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

Lombalgia Cronica Aspecifica e Superfici Percettive: Rappresentazione Corticale Del Tronco Nella Risposta al Trattamento Riabilitativo - Studio Quasi-sperimentale Non Randomizzato

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy; Low Back Pain
• Intervention / Treatment: Device: Perceptive Surface (SU-PER mat)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Teresa Paolucci; Phone Number: +39 3278588219; Email: teresa.paolucci@unich.it

Study Locations

• Italy
  • Chieti (CH)
    • Chieti, Chieti (CH), Italy, 66100
      • ITAB - Istituto di Tecnologie Avanzate Biomediche - Università degli Studi "G. d'Annunzio"
      • Contact: Teresa Paolucci; Phone Number: +39 3278588219; Email: teresa.paolucci@unich.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CLBP Patients; 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); 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.
Active Comparator: Healthy Controls; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional Connectivity Changes in Somatosensory and Salience Networks	Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuronal Microstructure Mapping (SANDI model)		Periprocedural
Acute Pain Perception (Visual Analogue Scale)	Minimum Value: 0 Maximum Value: 10 Higher scores mean a worse outcome	Day 1
Functional Disability in CLBP Patients (Roland Morris Disability Questionnaire)	Minimum Value: 0 Maximum Value: 24 Higher scores mean a worse outcome	Day 1

Other Outcome Measures

Outcome Measure	Time Frame
Brainstem Connectivity (PAG)	Periprocedural

Collaborators and Investigators

• Sponsor: G. d'Annunzio University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain
• Other Study ID Numbers: SUPER-RMNf; 447 (Other Identifier: Comitato Etico Regione Abruzzo (Submission ID))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No