Chronic Low Back Pain: TOTALSPINE - UO04

NCT06895317 | Active Not Recruiting

• 2 other identifiers: 181.24 CET2 cbmPNRR-MCNT2-2023-12378359
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

Chronic low back pain; quality of life; chronic pain; treatment adherence; anxiety; depression; neuropsychological; psychosocial assessment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Remote rehabilitation

EXPERIMENTAL

Remote therapy will be delivered for the experimental group to test the effectiveness of remote physiotherapy rehabilitation

Behavioral: Remote rehabilitation

Face-to-face rehabilitation

ACTIVE COMPARATOR

For the control group, traditional face-to-face therapy will be delivered to test the difference with remote physiotherapy rehabilitation

Behavioral: Rehabilitation face to face

Interventions

Remote rehabilitation BEHAVIORAL

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

Also known as: Face to face rehabilitation

Remote rehabilitation

Rehabilitation face to face BEHAVIORAL

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

Face-to-face rehabilitation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years;

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead
• Fondazione Policlinico Universitario Campus Bio-Medico: collaborator

Study Sites (2)

Irccs Centro Neurolesi Bonino Pulejo

Messina, Italy, 98124, Italy

Location

Campus Biomedico Roma

Roma, IT, 00128, Italy

Location

Related Publications (1)

• 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.

  PMID: 40299187 DERIVED

MeSH Terms

Conditions

Chronic Pain; Treatment Adherence and Compliance; Anxiety Disorders; Depression

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior; Mental Disorders; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Psychologist

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 26, 2025
• Study Start: August 31, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 28, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)