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Pathophysiological Mechanism Behind Prolonged Whiplash Associated Disorders

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ClinicalTrials.gov Identifier: NCT03664934
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Anneli Peolsson, Linkoeping University

Brief Summary:
The knowledge of pathophysiological mechanisms behind prolonged Whiplash Associated Disorders (WAD) is insufficient and whether changes can be restored by rehabilitation or not is unknown. The aim of these studies are to investigate different parameters to further learn about pathophysiological mechanisms (neck muscle fatty infiltration, cross-sectional area, volume, inflammation and function, brain structure and activity, biomarkers for stress and inflammation, cervical kinaesthesia and balance before and after intervention) and the association for clinical outcomes in individuals with chronic WAD (n=30) compared with age and gender matched healthy individuals (n=30). Measurements will be made at baseline (patients and healthy) and at 3 months (patients only, at the end of treatment). However, for the blood and saliva samples, they will be re-investigated in the healthy group as well. The study results may contribute to the development of improved understanding and diagnostics in chronic WAD that may improve future rehabilitation.

Condition or disease Intervention/treatment Phase
Whiplash Injuries Other: Exercises Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessor blinded if a patient or a healthy control
Primary Purpose: Diagnostic
Official Title: Pathophysiological Mechanism Behind Prolonged Whiplash Associated Disorders
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients, Neck-specific exercises
Patients before and after neck-specific exercises, subgroup to NCT01528579 with additional measures
Other: Exercises
Neck-specific exercises for chronic whiplash associated disorders
Other Name: No treatment, controls only

No Intervention: Healthy controls
Healthy controls, no treatment



Primary Outcome Measures :
  1. Speckle tracking analyses of neck and shoulder muscle function [ Time Frame: Baseline and at 3 months follow-up when intervention ended. The outcome measure is going to report a change over time for patients. ]
    Measured with medical ultrasonography during neck and arm exercises

  2. Cross-sectional area, volume, fatty infiltration and inflammation of neck muscles [ Time Frame: Baseline, 3 months. The outcome measure is going to report a change over time for patients. ]
    Neck and some whole body imaging measured with 3.0 T MRI scanner

  3. Brain function in cortical networks related to pain [ Time Frame: Baseline, 3 months. The outcome measure is going to report a change over time for patients. ]
    Measured with a resting-state fMRI protocol with an echo planar imaging (EPI) sequence

  4. Biomarkers for inflammation and stress [ Time Frame: Baseline, 3 months. The outcome measure is going to report a change over time for patients. ]
    Measured with blood samples and saliva

  5. Cervikal kinaesthesia [ Time Frame: Baseline, 3 months. The outcome measure is going to report a change over time for patients. ]
    Neck-eye coordination

  6. Balance test [ Time Frame: Baseline, 3 months. The outcome measure is going to report a change over time for patients. ]
    Postural sway during single and double leg stance


Secondary Outcome Measures :
  1. Neck Disability Index (NDI) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Self-reported neck-specific function. Score 0 to 50 (or in percentages 0% to 100%); 0p/0%=no disability, 50p/100%=complete activity limitation

  2. Whiplash Disability Questionnaire [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Disability associated with whiplash, in patients. Score 0 to 130; 0=no disability, 130=maximum disability.

  3. Patient-specific functional scale (PSFS) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Individual ratings of function to quantify activity limitations, in patients. Score 0-10 score; 0= Unable to perform activity, 10= Able to perform activity at the same level as before injury or problem. Total score=sum of the activity scores/ number of activities.

  4. Pain intensity in neck, head, and arm and dizziness by a Visual Analogue Scale (VAS) (0-100 mm; where 0=no pain, 100= worst imaginable pain ) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Pain intensity. Score 0 to 100 mm; 0=no pain, 100=worst imaginable pain

  5. Distribution of pain by a pain drawing assessed with images [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Distribution of pain, in patients

  6. Frequency of pain [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Frequency of pain, in patients

  7. Use of pain medications [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Use of pain medications, in patients

  8. Dizziness/balance by the Dizziness Handicap Inventory (DHI) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Dizziness questionnaire, in patients

  9. Headache Questions by VAS and the Headache Impact Test (HIT-6) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Impact of headache, in patients

  10. Pain Catastrophizing Scale (PCS), total scores range from 0 - 52; 0=no catastrophizing, 52= maximum catastrophizing [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Self-reported pain catastrophizing, in patients

  11. EuroQuol five dimensions [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Self-reported health, in patients

  12. Effort Reward Imbalance questionnaire [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Work related balance between effort and reward, in patients

  13. Symptoms Satisfaction scale [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Satisfaction with present symptoms, in patients. 1 to 7 scale; 1=delighted, 7=terrible.

  14. Physical activity score, a combination score of the 2 questions (everyday physical activity and exercise/sport/open-air activity) to a combined 4-point score [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Physical activity. Score 0 to 4; 0=inactivity, 4=high activity.

  15. Health care consumption, number of visits [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Health care consumption, in patients

  16. Self-Efficacy Scale (SES) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Self-reported self-efficacy, in patients. Score 0-200; 0=no self-efficacy, 200=strong self-efficacy

  17. Fear Avoidance Beliefs Questionnaire (FABQ) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Fear Avoidance Beliefs, in patients

  18. Hospital Anxiety and Depression Scale (HAD) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Depression and anxiety. Each subscale (depression and anxiety) range from 0 to 21; 0=normal, 21=severe

  19. Post Traumatic Stress Disorder checklist (PCL-S) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Post Traumatic Stress, in patients

  20. Range of neck motion [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Range of motion, in patients

  21. Ergonomics questions and how work is perceived [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Work ergonomics, in patients

  22. Sickness presence by the Stanford presenteeism scale (SPS-6) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Sickness presence at work, impact of health problems on individual work performance and overall perceived productivity , in patients. Scores 6-30, with lower scores indicting lower Presenteeism, and higher scores indicating higher Presenteeism.

  23. Patient Enablement Instrument (PEI) questionnaire [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Patient enablement, in patients

  24. Consumption of analgesic drugs prescribed through the drug registry [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Consumption of analgesic drugs, in patients

  25. Sick-leave registration, number of days and episodes [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Sick-leave, in patients

  26. Cognitive failures questionnaire (CFQ) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Cognitive function, in patients

  27. Sensorimotor control of the neck muscles, mm Hg [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Sensorimotor control, in patients

  28. Neck muscle endurance of ventral and dorsal neck muscles in seconds [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Neck muscle endurance, in patients

  29. Balance measured in seconds, standing on one leg with eyes closed [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Balance, in patients

  30. Neurology [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Clinical examination of neurology, in patients, such as reflexes, sensibility, muscle weakness, Spurling´s test, neural tension test.

  31. Work Ability Index (WAI) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Self-reported work ability, in patients

  32. Global rating of change scale [ Time Frame: Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up ]
    Overall change because of the treatment, in patients. Score -5 (very much worse to +5 completely recovered and importance of change 0=not at all important, 100= very important.


Other Outcome Measures:
  1. Background data such as age and gender, living circumstances [ Time Frame: Baseline ]
    Background data such as age, gender, living circumstances



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 63 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Study population

The inclusion criteria for patients are:

  • Chronic neck problems corresponding to WAD grades 2-3 verified by clinical examination
  • Average estimated pain in the last week at least 20 mm on the visual analogue scale (VAS)
  • Neck disability of more than 20% on the Neck Disability Index (NDI) [10]
  • Working age (18 - 63 years)
  • Daily access to a computer/tablet/smart phone and Internet
  • Neck symptoms within the first week after the injury (i.e., neck pain, neck stiffness, or cervical radiculopathy).

For the present sub group study additional criteria were:

  • Right handed
  • Dominant right sided or equal sided pain

Inclusion criteria for healthy controls:

• Age and gender matched healthy individuals without neck pain and disability (VAS <10mm, NDI <5%) that feel overall healthy without known diseases.

Exclusion criteria for patients:

  • Individuals with any of the following signs of head injury at the time of whiplash injury will be excluded: loss of consciousness, amnesia before or after the injury, altered mental status (e.g., confusion, disorientation), focal neurological changes (changes in smell and taste).
  • Previous fractures or dislocation of the cervical spine
  • Known or suspected serious physical pathology included myelopathy,
  • Spinal tumours
  • Spinal infection
  • Ongoing malignancy
  • Previous severe neck problems that resulted in sick leave for more than a month in the year before the current whiplash injury
  • surgery in the cervical spine
  • Generalized or more dominant pain elsewhere in the body
  • Other illness/injury that may prevent full participation
  • Inability to understand and write in Swedish

Additional criteria in the present sub group:

  • Increased risk of bleeding,
  • BMI >35
  • Contraindications of MRI such as metal, severe obesity, pacemaker and pregnancy.

Exclusion criteria for healthy controls:

  • Earlier neck injury,
  • Recurrent neck pain,
  • Earlier treatment for neck pain.
  • Increased risk of bleeding,
  • BMI >35
  • Contraindications of MRI such as metal, severe obesity, pacemaker and pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664934


Contacts
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Contact: Anneli Peolsson, Professor +46-013284601 Anneli.Peolsson@liu.se
Contact: Gunnel Peolsson, PhD +46-13284601 Anneli.Peolsson@liu.se

Locations
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Sweden
Linköping University Recruiting
Linköping, Östergötland, Sweden, 58183
Contact: Anneli Peolsson, Professor    +46-13284601    Anneli.Peolsson@liu.se   
Contact: Gunnel Peterson, PhD       Gunnel.Peterson@liu.se   
Principal Investigator: Anneli Peolsson, PhD         
Principal Investigator: Gunnel Peterson, PhD         
Sub-Investigator: Tino Ebbers, PhD         
Sub-Investigator: Bijar Ghafouri, PhD         
Sub-Investigator: Magnus Borga, PhD         
Sub-Investigator: Tobias Romu, PhD         
Sub-Investigator: Anette Karlsson, MSc         
Sub-Investigator: Maria Engström, PhD         
Sub-Investigator: Eythor Kristjansson, PhD         
Sub-Investigator: Hilla Sarig Bahat, PhD         
Sub-Investigator: Dimetry German, PhD         
Sponsors and Collaborators
Linkoeping University
Investigators
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Principal Investigator: Anneli Peolsson, Professor Linkoeping University
  Study Documents (Full-Text)

Documents provided by Anneli Peolsson, Linkoeping University:
Statistical Analysis Plan  [PDF] August 31, 2018
Study Protocol  [PDF] August 31, 2018
Informed Consent Form  [PDF] September 6, 2018


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anneli Peolsson, Professor, PhD, PT, Linkoeping University
ClinicalTrials.gov Identifier: NCT03664934     History of Changes
Other Study ID Numbers: Linköping University
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anneli Peolsson, Linkoeping University:
Neck pain, Rehabilitation, Muscles, Clinical Trial,
Diagnostics

Additional relevant MeSH terms:
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Whiplash Injuries
Neck Injuries
Wounds and Injuries