Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT06938568
Status:
RECRUITING
Last Update Posted:
2025-05-04
First Post:
2025-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2025-04-14', 'studyFirstSubmitQcDate': '2025-04-14', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain frequency', 'timeFrame': 'Baseline to 4, 8, 12, and 24 weeks', 'description': 'Change in number of episodes with NSLBP. Numerically, with 0 = minimum. Recall period: 7 days.'}, {'measure': 'Pain duration', 'timeFrame': 'Baseline to 4, 8, 12, and 24 weeks', 'description': 'Change in pain duration (e.g., average duration of an episode of NSLBP within the last 7 days). In minutes, hours, or days, with 0 = minimum. Recall period: 7 days.'}, {'measure': 'Pain interference (PEG)', 'timeFrame': 'Baseline to 4, 8, 12, and 24 weeks', 'description': 'Change in Pain, Enjoyment, and General Activity (PEG) 3-Item Scale. Range from 0 (no pain; does not interfere) to 10 (pain as bad as you can imagine; completely interferes). Recall period: 7 days.'}, {'measure': 'NSLBP-related work productivity loss', 'timeFrame': 'Baseline to 4, 8, 12, and 24 weeks', 'description': 'Change in Work Productivity and Activity Impairment Questionnaire (WPAI). Percentages, with 0%=no work productivity loss.'}, {'measure': 'Participant satisfaction', 'timeFrame': 'At 4, 8, 12, and 24 weeks', 'description': 'Participant satisfaction (e.g., 1. I am satisfied with the training program I received. 2. I am satisfied with the result of the training program). 4-point Likert scale (strongly agree, agree, disagree, strongly disagree).'}], 'primaryOutcomes': [{'measure': 'Self-rated physical functioning', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change in Patient-Specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 100 (able to perform at the same level as before NSLBP)'}], 'secondaryOutcomes': [{'measure': 'Self-rated physical functioning', 'timeFrame': 'Baseline to 4, 8, and 24 weeks', 'description': 'Change in Patient-Specific Functional Scale (PSFS), most bothersome activity. Range from 0 (unable to perform due to NSLBP) to 100 (able to perform at the same level as before NSLBP)'}, {'measure': 'Self-rated physical functioning (RMDQ)', 'timeFrame': 'Baseline to 4, 8, 12, and 24 weeks', 'description': 'Change in Roland Morris Disability Questionnaire (RMDQ). Range from 0 (no disability) to 24 (maximum disability).'}, {'measure': 'Health-related quality of life (EQ-VAS)', 'timeFrame': 'Baseline to 4, 8, 12, and 24 weeks', 'description': 'Change in EQ Visual Analogue Scale (EQ-VAS). Range from 0 (lowest health-related quality of life) to 100 (highest health-related quality of life).'}, {'measure': 'Health-related quality of life (EQ-5D-5L)', 'timeFrame': 'Baseline to 4, 8, 12, and 24 weeks', 'description': 'Change in 5-Level EuroQoL5D version (EQ-5D-5L). Range from 0 (lowest health-related quality of life) to 1 (highest health-related quality of life).'}, {'measure': 'Pain intensity (NRS)', 'timeFrame': 'Baseline to 4, 8, 12, and 24 weeks', 'description': 'Change in pain intensity (11-point Numeric Rating Scale, NRS). Range from 0 (no pain) to 10 (pain as bad as you can imagine). Recall period: 7 days.'}, {'measure': 'Safety outcome', 'timeFrame': 'During the 12 week intervention period', 'description': 'Number of serious adverse events (SAE) and adverse events (AE) that are deemed possibly, probably, or definitely related to the intervention (according to our protocol and ClinO, Art. 63, Switzerland).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical Functioning', 'Exercise'], 'conditions': ['Exercise Therapy', 'Low Back Pain']}, 'descriptionModule': {'briefSummary': "Personalized medicine and individualized therapeutic approaches are prominent in current research. But are these approaches also effective for treating non-specific low back pain (NSLBP)? NSLBP is one of the most common musculoskeletal issues, which can impair physical well-being, reduce the quality of life, and limit physical functioning. Additionally, it contributes to substantial direct and indirect healthcare costs, such as frequent doctor visits and work absences. Despite NSLBP being a significant burden for both individuals and society, effective alleviation methods remain unclear. The investigators' research project therefore aims to investigate whether personalized therapy, specifically a personalized physical back training program, can effectively address NSLBP. Within the context of NSLBP, the investigators' specific aim is to improve physical functioning as this outcome is considered relevant from all perspectives, including those of patients, clinical professionals, researchers, and guidelines."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Access to the University Sports of the Lucerne Universities (i.e., students, employees, alumni, subscribers)\n* NSLBP for at least 6 weeks\n* Activity limiting NSLBP (at least one activity with a PSFS Score of ≤ 50/100 on a scale from 0 = unable to perform due to NSLBP to 100 = able to perform at the same level as before NSLBP)\n* Age between 18 and 65 years\n* Understand the German language\n* Willing to participate in the study\n* Written informed consent\n\nExclusion Criteria:\n\n* Specific LBP\n* Red flags associated with any serious pathology or specific LBP,\n* Being on a waiting list for or less than 12 months post any surgery of the lower back\n* Pregnancy or given birth within the last 12 months\n* Diagnosed central neurological disease\n* Not allowed to exercise\n* Participant in the feasibility study\n* Expecting to be absent for more than 2 weeks during the intervention period'}, 'identificationModule': {'nctId': 'NCT06938568', 'acronym': 'LIFDI', 'briefTitle': 'Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universität Luzern'}, 'officialTitle': 'Personalized Physical Back Training Program to Improve Physical Functioning in People With Non-specific Low Back Pain', 'orgStudyIdInfo': {'id': '2024-01285'}, 'secondaryIdInfos': [{'id': '63674', 'type': 'OTHER_GRANT', 'domain': 'Stiftung Universität Luzern'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Personalized back exercises', 'description': 'The study intervention is a 12-week personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are selected through a clinical reasoning process, i.e., they are tailored and problem-oriented, based on the results of a clinical assessment.', 'interventionNames': ['Other: Personalized back exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-personalized back exercises', 'description': 'The active control intervention is a 12-week non-personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are not selected through a clinical reasoning process, i.e., they are neither tailored nor problem-oriented nor based on the results of a clinical assessment.', 'interventionNames': ['Other: Non-personalized back exercises']}], 'interventions': [{'name': 'Personalized back exercises', 'type': 'OTHER', 'description': "The study intervention is a 12-week personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are selected through a clinical reasoning process, i.e., they are tailored and problem-oriented, based on the results of a clinical assessment.\n\nAn initial one-on-one training session will take place to familiarize participants with the back training program, corresponding to the first week's session of the 12-week intervention period. During the 12-week intervention period, the training comprises one supervised group session per week, lasting 30 minutes, along with three individual unsupervised sessions, each lasting 10-15 minutes. Our procedures ensures that both participants and instructors are blinded to the group allocation, allowing both groups to train together (e.g., mixed training groups).", 'armGroupLabels': ['Personalized back exercises']}, {'name': 'Non-personalized back exercises', 'type': 'OTHER', 'description': "The active control intervention is a 12-week non-personalized physical back training program. It consists of six to eight exercises selected from a predefined set by a physical therapist or medical doctor. These exercises are not selected through a clinical reasoning process, i.e., they are neither tailored nor problem-oriented nor based on the results of a clinical assessment.\n\nAn initial one-on-one training session will take place to familiarize participants with the back training program, corresponding to the first week's session of the 12-week intervention period. During the 12-week intervention period, the training comprises one supervised group session per week, lasting 30 minutes, along with three individual unsupervised sessions, each lasting 10-15 minutes. Our procedures ensures that both participants and instructors are blinded to the group allocation, allowing both groups to train together (e.g., mixed training groups).", 'armGroupLabels': ['Non-personalized back exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6002', 'city': 'Lucerne', 'state': 'Canton of Lucerne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Claudio Perret, PhD', 'role': 'CONTACT', 'email': 'claudio.perret@unilu.ch', 'phone': '+41419396650'}, {'name': 'Andrea M Aegerter, PhD', 'role': 'CONTACT', 'email': 'andrea.aegerter@unilu.ch', 'phone': '+41412295739'}, {'name': 'Claudio Perret, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andrea M Aegerter, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Lucerne, Faculty of Health Sciences and Medicine, University Research Centre Health and Society', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}], 'centralContacts': [{'name': 'Claudio Perret, PhD', 'role': 'CONTACT', 'email': 'claudio.perret@unilu.ch', 'phone': '+41419396650'}, {'name': 'Andrea M Aegerter, PhD', 'role': 'CONTACT', 'email': 'andrea.aegerter@unilu.ch', 'phone': '+41412295739'}], 'overallOfficials': [{'name': 'Claudio Perret, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lucerne, University Research Centre Health and Society'}]}, 'ipdSharingStatementModule': {'timeFrame': 'It is anticipated that the data will be made available as soon as possible after the completion of the study and will remain accessible for at least 10 years.', 'ipdSharing': 'YES', 'description': 'It is anticipated that the investigators will make encrypted individual participant data (IPD) available via a data repository and, additionally, upon reasonable request to the Principal Investigator. In both cases, only data from participants who have provided informed consent for data sharing will be made available.', 'accessCriteria': 'Access to the data will be granted in accordance with the criteria of the repository and/or publisher.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Claudio Perret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Claudio Perret', 'investigatorFullName': 'Claudio Perret', 'investigatorAffiliation': 'Universität Luzern'}}}}