An interventional study of Perceptive Surface (SU-PER mat) in Low Back Pain and Healthy, sponsored by G. d'Annunzio University. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by G. d'Annunzio University · Not applicable, Interventional, and Basic science
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →G. d'Annunzio University is the lead sponsor of 67 studies on the registry; 22 are open to participants now.
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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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
Functional Connectivity Changes in Somatosensory and Salience Networks
Time frame: Periprocedural
Neuronal Microstructure Mapping (SANDI model)
Time frame: Periprocedural
Acute Pain Perception (Visual Analogue Scale)
Minimum Value: 0 Maximum Value: 10 Higher scores mean a worse outcome
Time frame: Day 1
Functional Disability in CLBP Patients (Roland Morris Disability Questionnaire)
Minimum Value: 0 Maximum Value: 24 Higher scores mean a worse outcome
Time frame: Day 1
Brainstem Connectivity (PAG)
Time frame: Periprocedural
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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G. d'Annunzio University