Clinical trial NCT02157038: Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries
Official title: Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Whiplash Associated Disorders
WAD
Whiplash
Keywords: whiplash
neck pain
chronic pain
motor vehicle accident
car accident
MRI
DNA
RNA
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-06-05
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MRI to assess the changes in markers of altered cervical spinal cord physiology and muscle degeneration.
timeFrame: < 1 week; 2 weeks; 3 months; 1 year of MVC
Secondary outcomes:
measure: Neck Disability Index (NDI) Questionnaire
timeFrame: <1 week; 2 weeks, 3 months; 1 year of MVC
measure: Coping Strategy Questionnaire-C
timeFrame: < 1 week; 2 weeks; 3 months; 1 year of MVC
measure: Pain Management Inventory (PMI) Questionnaire
timeFrame: < 1 week; 2 weeks; 3 months; 1 year of MVC
measure: Tampa Questionnaire
timeFrame: < 1 week; 2 weeks, 3 months; 1 year of MVC
measure: Post-traumatic Diagnostic Scale (PDS) Questionnaire
timeFrame: < 1 week; 2 weeks; 3 months; 1 year of MVC
measure: Impact of Events Scale Questionnaire
timeFrame: < 1 week; 2 weeks; 3 months; 1 year of MVC
measure: Center for Epidemiological Studies - Depression Scale Questionnaire
timeFrame: < 1 week; 2 weeks; 3 months; 1 year of MVC
measure: Hospital Anxiety and Depression Scale Questionnaire
timeFrame: < 1 week; 2 weeks; 3 months; 1 year of MVC
measure: Traumatic Injuries Distress Scale and a Symptom Index
timeFrame: < 1 week; 2 weeks; 3 months; 1 year after MVC
measure: Prediction of Post-MVC Chronic Axial Pain Assessment
timeFrame: Baseline visit
measure: Follow-Up Data Collection Form for clinical prediction
timeFrame: 2 week; 3 month; 1 year of MVC
measure: Pedometer: wear for 2 consecutive weeks
timeFrame: 2 weeks; 3 months after MVC
measure: RNA and DNA blood collection
timeFrame: within a week of MVC
measure: Strength and reflex testing in the lower leg
timeFrame: 2 weeks; 3 months; 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: James M Elliott, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.