Validating a Brief Screening Tool With Biomarkers for Prediction of Chronic Post Traumatic Neck Pain

NCT06176209 | Not Yet Recruiting

• 1 other identifier: 106498
• Study Type: observational
• Target: 155
• Locations: 0 countries
• Sites: N/A

Brief Summary

Early screening of posttraumatic neck pain after accidents \- A clinical prediction tool with biomarkers predicting chronic posttraumatic neck pain. The goal of this prospective cohort study is to develop a clinical prediction tool with biomarkers for early prediction of chronic posttraumatic neck pain. Aims:

1. 1.validate and further develop an existing prediction and screening tool for post traumatic neck pain using biomarkers for stress (i.e. HRV). The investigators hypothesize that the addition of a HRV to the existing screening and prediction tool in the acute phase (i.e. \< 72 hours) post-accident can contribute to better and earlier identification of high-risk patients who continue to experience moderate to high degree of impairment after 12 months (i.e. NDI \>32%).
2. 2.examine whether the health economic costs for the group that does not improve are greater after 12 months. The investigators hypothesize that the health economic costs for the group that does not improve are greater after 12 months (labour market attachment and health services) compared to those who improve (NDI score \< 10% vs. \> 32%).
3. 3.evaluate the role of low HRV on the development of PTSD 3 month after the accident. the hypothesis is that low HRV is a predictor of the development of PTSD.3 month after an accident.
4. 4.Evaluate whether PTSD mediates the association between low HRV and pain sensitization 3 months after the accident. The investigators hypothesize that the development of pain sensitivity 3 month after an accident is associated with low HRV and PTSD.

Conditions

Neck Pain Following Traffic Accident

Keywords

Heart rate variability; Hyperarousal; Whiplash; Posttraumatic Stress Symptom; Neck Pain; Biomarkers; Hair cortisol

Outcome Measures

Primary Outcomes (5)

• Neck disability index

  Neck pain and disability

  72 hours after accident

• Neck disability index

  Neck pain and disability

  1 week after accident

• Neck disability index

  Neck pain and disability

  3 month after accident

• Neck disability index

  Neck disability index

  6 month after accident

• Neck disability index

  Neck disability index

  12 month after accident

Secondary Outcomes (62)

• Heart Rrate Variability, respiration frequency, resting heart rate and sleep

  <72 hours after accident

• Heart Rrate Variability, respiration frequency, resting heart rate and sleep

  3 moths after accident

• Heart Rrate Variability, respiration frequency, resting heart rate and sleep

  6 moths after accident

• Heart Rrate Variability, respiration frequency, resting heart rate and sleep

  12 moths after accident

• Neck mobility

  < 72 hours after accident

Other Outcomes (3)

• DREAM

  24 month after accident

• The National Patient Register

  24 month after accident

• The Register of Pharmaceutical Sales

  24 month after accident

Study Arms (1)

Post traumatic neck pain (i.e. whiplash)

To be considered eligible for inclusion participants must meet the following criteria: Inclusion criteria: 18-60 years of age, post-traumatic neck pain of a musculoskeletal nature without fractures or slippage of vertebrae acquired within the last 72 hours in connection an accident. Participants must be able to read and speak Danish. Exclusion criteria: Previous pain discomfort after similar accidents, existing chronic back pain at the time of the accident, diagnosed with concussion after the accident, suspected or known spinal pathology, including confirmed fracture or slippage of vertebrae at the time of the accident, previous back or neck surgery, spinal cord injuries, severe psychiatric history (e.g., schizophrenia and depression), trauma patients or existing rheumatological or neurological disorders.

Diagnostic Test: screening tool with biomarkers for prediction of chronic post traumatic neck pain

Interventions

screening tool with biomarkers for prediction of chronic post traumatic neck pain DIAGNOSTIC_TEST

Diagnostic screening with biomarkers for prediction of chronic post traumatic neck pain

Post traumatic neck pain (i.e. whiplash)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants presenting with neck pain after an accident

You may qualify if:

• years of age
• post-traumatic neck pain of a musculoskeletal nature without fractures or slippage of vertebrae acquired within the last 72 hours after accident.
• Participants must be able to read and speak Danish

You may not qualify if:

• Existing chronic pain at the time of the accident
• Suspected or known spinal pathology, including confirmed fracture or slippage of vertebrae at the time of the accident
• Previous back or neck surgery
• Spinal cord injuries
• Severe psychiatric history (e.g., schizophrenia and depression)
• Existing rheumatological or neurological disorders

Sponsors & Collaborators

• University of Southern Denmark: lead
• Specialized Hospital for Polio and Accident Victims, Rødovre, Denmark: collaborator
• Næstved-Slagelse-Ringsted Hospital Research Fund: collaborator
• The Danish Victims Fund: collaborator
• The Research and Implementation Unit PROgrez, Region Zealand,Denmark: collaborator

Related Publications (1)

• Lynaes C, Ravn SL, Skou ST, Mogensen CB, Arvig MD, Christensen SWM, Sterling M, Andersen TE. Long-term recovery from post-traumatic neck pain: protocol for a prospective cohort study in the emergency department. BMJ Open. 2025 Nov 21;15(11):e099236. doi: 10.1136/bmjopen-2025-099236.

  PMID: 41271421 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Hair Samples for analysis of cortisol prior to accident (i.e three month)

MeSH Terms

Conditions

Whiplash Injuries; Neck Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Christian Lynæs, MSC

CONTACT

004521685092; clynaes@health.sdu.dk

Tonny Andersen, Ph.D.

CONTACT

004520612003; tandersen@health.sdu.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT MSc

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: December 19, 2023
• Study Start: April 1, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share