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

NCT05468684 | Not Yet Recruiting

• 1 other identifier: 32003B_205101/1
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Neck Pain-Associated Disorders

neck pain without an acceleration-deceleration mechanism

Other: no intervention

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

Interventions

no intervention OTHER

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.

Neck Pain-Associated Disorders; Whiplash-Associated Disorders

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of applied sciences: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Zurich University of Applied Sciences: School of Health Sciences

Winterthur, Canton of Zurich, 8400, Switzerland

Location

Related Publications (1)

• Morf R, Kernwein C, Jaeger J, Reicherzer L, Degenfellner J, Hotz-Boendermaker S. Prognostic value of activity patterns and stress measures for persistent pain and disability in acute neck pain: a 3-month follow-up study. Front Pain Res (Lausanne). 2025 Nov 13;6:1686389. doi: 10.3389/fpain.2025.1686389. eCollection 2025.

  PMID: 41322119 DERIVED

MeSH Terms

Conditions

Neck Pain; Whiplash Injuries; Acute Pain; Motor Activity; Chronic Pain; Spasm

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neck Injuries; Wounds and Injuries; Behavior; Neuromuscular Manifestations; Nervous System Diseases

Study Officials

• Sabina Hotz-Boendermaker

  University of applied sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Morf, MSc

CONTACT

+41 58 934 60 39; moff@zhaw.ch

Sabina Hotz-Boendermaker

CONTACT

+41 58 934 63 01; sabina.hotzboendermaker@zhaw.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 21, 2022
• Study Start: September 1, 2022
• Primary Completion: May 31, 2024
• Study Completion (Estimated): May 31, 2026
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

CH (1)