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Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries

Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02157038
Enrollment
97
Registered
2014-06-05
Start date
2014-07-31
Completion date
2020-05-31
Last updated
2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

WAD, Whiplash, Whiplash Associated Disorders

Keywords

whiplash, neck pain, chronic pain, motor vehicle accident, car accident, MRI, DNA, RNA

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.

Interventions

DEVICEPedometer
DEVICEMRI

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Northwestern University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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

MeasureTime frameDescription
Coping Strategy Questionnaire-C< 1 week; 2 weeks; 3 months; 1 year of MVCThis questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Pain Management Inventory (PMI) Questionnaire< 1 week; 2 weeks; 3 months; 1 year of MVCThis questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Tampa Questionnaire< 1 week; 2 weeks, 3 months; 1 year of MVCThis 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 MVCThis questionnaire will access the influence and psychosocial factors and recovery rates over a period of time.
Impact of Events Scale Questionnaire< 1 week; 2 weeks; 3 months; 1 year of MVCThis 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 MVCThis 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 MVCThis questionnaire will access the influence of psychosocial factors on recovery rates over a period of time.
Traumatic Injuries Distress Scale and a Symptom Index< 1 week; 2 weeks; 3 months; 1 year after MVCThis questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Prediction of Post-MVC Chronic Axial Pain AssessmentBaseline visitThis questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Follow-Up Data Collection Form for clinical prediction2 week; 3 month; 1 year of MVCThis questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Pedometer: wear for 2 consecutive weeks2 weeks; 3 months after MVCThe pedometer will record changes in activity level.
RNA and DNA blood collectionwithin a week of MVCThe samples will evaluate potential genetic variants that may be associated with chronic pain after a MVC.
Strength and reflex testing in the lower leg2 weeks; 3 months; 1 yearThis testing will demonstrate changes in central activation and fatigue.
Hospital Anxiety and Depression Scale Questionnaire< 1 week; 2 weeks; 3 months; 1 year of MVCThis questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026