Central Sensitization in Chronic Whiplash Patients

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain
• Intervention / Treatment: Radiation: Spectroscopy; Other: Questionnaires; Procedure: Conditioned Pain Modulation

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Diego Serrano-Muñoz, MsC; Phone Number: 783 +34 925 24 77 00; Email: dserranomu@externas.sescam.jccm.es
• Study Contact Backup: Name: Julian Taylor-Green, PhD; Phone Number: 109 +34 925 24 77 00; Email: jscott@sescam.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Radiation: 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.; Other: 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.; Procedure: 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.	Radiation: 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.; Other: 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.; Procedure: 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.	Radiation: 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.; Other: 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.; Procedure: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Collaborators: Hospital Nacional de Parapléjicos de Toledo
• Investigators: Principal Investigator: Diego Serrano-Muñoz, MsC, Hospital Nacional de Parapléjicos, Toledo

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Estimate): December 29, 2016
• Last Update Submitted That Met QC Criteria: December 28, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: whiplash; metabolite; central sensitization
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Neck Injuries; Chronic Pain; Whiplash Injuries
• Other Study ID Numbers: GFSM-HNP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: To publish in impact journals

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No