Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries

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.

Study Overview

• Status: Completed
• Conditions: Whiplash; Whiplash Associated Disorders; WAD
• Intervention / Treatment: Device: MRI; Device: Pedometer

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 Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

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

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Procedures; RNA/DNA blood sample will be collected. Participant will complete questionnaires, MRI and strength and reflex testing.	Device: MRI; Device: Pedometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: James M Elliott, PhD, Northwestern University

Publications and helpful links

General Publications

• Modarresi S, MacDermid JC, Suh N, Elliott JM, Walton DM. How Is the Probability of Reporting Various Levels of Pain 12 Months After Noncatastrophic Injuries Associated with the Level of Peritraumatic Distress? Clin Orthop Relat Res. 2022 Feb 1;480(2):226-234. doi: 10.1097/CORR.0000000000002024.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: May 30, 2014
• First Submitted That Met QC Criteria: June 4, 2014
• First Posted (Estimate): June 5, 2014

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: MRI; chronic pain; DNA; neck pain; whiplash; RNA; motor vehicle accident; car accident
• Additional Relevant MeSH Terms: Wounds and Injuries; Neck Injuries; Whiplash Injuries
• Other Study ID Numbers: STU00090769

Drug and device information, study documents

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