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NCT Number: NCT07568353

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chieti, Chieti (CH), 66100, Italy

Location contact

Teresa Paolucci

CONTACT

[email protected]

+39 3278588219

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Functional Connectivity Changes in Somatosensory and Salience Networks

    Time frame: Periprocedural

Secondary outcomes

  1. Neuronal Microstructure Mapping (SANDI model)

    Time frame: Periprocedural

  2. Acute Pain Perception (Visual Analogue Scale)

    Time frame: Day 1

    Minimum Value: 0 Maximum Value: 10 Higher scores mean a worse outcome

  3. Functional Disability in CLBP Patients (Roland Morris Disability Questionnaire)

    Time frame: Day 1

    Minimum Value: 0 Maximum Value: 24 Higher scores mean a worse outcome

Other outcomes

  1. Brainstem Connectivity (PAG)

    Time frame: Periprocedural

Study contacts

Contact information is provided by the study sponsor or research team.

Teresa Paolucci

CONTACT

[email protected]

+39 3278588219

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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