Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries

Not Applicable

Completed

• Conditions: Whiplash Associated Disorders; WAD; Whiplash
• Interventions: Device: Pedometer; Device: MRI

• Registration Number: NCT02157038
• Lead Sponsor: Northwestern University

Brief Summary

This study is investigating whether changes in the shape and size of bodily muscles and spinal cord anatomy can influence recovery rates following a motor vehicle collision (MVC). The objective is to demonstrate that the presence of muscle and spinal cord degeneration and associated muscle weakness is the consequence of a mild MVC-related injury involving the cervical spinal cord.

Detailed Description

Whiplash is a condition that consists of patients that display varying degrees of pain and disability. Most patients should expect full-recovery within the first 2-3 months post injury. At the other end of the spectrum is a group of patients (\~ 25%) who continue to have moderate-severe pain-related disability in the long-term. Reasons for this transition to chronicity are largely unknown. The situation would benefit if there were radiological findings of the disorder. However, clear and consistent findings of injured tissues on standard radiological exams remain elusive.

As part of this study, the investigators will innovatively investigate measures to 1) quantify the temporal development of widespread muscle degeneration, 2) identify quantifiable markers of altered cervical spinal cord physiology, 3) quantify reductions in central activation and fatigue 4) evaluate potential genetic variants that may be associated with chronic pain after a MVC and 5) determine the mediational influence of psychosocial factors on recovery rates following whiplash injury, as a potential mechanism underlying the transition to chronic pain.

Study Timeline

• Study First Submitted: 2014-05-30
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-05
• Study Start: 2014-07
• Primary Completion: 2020-05
• Study Completion: 2020-05
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Males and Females (18 - 65 years of age)
• Individuals less than one week post MVA with a primary complaint of neck pain.
• Able to give written informed consent and complete interviews in English

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Exclusion Criteria

• Individuals with a spinal fracture from the MVA, or spinal surgeries
• History of one or more MVAs or previous diagnosis of cervical or lumbar radiculopathy
• History of neurological disorders (e.g. Multiple Sclerosis, previous stroke, myelopathy), inflammatory diseases (e.g. Hepatitis, Systemic Lupus Erythematosus, Rheumatoid Arthritis or Osteoarthritis, Alzheimers, Ankylosing Spondylitis, Crohn's disease, Fibromyalgia) or metabolic disorders (e.g. Diabetes, hyper- and hypo-thyroidism)
• Standard contraindications to MRI: claustrophobia, metallic implants, pacemaker and pregnancy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Procedures	MRI	RNA/DNA blood sample will be collected. Participant will complete questionnaires, MRI and strength and reflex testing.
Procedures	Pedometer	RNA/DNA blood sample will be collected. Participant will complete questionnaires, MRI and strength and reflex testing.

Primary Outcome Measures

Name	Time	Method
MRI to assess the changes in markers of altered cervical spinal cord physiology and muscle degeneration.	< 1 week; 2 weeks; 3 months; 1 year of MVC

Secondary Outcome Measures

Name	Time	Method
Pain Management Inventory (PMI) Questionnaire	< 1 week; 2 weeks; 3 months; 1 year of MVC	This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Post-traumatic Diagnostic Scale (PDS) Questionnaire	< 1 week; 2 weeks; 3 months; 1 year of MVC	This questionnaire will access the influence and psychosocial factors and recovery rates over a period of time.
Tampa Questionnaire	< 1 week; 2 weeks, 3 months; 1 year of MVC	This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Center for Epidemiological Studies - Depression Scale Questionnaire	< 1 week; 2 weeks; 3 months; 1 year of MVC	This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Hospital Anxiety and Depression Scale Questionnaire	< 1 week; 2 weeks; 3 months; 1 year of MVC	This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Traumatic Injuries Distress Scale and a Symptom Index	< 1 week; 2 weeks; 3 months; 1 year after MVC	This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Prediction of Post-MVC Chronic Axial Pain Assessment	Baseline visit	This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Follow-Up Data Collection Form for clinical prediction	2 week; 3 month; 1 year of MVC	This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Neck Disability Index (NDI) Questionnaire	<1 week; 2 weeks, 3 months; 1 year of MVC	This questionnaire will access the influence of psychosocial factors on recovery rates over a period of time.
Coping Strategy Questionnaire-C	< 1 week; 2 weeks; 3 months; 1 year of MVC	This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Impact of Events Scale Questionnaire	< 1 week; 2 weeks; 3 months; 1 year of MVC	This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
RNA and DNA blood collection	within a week of MVC	The samples will evaluate potential genetic variants that may be associated with chronic pain after a MVC.
Strength and reflex testing in the lower leg	2 weeks; 3 months; 1 year	This testing will demonstrate changes in central activation and fatigue.
Pedometer: wear for 2 consecutive weeks	2 weeks; 3 months after MVC	The pedometer will record changes in activity level.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States