- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00892411
Prognostic Value of Measures of the Central Hypersensitivity in Patients With Acute Low Back Pain
Prognostic Value of Measures of Central Hypersensitivity in Patients With Low Back Pain
Background. Patients with chronic low back pain display hyperexcitability of the central nervous system (central hypersensitivity). Such hypersensitivity may occur in the acute phase and represent a risk factor for the development of chronic pain.
Objective. To determine the prognostic value of central hypersensitivity for the development of chronic low back pain.
Design. Prospective cohort study.
Setting. Primary care.
Patients. 140 individuals with acute low back pain and no history of chronic pain.
Outcomes. Primary prognostic variable will be the pain tolerance threshold at the second toe (the pressure intensity at which a further increase in pressure is deemed intolerable). Exploratory secondary prognostic variables are measures of mechanisms related to central hypersensitivity: stimulus-specific hypersensitivity (pressure, electrical, heat and cold stimulation); tissue-specific hypersensitivity (skin vs. muscle stimulation); localized vs. widespread hypersensitivity; spinal cord modulation (electrophysiological measures of hypersensitivity and changes in receptive fields); modulation at brain level (descending modulation of nociceptive input and cortical plasticity). Clinical primary outcome will be the occurrence of chronic low back pain at follow-up.
Main analysis. The investigators will use least square logistic regression models to determine the association of central hypersensitivity with prognosis.
Relevance. An understanding of the prognostic value of central hypersensitivity may allow an early stratification for treatment of individuals at risk of developing chronic low back pain. Subgroups of patients may be selected for clinical trials on novel pharmacological approaches for the prevention and treatment of central hypersensitivity.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Background
Prolonged afferent nociceptive input induces an increase in the excitability of central sensory neurons and plasticity changes that cause hyperexcitability of the central nervous system (central hypersensitivity. The hyperexcitable central nervous system amplifies the nociceptive signal, thereby producing an exaggerated pain response even in the presence of limited tissue damage.
Using quantitative sensory tests, central hypersensitivity has been detected in different chronic musculoskeletal pain syndromes. Patients with chronic low back pain display increased pain sensitivity and enlargement of the areas of referred pain after stimulation of tissues around and distant from the site of pain (i.e. the leg or the thumb), suggesting that widespread central hypersensitivity is associated with this condition. Functional reorganization of the cortex has been detected in different pain conditions, including low back pain. Using equal levels of sensory stimulation in patients and pain-free controls, patients with chronic low back pain showed more extensive patterns of neuronal activation in pain-related cortical areas.
An investigation on patients after a whiplash injury found that those patients with persistent moderate or severe symptoms at 6 months had displayed, soon after injury, widespread hypersensitivity. Therefore, central hypersensitivity may be an indicator of poor prognosis. An acute peripheral lesion may induce plasticity changes leading to central hypersensitivity in a subset of individuals. Such a hypersensitivity would facilitate the transition from acute to chronic pain and disability. This hypothesis has been investigated using a limited number of tests only in a limited number of individuals with whiplash injury, but not in any other condition.
Objective
To determine the prognostic value of different measures of mechanisms of central hypersensitivity in patients with acute low back pain.
Methods
140 consecutive Patients with acute low back pain, referred by general practice, will be studied prospectively. Primary prognostic variable will be the pain tolerance threshold at the second toe (the pressure intensity at which a further increase in pressure is deemed intolerable). Exploratory secondary prognostic variables are measures of mechanisms related to central hypersensitivity: stimulus-specific hypersensitivity (pressure, electrical, heat and cold stimulation); tissue-specific hypersensitivity (skin vs. muscle stimulation); localized vs. widespread hypersensitivity; spinal cord modulation (electrophysiological measures of hypersensitivity and changes in receptive fields); modulation at brain level (descending modulation of nociceptive input and cortical plasticity). Clinical primary outcome will be the occurrence of chronic low back pain at follow-up. The investigators will use least square logistic regression models to determine the association of central hypersensitivity with prognosis.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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-
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Bern, Suisse, 3010
- Dep. of Anesthesiology and Pain Therapy, Bern University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Acute low back pain < 6 weeks
- Age 18-80
Exclusion Criteria
- History of chronic low back pain
- Radicular pain
- Pregnancy
- Breast feeding
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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All study participants
Patients With Acute Low Back Pain
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Presence or absence of chronic low back pain
Délai: 6 months after the acute episode
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6 months after the acute episode
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Mechanisms of central hypersensitivity
Délai: During the acute episode of low back pain
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During the acute episode of low back pain
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Michele Curatolo, MD, PhD, Dep. of Anesthesiology and Pain Therapy, Bern University Hospital
- Chercheur principal: Monika Müller, MD, PhD, Dep. of Anesthesiology and Pain Therapy, Bern University Hospital
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KEK 103/08
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