Pathophysiological Mechanism Behind Prolonged Whiplash Associated Disorders

NCT03664934 | Completed

• 1 other identifier: Linköping University
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Whiplash Injuries

Keywords

Neck pain, Rehabilitation, Muscles, Clinical Trial,; Diagnostics

Outcome Measures

Primary Outcomes (6)

• Speckle tracking analyses of neck and shoulder muscle function

  Measured with medical ultrasonography during neck and arm exercises

  Baseline and at 3 months follow-up when intervention ended. The outcome measure is going to report a change over time for patients.

• Cross-sectional area, volume, fatty infiltration and inflammation of neck muscles

  Neck and some whole body imaging measured with 3.0 T MRI scanner

  Baseline, 3 months. The outcome measure is going to report a change over time for patients.

• Brain function in cortical networks related to pain

  Measured with a resting-state fMRI protocol with an echo planar imaging (EPI) sequence

  Baseline, 3 months. The outcome measure is going to report a change over time for patients.

• Biomarkers for inflammation and stress

  Measured with blood samples and saliva

  Baseline, 3 months. The outcome measure is going to report a change over time for patients.

• Cervikal kinaesthesia

  Neck-eye coordination

  Baseline, 3 months. The outcome measure is going to report a change over time for patients.

• Balance test

  Postural sway during single and double leg stance

  Baseline, 3 months. The outcome measure is going to report a change over time for patients.

Secondary Outcomes (32)

• Neck Disability Index (NDI)

  Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up

• Whiplash Disability Questionnaire

  Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up

• Patient-specific functional scale (PSFS)

  Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up

• 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 )

  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 by a pain drawing assessed with images

  Change from baseline to 3 months (the end of treatment) and 15 months (1 year after study treatment is finalized) follow-up

Other Outcomes (1)

• Background data such as age and gender, living circumstances

  Baseline

Study Arms (2)

Patients, Neck-specific exercises

EXPERIMENTAL

Patients before and after neck-specific exercises, subgroup to NCT01528579 with additional measures

Other: Exercises

Healthy controls

NO INTERVENTION

Healthy controls, no treatment

Interventions

Exercises OTHER

Neck-specific exercises for chronic whiplash associated disorders

Also known as: No treatment, controls only

Patients, Neck-specific exercises

Eligibility Criteria

• Age: 18 Years - 63 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linköping University

Linköping, Östergötland County, 58183, Sweden

Location

Related Publications (2)

• Ragnarsdottir H, Peterson G, Gislason MK, Oddsdottir GL, Peolsson A. The effect of a neck-specific exercise program on cervical kinesthesia for patients with chronic whiplash-associated disorders: a case-control study. BMC Musculoskelet Disord. 2024 May 2;25(1):346. doi: 10.1186/s12891-024-07427-9.

  PMID: 38693515 DERIVED

• Peolsson A, Karlsson A, Ghafouri B, Ebbers T, Engstrom M, Jonsson M, Wahlen K, Romu T, Borga M, Kristjansson E, Bahat HS, German D, Zsigmond P, Peterson G. Pathophysiology behind prolonged whiplash associated disorders: study protocol for an experimental study. BMC Musculoskelet Disord. 2019 Feb 2;20(1):51. doi: 10.1186/s12891-019-2433-3.

  PMID: 30711003 DERIVED

MeSH Terms

Conditions

Whiplash Injuries; Neck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anneli Peolsson, Professor

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor blinded if a patient or a healthy control
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD, PT

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 11, 2018
• Study Start: October 4, 2018
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: October 3, 2023

Record last verified: 2023-10

Locations

SE (1)