Clinical Trial: Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries

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 Summary:

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.

Sponsor: Northwestern University

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Pedometer: wear for 2 consecutive weeks [ Time Frame: 2 weeks; 3 months after MVC ]
  The pedometer will record changes in activity level.
• 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.
• 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.

Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: May 30, 2014
Date Started: July 2014
Date Completion: July 2019
Last Updated: January 16, 2017
Last Verified: January 2017