Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT05679167
Status:
RECRUITING
Last Update Posted:
2023-04-26
First Post:
2022-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digital Training Interventions for Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-16', 'size': 283340, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-09T04:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Both patients and physiotherapists know what intervention group they were randomized to.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three ongoing different treatments at the same time'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-25', 'studyFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2023-01-09', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Patient-reported pain', 'timeFrame': '6 months compared to baseline', 'description': '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)'}, {'measure': 'Change in Patient-reported pain', 'timeFrame': '12 months compared to baseline and 6 months', 'description': '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'}, {'measure': 'Difference in T2 (transverse relaxation time)', 'timeFrame': '6 months compared to baseline', 'description': 'MRI can characterize tissue by two different relaxation times, T1 and T2'}, {'measure': 'Difference in T2 (transverse relaxation time)', 'timeFrame': '12 months compared to baseline and 6 months', 'description': 'MRI can characterize tissue by two different relaxation times, T1 and T2'}], 'secondaryOutcomes': [{'measure': 'Change in clinical outcomes (Standing inspection)', 'timeFrame': '6 months compared to baseline', 'description': 'Normal spine curvature (yes/no)'}, {'measure': 'Change in clinical outcomes (Standing side-to-side symmetry)', 'timeFrame': '6 months compared to baseline', 'description': 'Standing side-to-side symmetry (yes/no)'}, {'measure': 'Change in Clinical outcomes (Muscle hypotrophy)', 'timeFrame': '6 months compared to baseline', 'description': 'Muscle hypotrophy (yes/no)'}, {'measure': 'Change in Clinical outcomes (Walking on heels)', 'timeFrame': '6 months compared to baseline', 'description': 'Ability to walk on heels (yes/no)'}, {'measure': 'Change in Clinical outcomes (Walking on toes)', 'timeFrame': '6 months compared to baseline', 'description': 'Ability to walk on toes (yes/no)'}, {'measure': 'Change in Clinical outcomes (Standing inspection)', 'timeFrame': '12 months compared to baseline and 6 months', 'description': 'Normal spine curvature (yes/no)'}, {'measure': 'Change in Clinical outcomes (Standing side-to-side symmetry)', 'timeFrame': '12 months compared to baseline and 6 months', 'description': 'Standing side-to-side symmetry (yes/no)'}, {'measure': 'Change in Clinical outcomes (Muscle hypotrophy)', 'timeFrame': '12 months compared to baseline and 6 months', 'description': 'Muscle hypotrophy (yes/no)'}, {'measure': 'Change in Clinical outcomes (Walking on heels)', 'timeFrame': '12 months compared to baseline and 6 months', 'description': 'Ability to walk on heels (yes/no)'}, {'measure': 'Change in Clinical outcomes (Walking on toes)', 'timeFrame': '12 months compared to baseline and 6 months', 'description': 'Ability to walk on toes (yes/no)'}, {'measure': 'Change in Functional tests (Sit-to-stand test)', 'timeFrame': '6 months compared to baseline', 'description': 'Sit-to-stand test (number of rises during 30 sec)'}, {'measure': 'Change in Functional tests (Prone-bridge test)', 'timeFrame': '6 months compared to baseline', 'description': 'Prone-bridge test (total sec)'}, {'measure': 'Change in Functional tests (Åstrand ergometer test)', 'timeFrame': '6 months compared to baseline', 'description': 'Åstrand ergometer test (estimated VO2-max, a measure of the maximum amount of oxygen your body can utilize during exercise)'}, {'measure': 'Change in Functional tests (Sit-to-stand test)', 'timeFrame': '12 months compared to baseline and 6 months', 'description': 'Sit-to-stand test (number of rises during 30 sec)'}, {'measure': 'Change in Functional tests (Prone-bridge test)', 'timeFrame': '12 months compared to baseline and 6 months', 'description': 'Prone-bridge test (total sec)'}, {'measure': 'Change in Functional tests (Åstrand ergometer test)', 'timeFrame': '12 months compared to baseline and 6 months', 'description': 'Åstrand ergometer test (estimated VO2-max)'}, {'measure': 'Change in PROM (Standardized National standardized questions on physical activity)', 'timeFrame': '6 months compared to baseline', 'description': 'Standardized National standardized questions on physical activity (grading activity in minutes/week).'}, {'measure': 'Change in PROM (Oswestry Low Back Disability Index)', 'timeFrame': '6 months compared to baseline', 'description': 'Oswestry Low Back Disability Index (0-4 No disability, 5-14 Mild disability, 15-24, Moderate disability, 25-34 Severe disability).'}, {'measure': 'Change in PROM (Hospital Anxiety and Depression Scale (HAD))', 'timeFrame': '6 months compared to baseline', 'description': 'Hospital Anxiety and Depression Scale (HAD) 0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal).'}, {'measure': 'Change in PROM (The 5-level EQ-5D version (EQ-5D-5L))', 'timeFrame': '6 months compared to baseline', 'description': '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.'}, {'measure': 'Change in PROM (Tampa Scale of Kinesiophobia (TSK))', 'timeFrame': '6 months compared to baseline', 'description': '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.'}, {'measure': 'Change in PROM (Generalized Self-Efficacy Scale (GSES))', 'timeFrame': '6 months compared to baseline', 'description': 'Generalized Self-Efficacy Scale (GSES), a 10 item self-report measure of self-efficacy, with a higher score indicating more self-efficacy.'}, {'measure': 'Change in PROM (Standardized National standardized questions on physical activity)', 'timeFrame': '12 months compared to baseline and 6 months', 'description': 'Standardized National standardized questions on physical activity (grading activity in minutes/week).'}, {'measure': 'Change in PROM (Oswestry Low Back Disability Index)', 'timeFrame': '12 months compared to baseline and 6 months', 'description': 'Oswestry Low Back Disability Index (0-4 No disability, 5-14 Mild disability, 15-24, Moderate disability, 25-34 Severe disability).'}, {'measure': 'Change in PROM (Hospital Anxiety and Depression Scale (HAD))', 'timeFrame': '12 months compared to baseline and 6 months', 'description': 'Hospital Anxiety and Depression Scale (HAD) 0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal).'}, {'measure': 'Change in PROM (The 5-level EQ-5D version (EQ-5D-5L))', 'timeFrame': '12 months compared to baseline and 6 months', 'description': '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.'}, {'measure': 'Change in PROM (Tampa Scale of Kinesiophobia (TSK))', 'timeFrame': '12 months compared to baseline and 6 months', 'description': '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.'}, {'measure': 'Change in PROM (Generalized Self-Efficacy Scale (GSES))', 'timeFrame': '12 months compared to baseline and 6 months', 'description': 'Generalized Self-Efficacy Scale (GSES), a 10 item self-report measure of self-efficacy, with a higher score indicating more self-efficacy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI', 'Physiotherapy', 'Supervised digital training'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPatients 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.\n\nA detailed description of the study protocol, see attached document.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low back pain\\> 3 months\n* Age 18-50 years\n* Access to computer/tablet/mobile phone\n\nExclusion Criteria:\n\n* 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\n* Other ongoing treatment/exercise for their low back pain\n* Patients with radiating leg pain and neurological symptoms where herniated discs are suspected\n* Previous back/neck surgery\n* Pregnancy\n* Diagnosed systematic diseases engaging the spine as rheumatoid arthritis, ankylosing spondylitis\n* Factors that prevent an MRI examination, such as claustrophobia, metal implants, etc.'}, 'identificationModule': {'nctId': 'NCT05679167', 'acronym': 'DigiLum', 'briefTitle': 'Digital Training Interventions for Low Back Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': 'Digital Training Interventions for Low Back Pain - RCT With Longitudinal Evaluation of Clinical Outcome Measures and MRI Examinations', 'orgStudyIdInfo': {'id': 'Vastra Gotaland'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Supervised digital training: core stability', 'description': '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', 'interventionNames': ['Behavioral: Supervised digital training with focus on aerobic exercise', 'Behavioral: Non-supervised daily physical activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supervised digital training: aerobic exercise', 'description': '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', 'interventionNames': ['Behavioral: Supervised digital training with focus on core stability', 'Behavioral: Non-supervised daily physical activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-supervised daily physical activity', 'description': '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.', 'interventionNames': ['Behavioral: Supervised digital training with focus on core stability', 'Behavioral: Supervised digital training with focus on aerobic exercise']}], 'interventions': [{'name': 'Supervised digital training with focus on core stability', 'type': 'BEHAVIORAL', 'description': 'After randomization, Group 1 will be digitally supervised by experienced physiotherapist.', 'armGroupLabels': ['Non-supervised daily physical activity', 'Supervised digital training: aerobic exercise']}, {'name': 'Supervised digital training with focus on aerobic exercise', 'type': 'BEHAVIORAL', 'description': 'After randomization Group 2 will be digitally supervised by experienced physiotherapist.', 'armGroupLabels': ['Non-supervised daily physical activity', 'Supervised digital training: core stability']}, {'name': 'Non-supervised daily physical activity', 'type': 'BEHAVIORAL', 'description': 'After randomization Group 3 will receive training instruction regarding daily physical activity.', 'armGroupLabels': ['Supervised digital training: aerobic exercise', 'Supervised digital training: core stability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '462 55', 'city': 'Vänersborg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Ninni Sernert, PhD', 'role': 'CONTACT', 'email': 'ninnni.sernert@vgregion.se', 'phone': '+46702274267'}, {'name': 'Kristina Åhlund, PhD', 'role': 'CONTACT', 'email': 'kristina.ahlund@hv.se'}, {'name': 'Kerstin Lagerstrand, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ninni Sernert', 'geoPoint': {'lat': 58.38075, 'lon': 12.3234}}], 'centralContacts': [{'name': 'Jenny Sivertsson, Msc', 'role': 'CONTACT', 'email': 'jenny.sivertsson@vgregion.se', 'phone': '4610-435000'}, {'name': 'Kristina Åhlund, PhD', 'role': 'CONTACT', 'email': 'kristina.ahlund@vgregion.se'}], 'overallOfficials': [{'name': 'Ninni IE Sernert, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Göteborg University'}, {'name': 'Kerstin Lagerstrand, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Göteborg University'}, {'name': 'Helena Brisby, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Göteborg University'}, {'name': 'Hanna Hebelka Bolminger, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Göteborg University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ninni Sernert', 'investigatorAffiliation': 'Vastra Gotaland Region'}}}}