- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03005691
Central Sensitization in Chronic Whiplash Patients
Central Sensitization in Chronic Whiplash Patients: Metabolite Concentrations in the Anterior Cingulate Cortex and Periacueductal Gray Matter
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Persistent chronic pain is a common symptom of whiplash leading to reduced quality of life. Little information is available regarding changes in brain processing areas and change in central sensitization to noxious input during the chronic phase of whiplash. Metabolite concentrations in the anterior cingulate cortex and periaqueductal gray matter may be predictors of neuropathic pain and these changes may explain the development of central sensitization in people with chronic whiplash.
Until now, there is not any study that show this approach.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Yhteystiedot ja paikat
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Patients who have suffered whiplash syndrome. By one hand, patients with chronic pain (minimun 8 weeks) and 2 points or more of pain intensity. By the other hand, patiens without pain (2 points or less of pain intensity).
By last, subjects without whiplash syndrome.
Kuvaus
Inclusion Criteria:
- Whiplash syndrome
- Chronic pain
- Age between 18 to 65 years
- 4 months to 2 years after the whiplash syndrome
Exclusion Criteria:
- Neurological disease
- Claustrophobia
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: Kohortti
- Aikanäkymät: Poikkileikkaus
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
---|---|
Whiplash-Pain
Subjects with chronic whiplash syndrome and pain.
The inclusion criteria for pain include the presence of daily pain during the previous 8 weeks.
Specifically, pain will be diagnosed based on the pain intensity measured on the 0 to 10 numerical rating scale.
The minimum will be 2 points.
Subjects will be recruited between the 4 months until 2 years after the whiplash.
|
Spectroscopy is a noninvasive method to assess brain chemistry. The signal of the hydrogen atom attached to a certain molecule or metabolite has a particular frequency associated with a given metabolite. The utility of Spectroscopy is based on the fact thet the nuclei of atoms have magnetic properties that can be used to obtain chemical information regarding both the type of molecule and it is concentration. The subjects will be scanned on a 3-T Siemens system and an 12-channel phased-array coil will be used to provide an optimum signal-to-noise ratio for spectroscopy data.
Questionnaires are important to assess the chronic pain and their impact in the quality of life.
For this reason, we will assess the Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference.
Moreover, we will assess neuropathic pain symptoms with the NPSI to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain.
The catastrophizing score will be measured with the Pain Catastrophizing Helplessness Subscale.
Also,we will assess the disability after whiplash using the Neck Disability Index.
Conditioned Pain Modulation over the tenar eminence.
The test will be a heat tonic stimulus which evoke a 3-pain intensity.
The conditioning stimulus will be a cold water immersion (12ºC)
|
Whiplash-no Pain
Subjects with chronic whiplash syndrome and pain.
The inclusion criteria for pain include the ausence of daily pain during the previous 8 weeks.
Specifically, pain will be diagnosed based on the pain intensity measured on the 0 to 10 numerical rating scale.
The maximun will be 2 points.
Subjects will be recruited between the 4 months until 2 years after the whiplash.
|
Spectroscopy is a noninvasive method to assess brain chemistry. The signal of the hydrogen atom attached to a certain molecule or metabolite has a particular frequency associated with a given metabolite. The utility of Spectroscopy is based on the fact thet the nuclei of atoms have magnetic properties that can be used to obtain chemical information regarding both the type of molecule and it is concentration. The subjects will be scanned on a 3-T Siemens system and an 12-channel phased-array coil will be used to provide an optimum signal-to-noise ratio for spectroscopy data.
Questionnaires are important to assess the chronic pain and their impact in the quality of life.
For this reason, we will assess the Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference.
Moreover, we will assess neuropathic pain symptoms with the NPSI to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain.
The catastrophizing score will be measured with the Pain Catastrophizing Helplessness Subscale.
Also,we will assess the disability after whiplash using the Neck Disability Index.
Conditioned Pain Modulation over the tenar eminence.
The test will be a heat tonic stimulus which evoke a 3-pain intensity.
The conditioning stimulus will be a cold water immersion (12ºC)
|
Non-injured
Subjects without whiplash syndrome.
The inclusion criteria are defined as a absence of previous or actual symptoms or signs of neck pain.
|
Spectroscopy is a noninvasive method to assess brain chemistry. The signal of the hydrogen atom attached to a certain molecule or metabolite has a particular frequency associated with a given metabolite. The utility of Spectroscopy is based on the fact thet the nuclei of atoms have magnetic properties that can be used to obtain chemical information regarding both the type of molecule and it is concentration. The subjects will be scanned on a 3-T Siemens system and an 12-channel phased-array coil will be used to provide an optimum signal-to-noise ratio for spectroscopy data.
Questionnaires are important to assess the chronic pain and their impact in the quality of life.
For this reason, we will assess the Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference.
Moreover, we will assess neuropathic pain symptoms with the NPSI to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain.
The catastrophizing score will be measured with the Pain Catastrophizing Helplessness Subscale.
Also,we will assess the disability after whiplash using the Neck Disability Index.
Conditioned Pain Modulation over the tenar eminence.
The test will be a heat tonic stimulus which evoke a 3-pain intensity.
The conditioning stimulus will be a cold water immersion (12ºC)
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Metabolite concentrations
Aikaikkuna: Baseline at 0 min
|
The metabolite concentrations will be measured by magnetic resonance (spectroscopy)
|
Baseline at 0 min
|
Conditioned Pain Modulation
Aikaikkuna: Baseline at 0 min
|
Conditioned Pain Modulation will be measured by a Pathway system (Medoc Ltd)
|
Baseline at 0 min
|
Brief Pain Inventory
Aikaikkuna: Baseline at 0 min
|
Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference.
|
Baseline at 0 min
|
Neurophatic Pain Symptoms Inventory
Aikaikkuna: Baseline at 0 min
|
Neurophatic Pain Symptoms Inventory (NPSI), it is used to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain.
|
Baseline at 0 min
|
Pain Catastrophizing Helplessness Subscale
Aikaikkuna: Baseline at 0 min
|
Pain Catastrophizing Helplessness Subscale it is used to assess the catastrophizing score
|
Baseline at 0 min
|
Neck Disability Index
Aikaikkuna: Baseline at 0 min
|
Neck Disability Index (NDI), it is used to assess the disability after whiplash syndrome
|
Baseline at 0 min
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Diego Serrano-Muñoz, MsC, Hospital Nacional de Parapléjicos, Toledo
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- GFSM-HNP
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
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