Low Back PainDigiLumNCT05679167
Digital Training Interventions for Low Back Pain
A study testing Supervised digital training with focus on core stability, Supervised digital training with focus on aerobic exercise and Non-supervised daily physical activity in people with Low Back Pain, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Supervised digital training with focus on core stability, Supervised digital training with focus on aerobic exercise and Non-supervised daily physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 20 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Low back pain> 3 months
- Age 18-50 years
- Access to computer/tablet/mobile phone
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kristina Åhlund, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Ninni Sernert
Vänersborg, 462 55
Ninni Sernert, PhD, +46702274267, ninnni.sernert@vgregion.se
Kristina Åhlund, PhD, kristina.ahlund@hv.se
About this study
Official title: Digital Training Interventions for Low Back Pain - RCT With Longitudinal Evaluation of Clinical Outcome Measures and MRI Examinations
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Supervised digital training with focus on core stability, Supervised digital training with focus on aerobic exercise, Non-supervised daily physical activity
- Keywords
- MRI, Physiotherapy, Supervised digital training
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised digital training with focus on core stabilityBehavioural
After randomization, Group 1 will be digitally supervised by experienced physiotherapist.
Supervised digital training with focus on aerobic exerciseBehavioural
After randomization Group 2 will be digitally supervised by experienced physiotherapist.
Non-supervised daily physical activityBehavioural
After randomization Group 3 will receive training instruction regarding daily physical activity.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Supervised digital training with focus on aerobic exercise; Behavioral: Non-supervised daily physical activity |
| 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 Receives: Behavioral: Supervised digital training with focus on core stability; Behavioral: Non-supervised daily physical activity |
| 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. Receives: Behavioral: Supervised digital training with focus on core stability; Behavioral: Supervised digital training with focus on aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 6 months compared to baseline
Difference in T2 (transverse relaxation time)
MRI can characterize tissue by two different relaxation times, T1 and T2
Measured: 12 months compared to baseline and 6 months
Secondary outcomes (28)
Change in clinical outcomes (Standing inspection)
Normal spine curvature (yes/no)
Measured: 6 months compared to baseline
Change in clinical outcomes (Standing side-to-side symmetry)
Standing side-to-side symmetry (yes/no)
Measured: 6 months compared to baseline
Change in Clinical outcomes (Muscle hypotrophy)
Muscle hypotrophy (yes/no)
Measured: 6 months compared to baseline
Change in Clinical outcomes (Walking on heels)
Ability to walk on heels (yes/no)
Measured: 6 months compared to baseline
Change in Clinical outcomes (Walking on toes)
Ability to walk on toes (yes/no)
Measured: 6 months compared to baseline
Change in Clinical outcomes (Standing inspection)
Normal spine curvature (yes/no)
Measured: 12 months compared to baseline and 6 months
Change in Clinical outcomes (Standing side-to-side symmetry)
Standing side-to-side symmetry (yes/no)
Measured: 12 months compared to baseline and 6 months
Change in Clinical outcomes (Muscle hypotrophy)
Muscle hypotrophy (yes/no)
Measured: 12 months compared to baseline and 6 months
Change in Clinical outcomes (Walking on heels)
Ability to walk on heels (yes/no)
Measured: 12 months compared to baseline and 6 months
Change in Clinical outcomes (Walking on toes)
Ability to walk on toes (yes/no)
Measured: 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)
Measured: 6 months compared to baseline
Change in Functional tests (Prone-bridge test)
Prone-bridge test (total sec)
Measured: 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)
Measured: 6 months compared to baseline
Change in Functional tests (Sit-to-stand test)
Sit-to-stand test (number of rises during 30 sec)
Measured: 12 months compared to baseline and 6 months
Change in Functional tests (Prone-bridge test)
Prone-bridge test (total sec)
Measured: 12 months compared to baseline and 6 months
Change in Functional tests (Åstrand ergometer test)
Åstrand ergometer test (estimated VO2-max)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months compared to baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start20 Jan 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three ongoing different treatments at the same time
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ninni Sernert, Vastra Gotaland Region
- Investigators
- Ninni IE Sernert, PhD, Study director, Göteborg UniversityKerstin Lagerstrand, PhD, Study chair, Göteborg UniversityHelena Brisby, PhD, Study chair, Göteborg UniversityHanna Hebelka Bolminger, PhD, Study chair, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679167
- Sponsor's protocol ID
- Vastra Gotaland
- Acronym
- DigiLum
- Status last verified
- Apr 2023
- First submitted
- 10 Nov 2022
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Training Interventions for Low Back Pain - RCT With Longitudinal Evaluation of Clinical Outcome Measures and MRI Examinations
- ClinicalTrials.gov ID
- NCT05679167
- Acronym / sponsor ID
- DigiLum / Vastra Gotaland
- Conditions
- Low Back Pain
- Keywords
- MRI, Physiotherapy, Supervised digital training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three ongoing different treatments at the same time
| Arm | Type | Receives |
|---|---|---|
| Supervised digital training: core stability | Active comparator | Behavioral: Supervised digital training with focus on aerobic exercise, Behavioral: Non-supervised daily physical activityThe 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 | Behavioral: Supervised digital training with focus on core stability, Behavioral: Non-supervised daily physical activityThe 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 | Behavioral: Supervised digital training with focus on core stability, Behavioral: Supervised digital training with focus on aerobic exerciseThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Low back pain> 3 months
- Age 18-50 years
- Access to computer/tablet/mobile phone
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised digital training with focus on core stabilityAfter randomization, Group 1 will be digitally supervised by experienced physiotherapist. | Behavioural | Non-supervised daily physical activity, Supervised digital training: aerobic exercise |
| Supervised digital training with focus on aerobic exerciseAfter randomization Group 2 will be digitally supervised by experienced physiotherapist. | Behavioural | Non-supervised daily physical activity, Supervised digital training: core stability |
| Non-supervised daily physical activityAfter randomization Group 3 will receive training instruction regarding daily physical activity. | Behavioural | Supervised digital training: aerobic exercise, Supervised digital training: core stability |
Primary outcome
Change in Patient-reported pain
Time frame: 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)
Change in Patient-reported pain
Time frame: 12 months compared to baseline and 6 months
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
Difference in T2 (transverse relaxation time)
Time frame: 6 months compared to baseline
MRI can characterize tissue by two different relaxation times, T1 and T2
Difference in T2 (transverse relaxation time)
Time frame: 12 months compared to baseline and 6 months
MRI can characterize tissue by two different relaxation times, T1 and T2
28 secondary outcomes
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
Change in Functional tests (Åstrand ergometer test)
Time frame: 6 months compared to baseline
Change in Functional tests (Sit-to-stand test)
Time frame: 12 months compared to baseline and 6 months
Change in Functional tests (Prone-bridge test)
Time frame: 12 months compared to baseline and 6 months
Change in Functional tests (Åstrand ergometer test)
Time frame: 12 months compared to baseline and 6 months
Change in PROM (Standardized National standardized questions on physical activity)
Time frame: 6 months compared to baseline
Change in PROM (Oswestry Low Back Disability Index)
Time frame: 6 months compared to baseline
Change in PROM (Hospital Anxiety and Depression Scale (HAD))
Time frame: 6 months compared to baseline
Change in PROM (The 5-level EQ-5D version (EQ-5D-5L))
Time frame: 6 months compared to baseline
Change in PROM (Tampa Scale of Kinesiophobia (TSK))
Time frame: 6 months compared to baseline
Change in PROM (Generalized Self-Efficacy Scale (GSES))
Time frame: 6 months compared to baseline
Change in PROM (Standardized National standardized questions on physical activity)
Time frame: 12 months compared to baseline and 6 months
Change in PROM (Oswestry Low Back Disability Index)
Time frame: 12 months compared to baseline and 6 months
Change in PROM (Hospital Anxiety and Depression Scale (HAD))
Time frame: 12 months compared to baseline and 6 months
Change in PROM (The 5-level EQ-5D version (EQ-5D-5L))
Time frame: 12 months compared to baseline and 6 months
Change in PROM (Tampa Scale of Kinesiophobia (TSK))
Time frame: 12 months compared to baseline and 6 months
Change in PROM (Generalized Self-Efficacy Scale (GSES))
Time frame: 12 months compared to baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristina Åhlund, PhD contact
Ninni IE Sernert, PhD study director
Göteborg University
Kerstin Lagerstrand, PhD study chair
Göteborg University
Helena Brisby, PhD study chair
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised digital training with focus on core stability, Supervised digital training with focus on aerobic exercise and Non-supervised daily physical activity in people with Low Back Pain, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Sivertsson, Msc (4610-435000, jenny.sivertsson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient-reported pain (time frame: 6 months compared to baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.