Digital Training Interventions for Low Back Pain

Study Overview
=================
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.

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

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: Supervised digital training with focus on core stability
* Behavioral: Supervised digital training with focus on aerobic exercise
* Behavioral: Non-supervised daily physical activity


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three ongoing different treatments at the same time
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supervised digital training: core stability<br>The patients will be identified at the primary health center and after fulfilling the inclusion criteria and all baseline examination are completed the patients will be randomized. In group 1 the patients will attend supervised digital training with focus on core stability | Behavioral: Supervised digital training with focus on aerobic exercise<br>* After randomization Group 2 will be digitally supervised by experienced physiotherapist.<br>Behavioral: Non-supervised daily physical activity<br>* After randomization Group 3 will receive training instruction regarding daily physical activity.<br>|
| Active Comparator: Supervised digital training: aerobic exercise<br>The patients will be identified at the primary health center and after fulfilling the inclusion criteria and all baseline examination are completed the patients will be randomized. In group 2 the patients will attend supervised digital training with focus on aerobic exercise | Behavioral: Supervised digital training with focus on core stability<br>* After randomization, Group 1 will be digitally supervised by experienced physiotherapist.<br>Behavioral: Non-supervised daily physical activity<br>* After randomization Group 3 will receive training instruction regarding daily physical activity.<br>|
| Active Comparator: Non-supervised daily physical activity<br>The patients will be identified at the primary health center and after fulfilling the inclusion criteria and all baseline examination are completed the patients will be randomized. In group 3 will start a daily physical activity program, with regular support from a physiotherapist. | Behavioral: Supervised digital training with focus on core stability<br>* After randomization, Group 1 will be digitally supervised by experienced physiotherapist.<br>Behavioral: Supervised digital training with focus on aerobic exercise<br>* After randomization Group 2 will be digitally supervised by experienced physiotherapist.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient-reported pain | 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) | 6 months compared to baseline | 
| Change in Patient-reported pain | 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 | 12 months compared to baseline and 6 months | 
| Difference in T2 (transverse relaxation time) | MRI can characterize tissue by two different relaxation times, T1 and T2 | 6 months compared to baseline | 
| Difference in T2 (transverse relaxation time) | MRI can characterize tissue by two different relaxation times, T1 and T2 | 12 months compared to baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical outcomes (Standing inspection) | Normal spine curvature (yes/no) | 6 months compared to baseline | 
| Change in clinical outcomes (Standing side-to-side symmetry) | Standing side-to-side symmetry (yes/no) | 6 months compared to baseline | 
| Change in Clinical outcomes (Muscle hypotrophy) | Muscle hypotrophy (yes/no) | 6 months compared to baseline | 
| Change in Clinical outcomes (Walking on heels) | Ability to walk on heels (yes/no) | 6 months compared to baseline | 
| Change in Clinical outcomes (Walking on toes) | Ability to walk on toes (yes/no) | 6 months compared to baseline | 
| Change in Clinical outcomes (Standing inspection) | Normal spine curvature (yes/no) | 12 months compared to baseline and 6 months | 
| Change in Clinical outcomes (Standing side-to-side symmetry) | Standing side-to-side symmetry (yes/no) | 12 months compared to baseline and 6 months | 
| Change in Clinical outcomes (Muscle hypotrophy) | Muscle hypotrophy (yes/no) | 12 months compared to baseline and 6 months | 
| Change in Clinical outcomes (Walking on heels) | Ability to walk on heels (yes/no) | 12 months compared to baseline and 6 months | 
| Change in Clinical outcomes (Walking on toes) | Ability to walk on toes (yes/no) | 12 months compared to baseline and 6 months | 
| Change in Functional tests (Sit-to-stand test) | Sit-to-stand test (number of rises during 30 sec) | 6 months compared to baseline | 
| Change in Functional tests (Prone-bridge test) | Prone-bridge test (total sec) | 6 months compared to baseline | 
| Change in Functional tests (Åstrand ergometer test) | Åstrand ergometer test (estimated VO2-max, a measure of the maximum amount of oxygen your body can utilize during exercise) | 6 months compared to baseline | 
| Change in Functional tests (Sit-to-stand test) | Sit-to-stand test (number of rises during 30 sec) | 12 months compared to baseline and 6 months | 
| Change in Functional tests (Prone-bridge test) | Prone-bridge test (total sec) | 12 months compared to baseline and 6 months | 
| Change in Functional tests (Åstrand ergometer test) | Åstrand ergometer test (estimated VO2-max) | 12 months compared to baseline and 6 months | 
| Change in PROM (Standardized National standardized questions on physical activity) | Standardized National standardized questions on physical activity (grading activity in minutes/week). | 6 months compared to baseline | 
| Change in PROM (Oswestry Low Back Disability Index) | Oswestry Low Back Disability Index (0-4 No disability, 5-14 Mild disability, 15-24, Moderate disability, 25-34 Severe disability). | 6 months compared to baseline | 
| Change in PROM (Hospital Anxiety and Depression Scale (HAD)) | Hospital Anxiety and Depression Scale (HAD) 0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal). | 6 months compared to baseline | 
| Change in PROM (The 5-level EQ-5D version (EQ-5D-5L)) | 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. | 6 months compared to baseline | 
| Change in PROM (Tampa Scale of Kinesiophobia (TSK)) | 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. | 6 months compared to baseline | 
| Change in PROM (Generalized Self-Efficacy Scale (GSES)) | Generalized Self-Efficacy Scale (GSES), a 10 item self-report measure of self-efficacy, with a higher score indicating more self-efficacy. | 6 months compared to baseline | 
| Change in PROM (Standardized National standardized questions on physical activity) | Standardized National standardized questions on physical activity (grading activity in minutes/week). | 12 months compared to baseline and 6 months | 
| Change in PROM (Oswestry Low Back Disability Index) | Oswestry Low Back Disability Index (0-4 No disability, 5-14 Mild disability, 15-24, Moderate disability, 25-34 Severe disability). | 12 months compared to baseline and 6 months | 
| Change in PROM (Hospital Anxiety and Depression Scale (HAD)) | Hospital Anxiety and Depression Scale (HAD) 0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal). | 12 months compared to baseline and 6 months | 
| Change in PROM (The 5-level EQ-5D version (EQ-5D-5L)) | 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. | 12 months compared to baseline and 6 months | 
| Change in PROM (Tampa Scale of Kinesiophobia (TSK)) | 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. | 12 months compared to baseline and 6 months | 
| Change in PROM (Generalized Self-Efficacy Scale (GSES)) | Generalized Self-Efficacy Scale (GSES), a 10 item self-report measure of self-efficacy, with a higher score indicating more self-efficacy. | 12 months compared to baseline and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Physiotherapy, Supervised digital training