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

NCT02560675 | Completed

• 2 other identifiers: 601-14-RMB Whiplash_CTIL597-14-RMB Gene_Whiplash_CTIL
• Study Type: observational
• Target: 399
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain Due to Injury

Keywords

Whiplash Injury Pain; Chronic Pain; TBI

Outcome Measures

Primary Outcomes (1)

• Chronic pain

  acute post whiplash injury pain transform into chronic pain

  12 months

Study Arms (2)

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 with 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

750 Subjects with acute post whiplash injury pain. and 120 healthy subjects .

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• Technion, Israel Institute of Technology: collaborator
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

Location

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.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Yarnitsky

  Head of Neurology department at Rambam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: September 25, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: September 15, 2021
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

IL (1)