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Why Does Acute Post Whiplash Injury Pain Transform Into Chronic Pain?

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ClinicalTrials.gov Identifier: NCT02560675
Recruitment Status : Recruiting
First Posted : September 25, 2015
Last Update Posted : September 27, 2017
Sponsor:
Collaborators:
Technion, Israel Institute of Technology
Congressionally Directed Medical Research Programs
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:
Why does acute post whiplash injury pain transform into chronic pain? Multi-modal assessment of risk factors and predictors of pain chronification

Condition or disease
Chronic Pain Due to Injury

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 870 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Why Does Acute Post Whiplash Injury Pain Transform Into Chronic Pain? Multi-modal Assessment of Risk Factors and Predictors of Pain Chronification
Actual Study Start Date : January 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Group/Cohort
120 healthy subjects

One hundred and twenty healthy subjects (range 20-79; 20 subjects per age decade, 10 M and 10 F) will participate in the first phase of the study aimed to collect normative data from healthy population.

Study design Phase I - Normative data collection for the inhibitory and excitatory pain modulation responses, a study on healthy subjects (no blood tests)

750 subjects wuith acute whiplash-injury

Seven hundred and fifty acute whiplash-injury based mild TBI will participate in this study.

Phase II - Multi-modal assessment of acute mild TBI whiplash patients and follow-up




Primary Outcome Measures :
  1. Chronic pain [ Time Frame: 12 months ]
    acute post whiplash injury pain transform into chronic pain


Biospecimen Retention:   Samples With DNA
Blood collection for genetics. Whole blood sample (10cc) will be collected from each subject and placed in EDTA-coated tubes. Genomic DNA will be isolated using DNA Extraction Kit . Quality and quantity of the DNA sample will be measured using a NanoDrop Machine.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
750 Subjects with acute post whiplash injury pain. and 120 healthy subjects .
Criteria

Inclusion criteria:

Diagnosis of whiplash injured in road accident up to 72h before ER arrival; Glasgow coma scale 13-15 and no traumatic brain findings in computed tomography (CT); no, or shorter than 30 minutes loss of consciousness in the accident. Age 18-70, both males and females.

Exclusion criteria:

Other major bodily injuries at present accident; intracranial hemorrhage or skull fracture in present accident, prior chronic head/neck pain that requires treatment on regular basis; neurological disease that might affect performance of the tests or their interpretation such as neurodegenerative diseases; head and neck injury in past year.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02560675


Contacts
Contact: David Yarnitsky +972-4-7772605 d_yarnitsky@rambam.health.gov.il
Contact: Shiri Fadel +972-4-7771926 s_fadel@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Principal Investigator: Prof. David Yarnitsky, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Technion, Israel Institute of Technology
Congressionally Directed Medical Research Programs
Investigators
Principal Investigator: David Yarnitsky Head of Neurology department at Rambam

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02560675     History of Changes
Other Study ID Numbers: 601-14-RMB Whiplash_CTIL
597-14-RMB Gene_Whiplash_CTIL ( Other Identifier: Rambam Genetic sub study )
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017

Keywords provided by Rambam Health Care Campus:
Whiplash Injury Pain
Chronic Pain
TBI

Additional relevant MeSH terms:
Wounds and Injuries
Chronic Pain
Whiplash Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neck Injuries