Whiplash Associated Disorders (WAD)NCT02157038
Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries
A study testing Pedometer and MRI in people with Whiplash Associated Disorders (WAD) and Whiplash, run by Northwestern University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Whiplash Associated Disorders (WAD), Whiplash
- What is being tested?
- Pedometer and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Whiplash Associated Disorders (WAD), Whiplash
- Being tested
- Pedometer, MRI
- Keywords
- whiplash, neck pain, chronic pain, motor vehicle accident (MVA), car accident, Magnetic Resonance Imaging (MRI), DNA, RNA
- Medical subject headings
- Whiplash Injuries, Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PedometerDevice
MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| Procedures | Experimental | RNA/DNA blood sample will be collected. Participant will complete questionnaires, MRI and strength and reflex testing. Receives: Device: Pedometer; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Muscle Fat Expression by Magnetic Resonance Imaging (MRI)
A 2-point Dixon examination included the cervical spine (C3 to C7) and the leg. The parameters: Repetition Time (TR) = 6.59 ms, TE 1 = 2.45 ms Echo Time (TE) 2 = 3.675 ms, flip angle = 12°, Bandwidth (BW_ 1 = 510 BW 2 = 660 Hz/Px and an imaging matrix of 448 x 266. A 12-channel head coil and 4-channel neck coil was used as a receiver. A single slab was placed over the cervical spine with 36 partitions and thickness of 3mm with slab oversampling of 22% to prevent aliasing in the 3D direction. The in-plane resolution was 0.7mm with Field of View (FOV) of 320 x 190mm and 6 averages; Acquisition Time (TA) of 4:23 min. A FOV of 320-340mm was used on the lower extremity muscles using a 16-channel body array surface coil. 60 slices per slab; slice thickness 5mm and a slice oversampling of 6.7%. TA was 4:12 min, 4 averages and in-plane resolution of 0.5 mm. Analysis of the MRI was performed post hoc using customized imaging analysis programs created in MatLab (Version 2014b).
Measured: < 1 week; 2 weeks; 3 months; 1 year of motor vehicle collision (MVC)
Secondary outcomes (1)
Neck Disability Index (NDI) Questionnaire
This questionnaire will assess the influence of psychosocial factors on neck pain and disability with a range of 0 to 50, with "0" being no disability. The Neck Disability Index (NDI) is a self-reported questionnaire used to measure how neck pain affects a person's daily functioning and quality of life. It is one of the most widely used outcome measures for patients with neck disorders, including chronic neck pain, whiplash, and cervical radiculopathy.
The NDI contains 10 sections, each addressing a different aspect of daily life:
Each section is scored from:
0 = No disability 5 = Maximum disability The scores from all 10 sections are summed: Raw score range: 0-50 Percentage score: (Raw Score ÷ 50) × 100 Higher scores indicate greater disability due to neck pain. Participants were sorted into three categories based on their score: Recovered (0% to <8%), Mild (8% to <30%), and Moderate/severe (≥30%)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Whiplash Associated Disorders (WAD)Studies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- James M Elliott, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157038
- Sponsor's protocol ID
- STU00090769
- Status last verified
- May 2024
- First submitted
- 30 May 2014
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 39972963Callan 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.
PubMed 37099498Elliott 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.
PubMed 36958668Modarresi 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.
PubMed 34705736
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries
- ClinicalTrials.gov ID
- NCT02157038
- Acronym / sponsor ID
- STU00090769
- Conditions
- Whiplash Associated Disorders (WAD), Whiplash
- Keywords
- whiplash, neck pain, chronic pain, motor vehicle accident (MVA), car accident, Magnetic Resonance Imaging (MRI), DNA, RNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2014
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Posted 29 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Procedures | Experimental | Device: Pedometer, Device: MRIRNA/DNA blood sample will be collected. Participant will complete questionnaires, MRI and strength and reflex testing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pedometer | Device | Procedures |
| MRI | Device | Procedures |
Primary outcome
Number of Participants With Muscle Fat Expression by Magnetic Resonance Imaging (MRI)
Time frame: < 1 week; 2 weeks; 3 months; 1 year of motor vehicle collision (MVC)
A 2-point Dixon examination included the cervical spine (C3 to C7) and the leg. The parameters: Repetition Time (TR) = 6.59 ms, TE 1 = 2.45 ms Echo Time (TE) 2 = 3.675 ms, flip angle = 12°, Bandwidth (BW_ 1 = 510 BW 2 = 660 Hz/Px and an imaging matrix of 448 x 266. A 12-channel head coil and 4-channel neck coil was used as a receiver. A single slab was placed over the cervical spine with 36 partitions and thickness of 3mm with slab oversampling of 22% to prevent aliasing in the 3D direction. The in-plane resolution was 0.7mm with Field of View (FOV) of 320 x 190mm and 6 averages; Acquisition Time (TA) of 4:23 min. A FOV of 320-340mm was used on the lower extremity muscles using a 16-channel body array surface coil. 60 slices per slab; slice thickness 5mm and a slice oversampling of 6.7%. TA was 4:12 min, 4 averages and in-plane resolution of 0.5 mm. Analysis of the MRI was performed post hoc using customized imaging analysis programs created in MatLab (Version 2014b).
1 secondary outcome
Neck Disability Index (NDI) Questionnaire
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39972963Smith 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.
- Derived from this study: PubMed 37099498Callan 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.
- Derived from this study: PubMed 36958668Elliott 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.
- Derived from this study: PubMed 34705736Modarresi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James M Elliott, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedometer and MRI in people with Whiplash Associated Disorders (WAD) and Whiplash, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Muscle Fat Expression by Magnetic Resonance Imaging (MRI) (time frame: < 1 week; 2 weeks; 3 months; 1 year of motor vehicle collision (MVC)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02157038, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.