Chronic PainNCT03005691
Central Sensitization in Chronic Whiplash Patients
An observational study of Chronic Pain, run by University of Castilla-La Mancha.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Spectroscopy, Questionnaires and Conditioned Pain Modulation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Whiplash syndrome
- Chronic pain
- Age between 18 to 65 years
- 4 months to 2 years after the whiplash syndrome
Who cannot join
- Neurological disease
- Claustrophobia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Chronic Pain
- Being tested
- Spectroscopy, Questionnaires, Conditioned Pain Modulation
- Keywords
- metabolite, central sensitization, whiplash
- Medical subject headings
- Chronic Pain, Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpectroscopyRadiation
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.
QuestionnairesOther
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 ModulationProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Spectroscopy; Other: Questionnaires; Procedure: Conditioned Pain Modulation | |
| 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. Receives: Radiation: Spectroscopy; Other: Questionnaires; Procedure: Conditioned Pain Modulation | |
| Non-injured | Subjects without whiplash syndrome. The inclusion criteria are defined as a absence of previous or actual symptoms or signs of neck pain. Receives: Radiation: Spectroscopy; Other: Questionnaires; Procedure: Conditioned Pain Modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolite concentrations
The metabolite concentrations will be measured by magnetic resonance (spectroscopy)
Measured: Baseline at 0 min
Conditioned Pain Modulation
Conditioned Pain Modulation will be measured by a Pathway system (Medoc Ltd)
Measured: 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.
Measured: 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.
Measured: Baseline at 0 min
Pain Catastrophizing Helplessness Subscale
Pain Catastrophizing Helplessness Subscale it is used to assess the catastrophizing score
Measured: Baseline at 0 min
Neck Disability Index
Neck Disability Index (NDI), it is used to assess the disability after whiplash syndrome
Measured: Baseline at 0 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo
- Responsible party
- Sponsor
- Investigators
- Diego Serrano-Muñoz, MsC, Principal investigator, Hospital Nacional de Parapléjicos, Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005691
- Sponsor's protocol ID
- GFSM-HNP
- Status last verified
- Dec 2016
- First submitted
- 15 Dec 2016
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: To publish in impact journals
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Sensitization in Chronic Whiplash Patients: Metabolite Concentrations in the Anterior Cingulate Cortex and Periacueductal Gray Matter
- ClinicalTrials.gov ID
- NCT03005691
- Acronym / sponsor ID
- GFSM-HNP
- Conditions
- Chronic Pain
- Keywords
- metabolite, central sensitization, whiplash
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo
- Study start
- Jan 2017
- Primary completion
- Mar 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whiplash-Pain | – | Radiation: Spectroscopy, Other: Questionnaires, Procedure: Conditioned Pain ModulationSubjects 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 | – | Radiation: Spectroscopy, Other: Questionnaires, Procedure: Conditioned Pain ModulationSubjects 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 | – | Radiation: Spectroscopy, Other: Questionnaires, Procedure: Conditioned Pain ModulationSubjects without whiplash syndrome. The inclusion criteria are defined as a absence of previous or actual symptoms or signs of neck pain. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Whiplash syndrome
- Chronic pain
- Age between 18 to 65 years
- 4 months to 2 years after the whiplash syndrome
Key exclusion criteria (2 listed)
- Neurological disease
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpectroscopySpectroscopy 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. | Radiation | Non-injured, Whiplash-Pain, Whiplash-no Pain |
| QuestionnairesQuestionnaires 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. | Other | Non-injured, Whiplash-Pain, Whiplash-no Pain |
| Conditioned Pain ModulationConditioned 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) | Procedure or surgery | Non-injured, Whiplash-Pain, Whiplash-no Pain |
Primary outcome
Metabolite concentrations
Time frame: Baseline at 0 min
The metabolite concentrations will be measured by magnetic resonance (spectroscopy)
Conditioned Pain Modulation
Time frame: Baseline at 0 min
Conditioned Pain Modulation will be measured by a Pathway system (Medoc Ltd)
Brief Pain Inventory
Time frame: Baseline at 0 min
Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference.
Neurophatic Pain Symptoms Inventory
Time frame: Baseline at 0 min
Neurophatic Pain Symptoms Inventory (NPSI), it is used to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain.
Pain Catastrophizing Helplessness Subscale
Time frame: Baseline at 0 min
Pain Catastrophizing Helplessness Subscale it is used to assess the catastrophizing score
Neck Disability Index
Time frame: Baseline at 0 min
Neck Disability Index (NDI), it is used to assess the disability after whiplash syndrome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Individual participant dataSharing planned: Yes. To publish in impact journals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Serrano-Muñoz, MsC principal investigator
Hospital Nacional de Parapléjicos, Toledo
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by University of Castilla-La Mancha.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego Serrano-Muñoz, MsC (+34 925 24 77 00 ext. 783, dserranomu@externas.sescam.jccm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolite concentrations (time frame: Baseline at 0 min). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.