Brain Connectivity and Perceptive Surfaces in Chronic Low Back Pain (SUPER-RMNf)
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.
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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Teresa Paolucci
- 電話番号：+39 3278588219
- メール：teresa.paolucci@unich.it
研究場所
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Chieti (CH)
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Chieti、Chieti (CH)、イタリア、66100
- ITAB - Istituto di Tecnologie Avanzate Biomediche - Università degli Studi "G. d'Annunzio"
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コンタクト：
- Teresa Paolucci
- 電話番号：+39 3278588219
- メール：teresa.paolucci@unich.it
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-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：CLBP Patients
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. |
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. |
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アクティブコンパレータ：Healthy Controls
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. |
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Functional Connectivity Changes in Somatosensory and Salience Networks
時間枠：Periprocedural
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Periprocedural
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Neuronal Microstructure Mapping (SANDI model)
時間枠：Periprocedural
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Periprocedural
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|
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Acute Pain Perception (Visual Analogue Scale)
時間枠：Day 1
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Minimum Value: 0 Maximum Value: 10 Higher scores mean a worse outcome
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Day 1
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Functional Disability in CLBP Patients (Roland Morris Disability Questionnaire)
時間枠：Day 1
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Minimum Value: 0 Maximum Value: 24 Higher scores mean a worse outcome
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Day 1
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その他の成果指標
結果測定 |
時間枠 |
|---|---|
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Brainstem Connectivity (PAG)
時間枠：Periprocedural
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Periprocedural
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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