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Central Sensitization in Chronic Whiplash Patients

28. desember 2016 oppdatert av: University of Castilla-La Mancha

Central Sensitization in Chronic Whiplash Patients: Metabolite Concentrations in the Anterior Cingulate Cortex and Periacueductal Gray Matter

The purpose of this study is to determine whether the metabolite concentrations within the anterior cingulate cortex and periaqueductal gray matter predict the intensity and interference of neuropathic pain after the development of chronic whiplash syndrome.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

30

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Tverrsnitt

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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.
Stråling: Spectroscopy

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.

Annen: Questionnaires
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.
Fremgangsmåte: Conditioned Pain Modulation
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.
Stråling: Spectroscopy

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.

Annen: Questionnaires
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.
Fremgangsmåte: Conditioned Pain Modulation
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.
Stråling: Spectroscopy

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.

Annen: Questionnaires
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.
Fremgangsmåte: Conditioned Pain Modulation
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)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Metabolite concentrations
Tidsramme: Baseline at 0 min
The metabolite concentrations will be measured by magnetic resonance (spectroscopy)
Baseline at 0 min
Conditioned Pain Modulation
Tidsramme: Baseline at 0 min
Conditioned Pain Modulation will be measured by a Pathway system (Medoc Ltd)
Baseline at 0 min
Brief Pain Inventory
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline at 0 min
Pain Catastrophizing Helplessness Subscale it is used to assess the catastrophizing score
Baseline at 0 min
Neck Disability Index
Tidsramme: Baseline at 0 min
Neck Disability Index (NDI), it is used to assess the disability after whiplash syndrome
Baseline at 0 min

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Castilla-La Mancha

Samarbeidspartnere

Hospital Nacional de Parapléjicos de Toledo

Etterforskere

  • Hovedetterforsker: Diego Serrano-Muñoz, MsC, Hospital Nacional de Parapléjicos, Toledo

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2017

Primær fullføring (Forventet)

1. mars 2017

Studiet fullført (Forventet)

1. mai 2017

Datoer for studieregistrering

Først innsendt

15. desember 2016

Først innsendt som oppfylte QC-kriteriene

28. desember 2016

Først lagt ut (Anslag)

29. desember 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

29. desember 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. desember 2016

Sist bekreftet

1. desember 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GFSM-HNP

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

To publish in impact journals

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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