ITAB - Istituto di Tecnologie Avanzate Biomediche - Università degli Studi "G. d'Annunzio"
Chieti, Chieti (CH), 66100, Italy
NCT Number: NCT07568353
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.
Trial opening soon.
Get Notified18 year–45 year
All sexes
Interventional
Not applicable
Chieti, Chieti (CH), 66100, Italy
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For the patient group:
For the control group:
Exclusion criteria
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.
Time frame: Periprocedural
Time frame: Periprocedural
Time frame: Day 1
Minimum Value: 0 Maximum Value: 10 Higher scores mean a worse outcome
Time frame: Day 1
Minimum Value: 0 Maximum Value: 24 Higher scores mean a worse outcome
Time frame: Periprocedural
Contact information is provided by the study sponsor or research team.
G. d'Annunzio University
Other
Lombalgia Cronica Aspecifica e Superfici Percettive: Rappresentazione Corticale Del Tronco Nella Risposta al Trattamento Riabilitativo - Studio Quasi-sperimentale Non Randomizzato
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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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