Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries

NCT ID: NCT02157038

Last Updated: 2021-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2020-05-31

Brief Summary

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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

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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.

Conditions

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Whiplash Associated Disorders WAD Whiplash

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Procedures

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

Group Type EXPERIMENTAL

Pedometer

Intervention Type DEVICE

MRI

Intervention Type DEVICE

Interventions

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Pedometer

Intervention Type DEVICE

MRI

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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James Elliott

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James M Elliott, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39972963 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37099498 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36958668 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34705736 (View on PubMed)

Other Identifiers

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STU00090769

Identifier Type: -

Identifier Source: org_study_id

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