- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03005691
Central Sensitization in Chronic Whiplash Patients
Central Sensitization in Chronic Whiplash Patients: Metabolite Concentrations in the Anterior Cingulate Cortex and Periacueductal Gray Matter
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Diego Serrano-Muñoz, MsC
- Telefonnummer: 783 +34 925 24 77 00
- E-post: dserranomu@externas.sescam.jccm.es
Studera Kontakt Backup
- Namn: Julian Taylor-Green, PhD
- Telefonnummer: 109 +34 925 24 77 00
- E-post: jscott@sescam.org
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Tvärsnitt
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Metabolite concentrations
Tidsram: Baseline at 0 min
|
The metabolite concentrations will be measured by magnetic resonance (spectroscopy)
|
Baseline at 0 min
|
Conditioned Pain Modulation
Tidsram: Baseline at 0 min
|
Conditioned Pain Modulation will be measured by a Pathway system (Medoc Ltd)
|
Baseline at 0 min
|
Brief Pain Inventory
Tidsram: 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
Tidsram: 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
Tidsram: Baseline at 0 min
|
Pain Catastrophizing Helplessness Subscale it is used to assess the catastrophizing score
|
Baseline at 0 min
|
Neck Disability Index
Tidsram: Baseline at 0 min
|
Neck Disability Index (NDI), it is used to assess the disability after whiplash syndrome
|
Baseline at 0 min
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Diego Serrano-Muñoz, MsC, Hospital Nacional de Parapléjicos, Toledo
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GFSM-HNP
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Kronisk smärta
-
Clínica de Oftalmología de Cali S.AAvslutadMeibomisk körteldysfunktion | Eyes Dry ChronicColombia
-
Korea University Anam HospitalKorea UniversityAvslutadSmärtmätning | Visual Analog Pain Scale
-
Alanya Alaaddin Keykubat UniversityAvslutadSterilisering, Tubal | Visual Analog Pain Scale
-
Alcon ResearchAvslutad
-
Turkish Ministry of Health, Kahramanmaras Provincial...RekryteringVisual Analog Pain ScaleKalkon
-
Jules Bordet InstituteMacopharma; Belgian Hematological SocietyRekryteringRefractory Chronic Graft Versus Host Disease (cGVHD)Belgien
-
Ankara UniversityAvslutadSmärtmätning | Visual Analog Pain ScaleKalkon
-
East Carolina UniversityIndragen
-
University Hospital, GrenobleAvslutadDövhet | Visual Analog Pain ScaleFrankrike
-
Moens MaartenRekryteringMisslyckad Ryggkirurgi Syndrom | Persistent Spinal Pain Syndrome Typ 2Belgien
Kliniska prövningar på Spectroscopy
-
University of AthensRekryteringCOVID-19 lunginflammation | COVID-19 akut andnödsyndromGrekland
-
Renee CattellHar inte rekryterat ännu
-
University of MinnesotaRekrytering
-
Hospital de Clinicas de Porto AlegreOkändAttention Deficit Hyperactivity DisorderBrasilien
-
Centre Hospitalier Henri LaboritRekryteringPatienter med ultrahög risk för psykotisk övergångFrankrike
-
University Medical Center GroningenAnmälan via inbjudanJärnbrist | HF - HjärtsviktNederländerna
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, France; University... och andra samarbetspartnersAvslutadDjupa medfödda döva barn implanteradeFrankrike
-
Boston Medical CenterAmerican Cancer Society, Inc.Anmälan via inbjudan
-
Inonu UniversityAvslutadDödlig fetma | Anestesimedvetenhet | AnestesikomplikationKalkon
-
Centre Hospitalier Universitaire DijonAvslutadDiabetes typ 2Frankrike