Low Back PainNCT07568353
Brain Connectivity and Perceptive Surfaces in Chronic Low Back Pain (SUPER-RMNf)
A study testing Perceptive Surface (SU-PER mat) in people with Low Back Pain and Healthy, run by G. d'Annunzio University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Healthy
- What is being tested?
- Perceptive Surface (SU-PER mat)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
ITAB - Istituto di Tecnologie Avanzate Biomediche - Università degli Studi "G. d'Annunzio"
Chieti, Chieti (CH), 66100
Teresa Paolucci, +39 3278588219, teresa.paolucci@unich.it
About this study
Official title: 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.
Read more
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.
- Conditions
- Low Back Pain, Healthy
- Being tested
- Perceptive Surface (SU-PER mat)
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| CLBP Patients | Experimental | 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. Receives: Device: Perceptive Surface (SU-PER mat) |
| Healthy Controls | Active comparator | 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. Receives: Device: Perceptive Surface (SU-PER mat) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Connectivity Changes in Somatosensory and Salience Networks
Measured: Periprocedural
Secondary outcomes (3)
Neuronal Microstructure Mapping (SANDI model)
Measured: Periprocedural
Acute Pain Perception (Visual Analogue Scale)
Minimum Value: 0 Maximum Value: 10 Higher scores mean a worse outcome
Measured: Day 1
Functional Disability in CLBP Patients (Roland Morris Disability Questionnaire)
Minimum Value: 0 Maximum Value: 24 Higher scores mean a worse outcome
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Paolucci, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568353
- Sponsor's protocol ID
- SUPER-RMNf
- Other IDs
- 447
- Status last verified
- Jul 2026
- First submitted
- 11 Mar 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lombalgia Cronica Aspecifica e Superfici Percettive: Rappresentazione Corticale Del Tronco Nella Risposta al Trattamento Riabilitativo - Studio Quasi-sperimentale Non Randomizzato
- ClinicalTrials.gov ID
- NCT07568353
- Acronym / sponsor ID
- SUPER-RMNf
- Conditions
- Low Back Pain, Healthy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLBP Patients | Experimental | Device: Perceptive Surface (SU-PER mat)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. |
| Healthy Controls | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Aged between 18 and 45 years
- Right-handed dominance
- Good general health condition
- Ability to provide written informed consent.
- Clinical diagnosis of non-specific chronic low back pain with a duration of more than 3 months
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | CLBP Patients, Healthy Controls |
Primary outcome
Functional Connectivity Changes in Somatosensory and Salience Networks
Time frame: Periprocedural
3 secondary outcomes
Neuronal Microstructure Mapping (SANDI model)
Time frame: Periprocedural
Acute Pain Perception (Visual Analogue Scale)
Time frame: Day 1
Functional Disability in CLBP Patients (Roland Morris Disability Questionnaire)
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perceptive Surface (SU-PER mat) in people with Low Back Pain and Healthy, run by G. d'Annunzio University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teresa Paolucci (+39 3278588219, teresa.paolucci@unich.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Connectivity Changes in Somatosensory and Salience Networks (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.