Healthy, Low Back Pain
Conditions
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.
Interventions
DEVICEPerceptive 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.
Sponsors
G. d'Annunzio University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional Connectivity Changes in Somatosensory and Salience Networks | Periprocedural |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuronal Microstructure Mapping (SANDI model) | Periprocedural | — |
| Acute Pain Perception (Visual Analogue Scale) | Day 1 | Minimum Value: 0 Maximum Value: 10 Higher scores mean a worse outcome |
| Functional Disability in CLBP Patients (Roland Morris Disability Questionnaire) | Day 1 | Minimum Value: 0 Maximum Value: 24 Higher scores mean a worse outcome |
Countries
Italy
Contacts
CONTACTTeresa Paolucci
Outcome results
None listed