Brain Connectivity and Perceptive Surfaces in Chronic Low Back Pain (SUPER-RMNf)

NCT07568353 | Not Yet Recruiting

• 2 other identifiers: SUPER-RMNf447
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Chronic Low Back Pain (CLBP) is often associated with "cortical reorganization," where the brain's map of the back becomes less precise. This phenomenon contributes to the persistence of pain and reduced body awareness. While traditional rehabilitation focuses on the physical structure of the spine, neurocognitive approaches use "perceptive surfaces" to provide specific tactile and proprioceptive feedback, aiming to "retrain" the brain's representation of the trunk. Objective and Hypothesis: The primary goal of this study is to investigate how the brain responds to stimulation from these perceptive surfaces in patients with CLBP compared to healthy individuals. The investigators hypothesize that using these surfaces will lead to immediate changes in functional brain connectivity, particularly in areas responsible for body awareness and pain processing (somatosensory and salience networks). Study Procedures: The study will involve 20 patients with chronic non-specific low back pain and 20 healthy volunteers. All participants will undergo a Functional Magnetic Resonance Imaging (fMRI) session. During the scan, participants will be placed on a specialized perceptive surface. Brain activity and connectivity will be measured at rest and during specific tactile stimulation. Additionally, advanced imaging techniques (SANDI model) will be used to look at the microscopic structure of brain cells (neurons). Clinical Impact: By comparing the two groups, the study aims to identify specific "brain signatures" of recovery. This could help clinical professionals understand if perceptive surfaces can effectively restore cortical maps, leading to better personalized rehabilitation strategies for chronic pain.

Conditions

Low Back Pain; Healthy

Outcome Measures

Primary Outcomes (1)

• Functional Connectivity Changes in Somatosensory and Salience Networks

  Periprocedural

Secondary Outcomes (3)

• Neuronal Microstructure Mapping (SANDI model)

  Periprocedural

• Acute Pain Perception (Visual Analogue Scale)

  Day 1

• Functional Disability in CLBP Patients (Roland Morris Disability Questionnaire)

  Day 1

Other Outcomes (1)

• Brainstem Connectivity (PAG)

  Periprocedural

Study Arms (2)

CLBP Patients

EXPERIMENTAL

This arm includes 20 participants with a clinical diagnosis of non-specific chronic low back pain (duration \> 3 months). Participants undergo a clinical and functional evaluation through validated scales (VAS, RMDQ, MPQ, Waddell Index, Zung SAS/SDS, BAQ). The experimental procedure consists of a 3T MRI session including two resting-state fMRI blocks: one in a neutral condition and one while interacting with a "perceptive surface" (postural mat with sensory cones). Advanced microstructural imaging (SANDI model) is also performed.

Device: Perceptive Surface (SU-PER mat)

Healthy Controls

ACTIVE COMPARATOR

This arm includes 20 healthy volunteers, aged 18-45, without history of chronic pain. Participants undergo the same 3T MRI protocol as the clinical group (neutral vs. perceptive surface conditions) to provide a baseline for "normal" cortical representation and connectivity. Clinical evaluations for this group are limited to demographic data and the Visual Analogue Scale (VAS) for pain/discomfort monitoring during the scan.

Device: Perceptive Surface (SU-PER mat)

Interventions

Perceptive Surface (SU-PER mat) DEVICE

The intervention consists of a postural mat equipped with sensory cones of varying elastic memory and elasticity. This tool is used as a neurocognitive rehabilitation device designed to restore body perception and postural control. The device is passive, non-magnetic, and made of MRI-compatible latex (inert material). During the fMRI session, the surface is positioned so that the participant, while lying in the scanner, perceives specific plantar or trunk tactile and proprioceptive stimuli.

CLBP Patients; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 45 years
• Right-handed dominance
• Good general health condition
• Ability to provide written informed consent.
• For the patient group:
• \- Clinical diagnosis of non-specific chronic low back pain with a duration of more than 3 months
• For the control group:
• \- Healthy volunteers without a history of chronic pain

You may not qualify if:

• Contraindications to 3T Magnetic Resonance Imaging, such as pacemakers or non-compatible metallic implants
• Pregnancy or breastfeeding
• Presence of significant neurological or psychiatric pathologies
• Current use of psychoactive medications.
• Sensory or motor disorders of the lower limbs that prevent interaction with the perceptive surface.
• Unstable or acute clinical conditions.
• Inability to remain still during the MRI scanning procedure

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

ITAB - Istituto di Tecnologie Avanzate Biomediche - Università degli Studi "G. d'Annunzio"

Chieti, Chieti (CH), 66100, Italy

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Teresa Paolucci

CONTACT

+39 3278588219; teresa.paolucci@unich.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

IT (1)