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Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries

Primary Purpose

Whiplash Associated Disorders, WAD, Whiplash

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pedometer
MRI
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Whiplash Associated Disorders focused on measuring whiplash, neck pain, chronic pain, motor vehicle accident, car accident, MRI, DNA, RNA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Procedures

Arm Description

RNA/DNA blood sample will be collected. Participant will complete questionnaires, MRI and strength and reflex testing.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Neck Disability Index (NDI) Questionnaire
This questionnaire will access the influence of psychosocial factors on recovery rates over a period of time.
Coping Strategy Questionnaire-C
This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Pain Management Inventory (PMI) Questionnaire
This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Tampa Questionnaire
This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Post-traumatic Diagnostic Scale (PDS) Questionnaire
This questionnaire will access the influence and psychosocial factors and recovery rates over a period of time.
Impact of Events Scale Questionnaire
This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Center for Epidemiological Studies - Depression Scale Questionnaire
This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Hospital Anxiety and Depression Scale Questionnaire
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
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
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
This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Pedometer: wear for 2 consecutive weeks
The pedometer will record changes in activity level.
RNA and DNA blood collection
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
This testing will demonstrate changes in central activation and fatigue.

Full Information

First Posted
May 30, 2014
Last Updated
January 8, 2021
Sponsor
Northwestern University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02157038
Brief Title
Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries
Official Title
Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Associated Disorders, WAD, Whiplash
Keywords
whiplash, neck pain, chronic pain, motor vehicle accident, car accident, MRI, DNA, RNA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Procedures
Arm Type
Experimental
Arm Description
RNA/DNA blood sample will be collected. Participant will complete questionnaires, MRI and strength and reflex testing.
Intervention Type
Device
Intervention Name(s)
Pedometer
Intervention Type
Device
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Neck Disability Index (NDI) Questionnaire
Description
This questionnaire will access the influence of psychosocial factors on recovery rates over a period of time.
Time Frame
<1 week; 2 weeks, 3 months; 1 year of MVC
Title
Coping Strategy Questionnaire-C
Description
This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Time Frame
< 1 week; 2 weeks; 3 months; 1 year of MVC
Title
Pain Management Inventory (PMI) Questionnaire
Description
This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Time Frame
< 1 week; 2 weeks; 3 months; 1 year of MVC
Title
Tampa Questionnaire
Description
This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Time Frame
< 1 week; 2 weeks, 3 months; 1 year of MVC
Title
Post-traumatic Diagnostic Scale (PDS) Questionnaire
Description
This questionnaire will access the influence and psychosocial factors and recovery rates over a period of time.
Time Frame
< 1 week; 2 weeks; 3 months; 1 year of MVC
Title
Impact of Events Scale Questionnaire
Description
This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Time Frame
< 1 week; 2 weeks; 3 months; 1 year of MVC
Title
Center for Epidemiological Studies - Depression Scale Questionnaire
Description
This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Time Frame
< 1 week; 2 weeks; 3 months; 1 year of MVC
Title
Hospital Anxiety and Depression Scale Questionnaire
Description
This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Time Frame
< 1 week; 2 weeks; 3 months; 1 year of MVC
Title
Traumatic Injuries Distress Scale and a Symptom Index
Description
This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Time Frame
< 1 week; 2 weeks; 3 months; 1 year after MVC
Title
Prediction of Post-MVC Chronic Axial Pain Assessment
Description
This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Time Frame
Baseline visit
Title
Follow-Up Data Collection Form for clinical prediction
Description
This questionnaire will access the influence of psychosocial factors and recovery rates over a period of time.
Time Frame
2 week; 3 month; 1 year of MVC
Title
Pedometer: wear for 2 consecutive weeks
Description
The pedometer will record changes in activity level.
Time Frame
2 weeks; 3 months after MVC
Title
RNA and DNA blood collection
Description
The samples will evaluate potential genetic variants that may be associated with chronic pain after a MVC.
Time Frame
within a week of MVC
Title
Strength and reflex testing in the lower leg
Description
This testing will demonstrate changes in central activation and fatigue.
Time Frame
2 weeks; 3 months; 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James M Elliott, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34705736
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.
Results Reference
derived

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Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries

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