Central Sensitization in Chronic Whiplash Patients
1 other identifier
observational
30
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2017
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2016
CompletedFirst Posted
Study publicly available on registry
December 29, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedDecember 29, 2016
December 1, 2016
2 months
December 15, 2016
December 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Metabolite concentrations
The metabolite concentrations will be measured by magnetic resonance (spectroscopy)
Baseline at 0 min
Conditioned Pain Modulation
Conditioned Pain Modulation will be measured by a Pathway system (Medoc Ltd)
Baseline at 0 min
Brief Pain Inventory
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
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
Pain Catastrophizing Helplessness Subscale it is used to assess the catastrophizing score
Baseline at 0 min
Neck Disability Index
Neck Disability Index (NDI), it is used to assess the disability after whiplash syndrome
Baseline at 0 min
Study Arms (3)
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.
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.
Non-injured
Subjects without whiplash syndrome. The inclusion criteria are defined as a absence of previous or actual symptoms or signs of neck pain.
Interventions
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)
Eligibility Criteria
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.
You may qualify if:
- Whiplash syndrome
- Chronic pain
- Age between 18 to 65 years
- months to 2 years after the whiplash syndrome
You may not qualify if:
- Neurological disease
- Claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diego Serrano-Muñoz, MsC
Hospital Nacional de Parapléjicos, Toledo
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2016
First Posted
December 29, 2016
Study Start
January 1, 2017
Primary Completion
March 1, 2017
Study Completion
May 1, 2017
Last Updated
December 29, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will share
To publish in impact journals