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TOTALSPINE
Chronic Low Back Pain: Innovative E-healTh DiagnOstics and RehabiliTation Towards an IntegrAted and PersonaLized SPINE Care (TOTALSPINE) - UO04
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · ITALIAN MINISTRY OF HEALTH
interventional
86
1 country
2
Study Start
August 31, 2024
Actual (reported)Primary Completion
August 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Background: Low back pain (LBP) is the primary factor contributing to years lived with disability. In view of the close correlation between the functions of the body, which cannot be examined piecemeal but as an integrated system, a holistic approach allows for a comprehensive assessment of the patient. The goal of our protocol is to identify all psychosocial risk factors that could worsen the patient's condition at the time of diagnosis by examining all possible related dimensions: cognitive function, anxiety and depression, pain perception, treatment adherence, the sexual sphere, family dynamics, social support, dysfunctional communication, quality of life while also considering attribution of causes. Methods: At least 86 patients will participate in the survey. At T0, they will undergo neuropsychological, psychological and associated clinical condition assessment through standardized tests and ad hoc questionnaires. After 1 month (T1), 2 months (T2) and 6 months (T3), the same tests will be repeated. Expected results: We expect this study to provide a comprehensive, in-depth, and integrated understanding of the patient, shedding light on the challenges they may face in managing chronic low back pain. Repeated administration of the questionnaires will allow us to monitor the patient over time, assess any changes in their health status, and structure an intervention tailored to their needs. Conclusions: By emphasizing these often neglected areas through a comprehensive, multi-step assessment, it will be possible to quantify and analyze how these risk factors can affect patients' well-being and hinder the treatment process and recovery.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 31, 2024
Actual (reported)February 27, 2025
Actual (reported)March 26, 2025
Actual (reported)August 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
psychosocial assessment through the use of tests to assess the extent of pain
The Pain Self-Efficacy Questionnaire (PSEQ), will be used to assess how patients maintain their autonomy despite perceived pain. This among the various measures that will be used is considered primary outcome
At the enrollment stage before the start of treatment
Remote therapy will be delivered for the experimental group to test the effectiveness of remote physiotherapy rehabilitation
For the control group, traditional face-to-face therapy will be delivered to test the difference with remote physiotherapy rehabilitation
To develop and validate a quantitative assessment system based on wearable sensors
Compare the validity of face-to-face physiotherapy with remote physiotherapy
Irccs Centro Neurolesi Bonino Pulejo
Messina, Italy, 98124, Italy
Campus Biomedico Roma
Roma, IT, 00128, Italy
Anselmo A, Pagano M, Corallo F, Cappadona I, Cardile D, Russo F, Laudisio A, Papalia GF, Quartarone A, Calabro RS. Psychosocial Assessment as a Key Component in an Integrated, Personalized Care Pathway: A Protocol for a Low Back Pain Randomized Controlled Trial. Pain Ther. 2025 Jun;14(3):1155-1168. doi: 10.1007/s40122-025-00741-7. Epub 2025 Apr 29.
First Submitted
February 27, 2025
First Posted
March 26, 2025
Study Start
August 31, 2024
Actual (reported)Primary Completion
August 31, 2025
Estimated (date passed)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 28, 2025
Record last verified: 2024-08
The personal data (IPD) that will be collected in this study are not available openly for sensitivity reasons and are available from the clinical trial protocol scientific officer upon reasonable request.
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Source: ClinicalTrials.gov.
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