Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries

Whiplash Clinical Trial

Official title:

Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157038
• Other study ID #: STU00090769
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: May 2020

Study information

• Verified date: January 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• WAD
• Whiplash
• Whiplash Associated Disorders
• Whiplash Injuries

Intervention

Device:
• Pedometer

• MRI

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pedometer: wear for 2 consecutive weeks	The pedometer will record changes in activity level.	2 weeks; 3 months after MVC
Secondary	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
Secondary	Strength and reflex testing in the lower leg	This testing will demonstrate changes in central activation and fatigue.	2 weeks; 3 months; 1 year