NCT02157038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

5.8 years

First QC Date

May 30, 2014

Last Update Submit

January 8, 2021

Conditions

Whiplash Associated DisordersWADWhiplash

Keywords

whiplashneck painchronic painmotor vehicle accidentcar accidentMRIDNARNA

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Neck Disability Index (NDI) Questionnaire

    <1 week; 2 weeks, 3 months; 1 year of MVC

  • Coping Strategy Questionnaire-C

    < 1 week; 2 weeks; 3 months; 1 year of MVC

  • Pain Management Inventory (PMI) Questionnaire

    < 1 week; 2 weeks; 3 months; 1 year of MVC

  • Tampa Questionnaire

    < 1 week; 2 weeks, 3 months; 1 year of MVC

  • Post-traumatic Diagnostic Scale (PDS) Questionnaire

    < 1 week; 2 weeks; 3 months; 1 year of MVC

  • +9 more secondary outcomes

Study Arms (1)

Procedures

EXPERIMENTAL

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

Device: PedometerDevice: MRI

Interventions

PedometerDEVICE
Procedures
MRIDEVICE
Procedures

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

  • Smith AC, Laguna JM, Wesselink EO, Scott ZE, Jenkins H, Thornton WA, Wasielewski M, Connor J, Delp S, Chaudhari AS, Parrish TB, Mackey S, Elliott JM, Weber KA 2nd. Leg Muscle Volume, Intramuscular Fat and Force Generation: Insights From a Computer-Vision Model and Fat-Water MRI. J Cachexia Sarcopenia Muscle. 2025 Feb;16(1):e13735. doi: 10.1002/jcsm.13735.

    PMID: 39972963DERIVED

  • Callan B, Walton DM, Cleland J, Kolber MJ, Elliott JM. Exploring sex as a moderator of other prognostic variables in whiplash associated disorder: An observational study. PLoS One. 2023 Apr 26;18(4):e0282640. doi: 10.1371/journal.pone.0282640. eCollection 2023.

    PMID: 37099498DERIVED

  • Elliott JM, Walton DM, Albin SR, Courtney DM, Siegmund GP, Carroll LJ, Weber KA 2nd, Smith AC. Biopsychosocial sequelae and recovery trajectories from whiplash injury following a motor vehicle collision. Spine J. 2023 Jul;23(7):1028-1036. doi: 10.1016/j.spinee.2023.03.005. Epub 2023 Mar 21.

    PMID: 36958668DERIVED

  • 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.

    PMID: 34705736DERIVED

MeSH Terms

Conditions

Whiplash InjuriesNeck PainChronic Pain

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • James M Elliott, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 30, 2014

First Posted

June 5, 2014

Study Start

July 1, 2014

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

US(1)