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

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05468684
• Other study ID #: 32003B_205101/1
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: July 2022
• Source: University of applied sciences
• Contact: Rita Morf, MSc
• Phone: +41 58 934 60 39
• Email: moff[@]zhaw.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2024
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Activity, Motor
• Acute Pain
• Alteration of Cognitive Function
• Chronic Pain
• Hyperkinesis
• Neck Pain
• Overactivity; Behavior
• Pain Catastrophizing
• Pain, Acute
• Pain, Chronic
• Psychosocial Functioning
• Whiplash
• Whiplash Injuries

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Zurich University of Applied Sciences: School of Health Sciences	Winterthur	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of applied sciences	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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