NCT06895317: TOTALSPINE

Chronic Low Back Pain: TOTALSPINE - UO04

Active, enrolled NA Last updated 28 March 2025

What this trial tests

NA trial testing Remote rehabilitation in Chronic Low Back Pain (CLBP) in 86 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

31 August 2024

Primary endpoint
31 August 2025

31 August 2026

Quick facts

Lead sponsor	IRCCS Centro Neurolesi Bonino Pulejo
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	86
Start date	31 August 2024
Primary completion	31 August 2025
Estimated completion	31 August 2026
Sites	2 locations across Italy

Drugs / interventions tested

• Remote rehabilitation
• Rehabilitation face to face

Conditions studied

• Chronic Low Back Pain (CLBP) — all drugs for Chronic Low Back Pain (CLBP) →

Sponsor

IRCCS Centro Neurolesi Bonino Pulejo — full company profile →

Who can join

Adults 18 to 65, any sex, with Chronic Low Back Pain (CLBP). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Psychosocial Assessment as a Key Component in an Integrated, Personalized Care Pathway: A Protocol for a Low Back Pain Randomized Controlled Trial.
   Anselmo A, Pagano M, Corallo F, Cappadona I, et al · · 2025 · cited 1× · PMID 40299187 · DOI 10.1007/s40122-025-00741-7