The Course and Neuroplasticity in Neck Pain-Associated Disorders and Whiplash-Associated Disorders in the General Population: A One Year Prospective Observational Cohort Study PROCO-Neck
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Disability
研究概览
简要总结
Neck pain-associated disorders (NAD) and whiplash-associated disorders (WAD) are major health problems. NAD has a lifetime prevalence of 54%. Although the majority of patients recovers within the first three months, a minority develops persistent pain. WAD, in contrast, is reported less frequently, but patients are often suffering more badly. Patients with chronic symptoms represent a considerable burden in terms of pain, suffering, health care needs, and social costs. Findings on the natural course of NAD and WAD reflect the necessity to identify factors besides pain related to the persistence of symptoms. First, alterations of input and processing of multiple sensory modalities causing movement control impairment can result in persistent symptoms and affect the quality of life. Besides, findings of psychosocial factors predictive of pain outcomes support the growing body of research proposing a bidirectional relationship between somatic and psychosocial variables. In particular, there is a pressing need to investigate pain-related activity patterns, besides fear-avoidance behavior in NAD and WAD. Maladaptive activity pattern have an impact on on pain and disability in the long-term prognosis. Mt important, given the high prevalence of NAD and WAD, the cortical representation of the cervical spine has not yet been investigated and, reports on neuroplasticity remain scarce. These shortcomings should be addressed to provide evidence for the temporal aspect of neuroplasticity and its involvement in pain persistence.
Hypotheses:
We hypothesize I. that impaired sensorimotor abilities, mental health at baseline increase pain intensity and disability during measurement.
II. that maladaptive pain-related activity patterns avoidance and overactivity at baseline are prognostic factors for pain persistence and disability.
III. that the WAD cohort shows more depression, anxiety and stress compared to the NAD cohort.
详细描述
The proposed project comprises two parts. The prospective study will assess clinical and cognitive behavioral data at four time points (1-3-6-12 months) after the onset of pain. Part I investigates sensorimotor functioning and cognitive-behavioral variables in NAD and WAD, using state-of-the-art clinical assessments and questionnaires presented in an online survey. Part II explores for the first time the representation of the cervical spine in a control group and, subsequently investigates neuroplastic changes in sensorimotor networks. The association of clinical testing, questionnaire, and neuroimaging data may act as indicative factors for the development of persistent symptoms in NAD and WAD, respectively protective mechanisms in a remission of symptoms. We aim to gain insights into the time-related process of NAD and WAD - its similarities and differences - resulting from the changes in sensory processing, movement performance, and their interaction with cognitive-behavioral factors. The prospective approach might shed light on time dependent processes during the transition from acute to a persistent pain state. The proposed research is user-driven and has the potential to be translated into a target group-oriented assessment and treatment of NAD and WAD by a variety of health care professionals.
Primary Aims:
I. To observe functional, clinical, and psychosocial variables by using clinical tests and online surveys for 12 months in acute NAD and WAD cohorts in the working-age population.
II. To investigate the course and stability of pain-related activity patterns III. Compare functional, clinical, and psychosocial variables between NAD and WAD cohorts.
Experimental time points:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NAD cohort; neck pain without an acceleration-deceleration mechanism, inclusion < 1 month since onset of pain
- •WAD cohort; neck pain resulting from a traumatic acceleration-deceleration mechanism and classified as WAD Grade I-III on the modified Quebec Task Force Scale98, inclusion < 1 month since onset of pain
- •In recurrence, no pain in the previous three months
- •Age between 18 and 65 years at baseline
- •Ability to read, write, and understand German for completing the questionnaires.
排除标准
- •For both cohorts; a clinically relevant anatomical anomaly in the cervical spine (e.g., carcinoma), spine surgery; peripheral or central neurological illness, pregnancy, or women who gave birth in the last year (to avoid the confounding effects of pregnancy-related NAD)
- •For the WAD cohort, WAD Grade IV on the modified Quebec Task Force Scale (Fracture of dislocation), patients who lost consciousness due to the traumatic event and post-traumatic amnesia to exclude mild traumatic brain injury.
结局指标
主要结局
Disability
时间窗: 1 year
German version of the Neck Disability Index (NDI-G). The self-administered questionnaire consists of 10 items referring to various activities (personal care, lifting, driving, work, sleeping, concentration, reading, recreation) and pain (pain intensity, headache) with 6 possible answers per item. Each item is scored from 0 (no pain and no functional limitation) to 5 (worst pain and maximal limitation) points resulting in a minimal score of 0 points (no disability) to a maximum possible score of 50 points (totally disabled)
Pain intensity
时间窗: 1 year
Numeric Rating Scale (NRS). The NRS is a single 11- point numeric scale ranging from 0 to 10, with 0 representing "no pain" and 10 representing "worst pain you can imagine".
次要结局
未报告次要终点