6 months compared to baseline | Ability to walk on toes (yes/no) |
| Change in Clinical outcomes (Standing inspection) | 12 months compared to baseline and 6 months | Normal spine curvature (yes/no) |
| Change in Clinical outcomes (Standing side-to-side symmetry) | 12 months compared to baseline and 6 months | Standing side-to-side symmetry (yes/no) |
| Change in Functional tests (Sit-to-stand test) | 6 months compared to baseline | Sit-to-stand test (number of rises during 30 sec) |
| Change in Functional tests (Prone-bridge test) | 6 months compared to baseline | Prone-bridge test (total sec) |
| Change in clinical outcomes (Standing inspection) | 6 months compared to baseline | Normal spine curvature (yes/no) |
| Change in PROM (Standardized National standardized questions on physical activity) | 6 months compared to baseline | Standardized National standardized questions on physical activity (grading activity in minutes/week). |
| Change in PROM (Oswestry Low Back Disability Index) | 6 months compared to baseline | Oswestry Low Back Disability Index (0-4 No disability, 5-14 Mild disability, 15-24, Moderate disability, 25-34 Severe disability). |
| Change in PROM (Hospital Anxiety and Depression Scale (HAD)) | 6 months compared to baseline | Hospital Anxiety and Depression Scale (HAD) 0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal). |
| Change in PROM (The 5-level EQ-5D version (EQ-5D-5L)) | 6 months compared to baseline | The 5-level EQ-5D version (EQ-5D-5L) according to EuroQol Group The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. |
| Change in PROM (Tampa Scale of Kinesiophobia (TSK)) | 6 months compared to baseline | Tampa Scale of Kinesiophobia (TSK) is 17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia. |
| Change in PROM (Generalized Self-Efficacy Scale (GSES)) | 6 months compared to baseline | Generalized Self-Efficacy Scale (GSES), a 10 item self-report measure of self-efficacy, with a higher score indicating more self-efficacy. |
| Change in Functional tests (Åstrand ergometer test) | 6 months compared to baseline | Åstrand ergometer test (estimated VO2-max, a measure of the maximum amount of oxygen your body can utilize during exercise) |
| Change in clinical outcomes (Standing side-to-side symmetry) | 6 months compared to baseline | Standing side-to-side symmetry (yes/no) |
Countries
Sweden
Contacts
Primary ContactJenny Sivertsson, Msc
Backup ContactKristina Åhlund, PhD
Outcome results
None listed