- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Bern, Švýcarsko, 3010
- Dep. of Anesthesiology and Pain Therapy, Bern University Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Acute low back pain < 6 weeks
- Age 18-80
Exclusion Criteria
- History of chronic low back pain
- Radicular pain
- Pregnancy
- Breast feeding
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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All study participants
Patients With Acute Low Back Pain
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Presence or absence of chronic low back pain
Časové okno: 6 months after the acute episode
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6 months after the acute episode
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
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Mechanisms of central hypersensitivity
Časové okno: During the acute episode of low back pain
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During the acute episode of low back pain
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Michele Curatolo, MD, PhD, Dep. of Anesthesiology and Pain Therapy, Bern University Hospital
- Vrchní vyšetřovatel: Monika Müller, MD, PhD, Dep. of Anesthesiology and Pain Therapy, Bern University Hospital
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- KEK 103/08
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