PROCO Neck: The Course and Neuroplasticity in Neck Pain-Associated Disorders and Whiplash-Associated Disorders

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neck Pain; Pain, Acute; Pain, Chronic; Pain Catastrophizing; Whiplash; Psychosocial Functioning; Alteration of Cognitive Function; Activity, Motor; Overactivity; Behavior
• Intervention / Treatment: Other: no intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 168

Contacts and Locations

• Study Contact: Name: Rita Morf, MSc; Phone Number: +41 58 934 60 39; Email: moff@zhaw.ch
• Study Contact Backup: Name: Sabina Hotz-Boendermaker; Phone Number: +41 58 934 63 01; Email: sabina.hotzboendermaker@zhaw.ch

Study Locations

• Switzerland
  • Zurich
    • Winterthur, Zurich, Switzerland, 8400
      • Zurich University of Applied Sciences: School of Health Sciences
      • Contact: Rita Morf; Phone Number: +41589346039; Email: moff@zhaw.ch
      • Contact: Sabina Hotz-Boendermaker; Phone Number: +41589346301; Email: sabina.hotzboendermaker@zhaw.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neck Pain-Associated Disorders; neck pain without an acceleration-deceleration mechanism	Other: no intervention; there are no interventions planned, we observe the patients in a cohort study which is named inception cohort study because we test participants before the condition develops.
Whiplash-Associated Disorders; neck pain resulting from a traumatic acceleration-deceleration mechanism and classified as WAD Grade I-III on the modified Quebec Task Force Scale	Other: no intervention; there are no interventions planned, we observe the patients in a cohort study which is named inception cohort study because we test participants before the condition develops.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	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".	1 year
Disability	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)	1 year

Collaborators and Investigators

• Sponsor: University of applied sciences
• Collaborators: Swiss National Science Foundation
• Investigators: Principal Investigator: Sabina Hotz-Boendermaker, University of applied sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): May 31, 2026

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Dyskinesias; Neck Injuries; Chronic Pain; Neck Pain; Acute Pain; Whiplash Injuries; Hyperkinesis
• Other Study ID Numbers: 32003B_205101/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No