Central Sensitization in Chronic Whiplash Patients

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03005691
• Other study ID #: GFSM-HNP
• Status: Not yet recruiting
• Phase: N/A
• First received: December 15, 2016
• Last updated: December 28, 2016
• Start date: January 2017
• Est. completion date: May 2017

Study information

• Verified date: December 2016
• Source: University of Castilla-La Mancha
• Contact: Diego Serrano-Muñoz, MsC
• Phone: +34 925 24 77 00
• Email: dserranomu[@]externas.sescam.jccm.es
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosSpain: Comité Ético de Investigación ClínicaSpain: Ministry of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Pain
• Whiplash Injuries

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Hospital Nacional de Parapléjicos de Toledo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolite concentrations	The metabolite concentrations will be measured by magnetic resonance (spectroscopy)	Baseline at 0 min	Yes
Primary	Conditioned Pain Modulation	Conditioned Pain Modulation will be measured by a Pathway system (Medoc Ltd)	Baseline at 0 min	Yes
Primary	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	Yes
Primary	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	Yes
Primary	Pain Catastrophizing Helplessness Subscale	Pain Catastrophizing Helplessness Subscale it is used to assess the catastrophizing score	Baseline at 0 min	Yes
Primary	Neck Disability Index	Neck Disability Index (NDI), it is used to assess the disability after whiplash syndrome	Baseline at 0 min	Yes