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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supervised digital training: core stability | Active Comparator | 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 |
|
| Supervised digital training: aerobic exercise | Active Comparator | 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 |
|
| Non-supervised daily physical activity | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised digital training with focus on core stability | Behavioral | After randomization, Group 1 will be digitally supervised by experienced physiotherapist. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenny Sivertsson, Msc | Contact | 4610-435000 | jenny.sivertsson@vgregion.se | |
| Kristina Åhlund, PhD | Contact | kristina.ahlund@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Ninni IE Sernert, PhD | Göteborg University | Study Director |
| Kerstin Lagerstrand, PhD | Göteborg University | Study Chair |
| Helena Brisby, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ninni Sernert | Recruiting | Vänersborg | 462 55 | Sweden |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 16, 2022 | Jan 9, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Three ongoing different treatments at the same time
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Both patients and physiotherapists know what intervention group they were randomized to.
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| Supervised digital training with focus on aerobic exercise | Behavioral | After randomization Group 2 will be digitally supervised by experienced physiotherapist. |
|
| Non-supervised daily physical activity | Behavioral | After randomization Group 3 will receive training instruction regarding daily physical activity. |
|
| 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 |
| Göteborg University |
| Study Chair |
| Hanna Hebelka Bolminger, PhD | Göteborg University | Study Chair |
| D013568 |
| Pathological Conditions, Signs and Symptoms |