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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
After randomization, Group 1 will be digitally supervised by experienced physiotherapist.
After randomization Group 2 will be digitally supervised by experienced physiotherapist.
After randomization Group 3 will receive training instruction regarding daily physical activity.
Ninni Sernert
Vänersborg, Sweden
RECRUITINGChange 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)
Time frame: 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
Time frame: 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
Time frame: 6 months compared to baseline
Difference in T2 (transverse relaxation time)
MRI can characterize tissue by two different relaxation times, T1 and T2
Time frame: 12 months compared to baseline and 6 months
Change in clinical outcomes (Standing inspection)
Normal spine curvature (yes/no)
Time frame: 6 months compared to baseline
Change in clinical outcomes (Standing side-to-side symmetry)
Standing side-to-side symmetry (yes/no)
Time frame: 6 months compared to baseline
Change in Clinical outcomes (Muscle hypotrophy)
Muscle hypotrophy (yes/no)
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Time frame: 6 months compared to baseline
Change in Clinical outcomes (Walking on heels)
Ability to walk on heels (yes/no)
Time frame: 6 months compared to baseline
Change in Clinical outcomes (Walking on toes)
Ability to walk on toes (yes/no)
Time frame: 6 months compared to baseline
Change in Clinical outcomes (Standing inspection)
Normal spine curvature (yes/no)
Time frame: 12 months compared to baseline and 6 months
Change in Clinical outcomes (Standing side-to-side symmetry)
Standing side-to-side symmetry (yes/no)
Time frame: 12 months compared to baseline and 6 months
Change in Clinical outcomes (Muscle hypotrophy)
Muscle hypotrophy (yes/no)
Time frame: 12 months compared to baseline and 6 months
Change in Clinical outcomes (Walking on heels)
Ability to walk on heels (yes/no)
Time frame: 12 months compared to baseline and 6 months
Change in Clinical outcomes (Walking on toes)
Ability to walk on toes (yes/no)
Time frame: 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)
Time frame: 6 months compared to baseline
Change in Functional tests (Prone-bridge test)
Prone-bridge test (total sec)
Time frame: 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)
Time frame: 6 months compared to baseline
Change in Functional tests (Sit-to-stand test)
Sit-to-stand test (number of rises during 30 sec)
Time frame: 12 months compared to baseline and 6 months
Change in Functional tests (Prone-bridge test)
Prone-bridge test (total sec)
Time frame: 12 months compared to baseline and 6 months
Change in Functional tests (Åstrand ergometer test)
Åstrand ergometer test (estimated VO2-max)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months compared to baseline and 6 months