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临床试验/NCT06176209
NCT06176209尚未招募不适用

Validating a Brief Screening Tool With Biomarkers for Prediction of Chronic Post Traumatic Neck Pain: A Prospective Cohort Study

University of Southern Denmark0 个研究点目标入组 155 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
155
主要终点
Neck disability index

研究概览

简要总结

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.

详细描述

Background Post-traumatic neck pain sustained after accidents are frequent (1) and represents a huge human and societal burden that can cause significant long-term pain and disability (2-4). It has been estimated that there are 6,000 new annual cases of traffic accidents resulting in post-traumatic neck pain in Denmark (5). However, recent international research indicates that the figure may be more than double (6-8). While up to half of those injured continue to experience symptoms a year after the accident (1-3), 15-25% experience significantly more severe symptoms and functional impairment (9,10) and are at risk of leaving the labour market. The accumulated cost of post traumatic neck pain in Denmark has not been evaluated in a scientific study but it is estimated the direct and indirect economic costs of post traumatic neck pain are approximately DKK 14 billion annually (11).

Post-traumatic neck pain after accident is often accompanied by a myriad of symptoms such as headaches, fatigue, concentration problems, and sensitivity to light and sound (4,12-16). A number of studies also point to frequent psychological symptoms after injuries such as symptoms of stress, depression, and anxiety (15-17), and early post-traumatic stress has been reported to predict poorer recovery over time (18,19).

Previous studies have identified the same risk factors after whiplash injuries (20-26). Risk factors are age, high pain intensity, hypersensitivity to pain, and post-traumatic arousal symptoms (i.e. increased stress) immediately after the accident. The results suggest that the lack of efficacy of existing treatments (27-30) :is caused by not specifically targeting risk patients and the underlying related mechanisms.

Ritchie and colleagues have developed and validated a clinical prognostic screening tool to identify patients at risk of developing post traumatic neck pain (31,32). The optimal use of the screening tool is immediately after accidents. Based on simple screening questions that can be answered in less than 5 minutes regarding pain and related functional limitations, post-traumatic stress disorder (hyperarousal) and age, the screening tool can with 90% accuracy be used to identify those that do not improve after the accident and with 80% accuracy those who recovers completely. However, there is a need to test the screening tool in a Danish context in the emergency department and investigate whether biomarkers for stress can improve the predictive value of the tool.

In Denmark, the standard emergency department treatment after non traumatic accident is a thorough physical evaluation coupled with good advice, which is appropriate for a significant proportion of patients. Unfortunately, it is difficult to distinguish a normal reaction from a treatment-requiring reaction, which in turn can lead to a worsening of traumatic neck pain. In this instance the prognostic tool (31,32) will be simple and quick to use. Collection of objective biomarkers for early stress response immediately after the accident will probably strengthen the value of the tool and provide more insight into causal mechanisms in the development of chronic post-traumatic neck pain. Moreover, biomarkers such as heart rate variability (HRV) can be collected immediately after an accident and thereby predict the risk of developing PTSD. Using questionnaires this information would take weeks to collect risking delayed identification of risk patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Neck disability index

时间窗: 12 month after accident

Neck disability index

次要结局

  • Physical Activity (GLA:D)(12 month after accident)
  • Heart Rrate Variability, respiration frequency, resting heart rate and sleep(12 moths after accident)
  • Neck rotation(1 week after accident)
  • Neck rotation (CROM)(3 month after accident)
  • Self-reported sleep (KSS)(12 month after accident)
  • Comorbidity (GLA:D)(12 month after accident)
  • Pain sensitivity (QST)(3 month after accident)
  • Pain (SF-MPQ)(12 month after accident)
  • Level of function (NDI)(12 month after accident)
  • neurological evaluation(3 month after accident)
  • PTSD (PDS, PCL-5)(12 month after accident)
  • Quality of life (EQ-5D-5L)(12 month after accident)
  • Neck mobility(< 72 hours after accident)
  • Patient Expected improvement (0-100%)(12 month after accident)
  • Stress, anxiety and depression (DASS-21)(12 month after accident)
  • Pain catastrophizing (PCS)(12 month after accident)
  • Acute self-reported stress (NRS)(12 month after accident)
  • Global rating of change (PGIC)(12 month accident)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christian Lynæs

PT MSc

University of Southern Denmark

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