Chronic Low Back Pain: TOTALSPINE - UO04
Unknown statusNot applicableNCT06895317
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Chronic Low Back Pain: Innovative E-healTh DiagnOstics and RehabiliTation Towards an IntegrAted and PersonaLized SPINE Care (TOTALSPINE) - UO04
- Conditions
- Interventions
- Behavioral: Remote rehabilitation
- Behavioral: Rehabilitation face to face
- Sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Collaborators
- Fondazione Policlinico Universitario Campus Bio-Medico
- Start date
- 2024-08-31
- Primary completion
- 2025-08-31
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age between 18 and 65 years; * CLBP of discogenic origin rated above 4 on the Numeric Rating Scale (NRS) in the 2 weeks prior, ongoing for the last 6 weeks up to 12 months before inclusion Exclusion Criteria: * Past or present medical history of "red flags" (e.g., cancer, fractures, infections) or specific causes of non-discogenic LBP; 2) Having received physical therapy for LBP in the last 6 months; * Previous spinal surgery; * Severe or progressive neurological deficits; * Any serious medical comorbidity that, in the opinion of the Principal Investigator (PI), would make participation unsafe or impossible
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06895317