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

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. 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. 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. 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. 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.

Following inclusion participants will undergo evaluation of:

Hart rate variability using Fristbeat Bodyguard II, neurologic screening, Cervical range of motion screening.

At followup (1- and 3-months) participants will undergo evaluation of. Evaluation of cervical range of motion, Quantitative sensory testing (pressure pain threshold, cold pressor test followed by pressure pain threshold.

Questionnaires: Acute self-reported stress (NRS), Expected improvement (0-100%), Pain (Short Form -McGill pain questionnaire) Neck disability index, Stress, anxiety and depression, post-traumatic stress disorder, Pain catastrophizing, Quality of life, Global rating of change, Self-reported sleep, Comorbidity, Physical Activity.

At 6- and 12- month: Evaluation of heart rate variability and the questionnaires from 1- week and 3 months will be repeated.

Conditions

• Neck Pain Following Traffic Accident

Interventions

DIAGNOSTIC_TEST

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

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

Sponsors & Collaborators

• Specialized Hospital for Polio and Accident Victims, Rødovre, Denmark

  collaborator UNKNOWN

• Næstved-Slagelse-Ringsted Hospital Research Fund

  collaborator UNKNOWN

• The Danish Victims Fund

  collaborator OTHER_GOV

• The Research and Implementation Unit PROgrez, Region Zealand,Denmark

  collaborator UNKNOWN

• University of Southern Denmark

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-01

Primary Completion

2025-01-01

Completion

2026-06-30