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Neck-specific Exercise in Chronic Whiplash

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ClinicalTrials.gov Identifier: NCT03022812
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Anneli Peolsson, Linkoeping University

Brief Summary:
Neck pain is fourth among the most common conditions worldwide associated with longer periods of living with disability. Annually, about 30 000 people in Sweden undergo a whiplash trauma (WAD), and half of those individuals will develop chronic problems with high costs for the individual and society. Evidence for chronic WAD treatment is scarce, although neck-specific training at a physiotherapy clinic (2 times a week for 3 months) has demonstrated good results. A more efficient, flexible rehabilitation with reduced waiting times and lower costs is needed, ideally replacing lengthy on-site treatment series by health care providers. Internet-based care has proven to be a viable alternative to personal care meetings for a variety of diseases and interventions, but studies are lacking on Internet-based interventions for individuals with chronic neck problems. The purpose of this study is to investigate if A) neck-specific training delivered through Internet-based care differs from B) a longer series of treatments at a physiotherapy clinic regarding, e.g., work ability, sick-leave and disability. This prospective, randomized study involves 140 participants. Measurement is done at baseline, 3 months (end of treatment), and 15 months (12 months after end of treatment in the study) and will include ratings of work ability, sick-leave, work presenteeism, disability, pain, health, satisfaction with care, quality of life, and cost-effectiveness. The study results may contribute to the development of a more effective rehabilitation, flexible and equal care, shorter waiting times, increased availability and lower costs for health care and society. The program can be implemented on a broader scale in neck pain patients.

Condition or disease Intervention/treatment Phase
Whiplash Associated Disorders Other: Neck-specific exercise Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is E-health a Way to Increase Ability and Health and Make Health Care More Effective in Chronic Whiplash? A Prospective Randomized Controlled Multicenter Trial
Actual Study Start Date : April 6, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Exercises at a physiotherapy clinic
Neck-specific exercise at a physiotherapy clinic, 24 times during 12 weeks (plus an additional first visit).
Other: Neck-specific exercise
Neck-specific exercise

Experimental: Exercises with Internet support
Neck-specific exercise with Internet support combined with 3 visits at a physiotherapy clinic (plus an additional first visit), exercises mainly performed outside the health care system during 12 weeks.
Other: Neck-specific exercise
Neck-specific exercise




Primary 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Pain intensity in neck, head, and arm and dizziness by a VAS (0-100 mm) [ 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Pain Catastrophizing 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 ]
    Self-reported pain catastrophizing

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. Hospital Anxiety and Depression 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 ]
    Depression and anxiety

  18. Post Traumatic Stress Disorder checklist (PCL-S) [ Time Frame: Baseline ]
    Post Traumatic Stress

  19. 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

  20. 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

  21. Sickness presence by the Stanford presenteeism 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 ]
    Sickness presence at work

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

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

  30. Ultrasound registrations may be measured in a sub-group, deformation and deformation rate [ Time Frame: Change from baseline to 3 months follow-up ]
    Neck muscle function

  31. MRI may be measured in a sub-group. [ Time Frame: Change from baseline to 3 months follow-up ]
    Neck muscle structure and maybe function


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

  2. 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

  3. Global rating of change scale [ Time Frame: Change from baseline to 3 months and 15 months follow-up, measured at follow-ups ]
    overall change because of the treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 63 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals with a whiplash injury in a traffic accident with a four-wheeled motor vehicle at least 6 months ago but less than 5 years ago, with chronic neck problems corresponding to Quebec Task Force (QTF) grades 2-3 verified in clinical examination
  • No participation in a neck-specific exercise program in a previous research study;
  • Average estimated pain in the preceding week more than 20 mm on the visual analogue scale (VAS)
  • Neck disability for more than 20% of the Neck Disability Index
  • Working age, between 18 and 63 years
  • Daily access to computer/tablet/smart phone and Internet
  • Time to follow the treatment program
  • Neck symptoms within the first week after the injury (neck pain, neck stiffness, or radiculopathy from the neck).

Exclusion Criteria:

  • Any of the following signs of brain damage at the time of injury: 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 column
  • Known or suspected serious physical pathology included myelopathy, spinal tumours, spinal infection, or 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 column
  • Generalized or more dominant pain elsewhere in the body
  • Other illness/injury that may prevent full participation in the study and/or where neck exercises are contraindicated
  • Inability to understand and write in Swedish
  • Diagnosed severe mental illness, e.g., psychosis, schizophrenia, personality disorders
  • Current alcohol or drug abuse.

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): NCT03022812


Contacts
Contact: Anneli Peolsson, Professor +46-13284601 Anneli.Peolsson@liu.se
Contact: Gunnel Peterson, PhD +46-730660518 Gunnel.Peterson@liu.se; Gunnel.Peterson@dll.se

Locations
Sweden
Anneli Peolsson Recruiting
Linköping, Sweden, 58929
Contact: Anneli Peolsson    13284601    Anneli.Peolsson@liu.se   
Sponsors and Collaborators
Linkoeping University
Investigators
Principal Investigator: Anneli Peolsson, Professor Dep. Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden
Study Chair: Gunnel Peterson, PhD Dep. Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden
Study Chair: Maria Landén Ludvigsson, PhD Dep. Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anneli Peolsson, Professor, PhD, PT, Linkoeping University
ClinicalTrials.gov Identifier: NCT03022812     History of Changes
Other Study ID Numbers: 2016/135-31
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Exercise Therapy
Internet

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