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Chronic Low Back Pain: TOTALSPINE - UO04

NCT06895317 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-03-28

No results posted yet for this study

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.

Conditions

  • Chronic Low Back Pain (CLBP)

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

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Campus Bio-Medico

    collaborator OTHER

  • IRCCS Centro Neurolesi Bonino Pulejo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2025-08-31
Completion
2026-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06895317 on ClinicalTrials.gov