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

Unknown statusNCT06176209
View the official record on ClinicalTrials.gov

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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 (…

Study details

Official title
Validating a Brief Screening Tool With Biomarkers for Prediction of Chronic Post Traumatic Neck Pain: A Prospective Cohort Study
Conditions
  • Neck Pain Following Traffic Accident
Interventions
  • Diagnostic test: screening tool with biomarkers for prediction of chronic post traumatic neck pain
Sponsor
University of Southern Denmark
Collaborators
Specialized Hospital for Polio and Accident Victims, Rødovre, Denmark; Næstved-Slagelse-Ringsted Hospital Research Fund; The Danish Victims Fund; The Research and Implementation Unit PROgrez, Region Zealand,Denmark
Start date
2024-04-01
Primary completion
2025-01-01
Sex
All
Age range
from 18 Years to 60 Years
Results posted
No results posted in this snapshot
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 after accident. * Participants must be able to read and speak Danish Exclusion Criteria: * 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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06176209