Clinical trial NCT05468684: PROCO Neck: The Course and Neuroplasticity in Neck Pain-Associated Disorders and Whiplash-Associated Disorders
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neck Pain
Whiplash
Pain, Acute
Psychosocial Functioning
Activity, Motor
Alteration of Cognitive Function
Pain, Chronic
Pain Catastrophizing
Overactivity; Behavior
Lead sponsor: University of applied sciences
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2022-07-21
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with acute NAD or acute WAD, 18-65 years old with the ability to read, write, and understand German.

Brief summary: 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.

Detailed description: 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:

The proposed study design is an observational longitudinal cohort study investigating functional, clinical, and psychosocial factors in NAD and WAD patients over one year. The study protocol comprises four-measurement points at 1-3-6-12 months after the onset of pain.

Recruitment process:

In a simple random sampling, patients will be recruited from local physiotherapists and general practitioners (GP) when presenting with NAD and WAD. Furthermore, information flyers and posters will be distributed in various medical associations (hospitals, massage practice). Then, we will use e-mail distribution within affiliates of the University of Zurich and the ZHAW. Finally, we will call on different social media channels like Facebook and Twitter.

Psychometric instruments We will collect demographic and questionnaire data using the online survey tool REDCap (Research Electronic Data Capture, https://projectredcap.org/software/), widely used in the academic research community for flexible and robust data collection. The application of online surveys reduces costs and time, including automated checks for plausibility and completeness. Participants are more diverse demographically than the paper-and-pencil method, and both ways revealed similar results.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain intensity
timeFrame: 1 year
measure: Disability
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Zurich University of Applied Sciences: School of Health Sciences
state: Zurich
Study officials:
affiliation: University of applied sciences
name: Sabina Hotz-Boendermaker
role: PRINCIPAL_INVESTIGATOR
References: