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ACTIVE NOT RECRUITING
NCT06895317
NA

Chronic Low Back Pain: TOTALSPINE - UO04

Sponsor: IRCCS Centro Neurolesi Bonino Pulejo

View on ClinicalTrials.gov

Summary

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.

Official title: Chronic Low Back Pain: Innovative E-healTh DiagnOstics and RehabiliTation Towards an IntegrAted and PersonaLized SPINE Care (TOTALSPINE) - UO04

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

86

Start Date

2024-08-31

Completion Date

2026-08-31

Last Updated

2025-03-28

Healthy Volunteers

No

Interventions

BEHAVIORAL

Remote rehabilitation

To develop and validate a quantitative assessment system based on wearable sensors

BEHAVIORAL

Rehabilitation face to face

Compare the validity of face-to-face physiotherapy with remote physiotherapy

Locations (2)

Irccs Centro Neurolesi Bonino Pulejo

Messina, Italy, Italy

Campus Biomedico Roma

Roma, IT, Italy