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Completed

NCT Number: NCT02157038

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pedometer

Device

MRI

Device

Primary outcomes

  1. MRI to assess the changes in markers of altered cervical spinal cord physiology and muscle degeneration.

    Time frame: < 1 week; 2 weeks; 3 months; 1 year of MVC

Secondary outcomes

  1. Neck Disability Index (NDI) Questionnaire

    Time frame: <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.

  2. Coping Strategy Questionnaire-C

    Time frame: < 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.

  3. Pain Management Inventory (PMI) Questionnaire

    Time frame: < 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.

  4. Tampa Questionnaire

    Time frame: < 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.

  5. Post-traumatic Diagnostic Scale (PDS) Questionnaire

    Time frame: < 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.

  6. Impact of Events Scale Questionnaire

    Time frame: < 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.

  7. Center for Epidemiological Studies - Depression Scale Questionnaire

    Time frame: < 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.

  8. Hospital Anxiety and Depression Scale Questionnaire

    Time frame: < 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.

  9. Traumatic Injuries Distress Scale and a Symptom Index

    Time frame: < 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.

  10. Prediction of Post-MVC Chronic Axial Pain Assessment

    Time frame: Baseline visit

    This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.

  11. Follow-Up Data Collection Form for clinical prediction

    Time frame: 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.

  12. Pedometer: wear for 2 consecutive weeks

    Time frame: 2 weeks; 3 months after MVC

    The pedometer will record changes in activity level.

  13. RNA and DNA blood collection

    Time frame: within a week of MVC

    The samples will evaluate potential genetic variants that may be associated with chronic pain after a MVC.

  14. Strength and reflex testing in the lower leg

    Time frame: 2 weeks; 3 months; 1 year

    This testing will demonstrate changes in central activation and fatigue.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jun 5, 2014
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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