Neck PainNCT05468684
PROCO Neck: The Course and Neuroplasticity in Neck Pain-Associated Disorders and Whiplash-Associated Disorders
An observational study of Neck Pain and Whiplash, run by University of applied sciences at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Whiplash, Pain, Acute
- How many people
- 168 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2022to 31 May 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Subjects with acute NAD or acute WAD, 18-65 years old with the ability to read, write, and understand German.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Zurich University of Applied Sciences: School of Health Sciences
Winterthur, Canton of Zurich, 8400
Rita Morf, +41589346039, moff@zhaw.ch
Sabina Hotz-Boendermaker, +41589346301, sabina.hotzboendermaker@zhaw.ch
About this study
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
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:
Read more
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.
Read the 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:
- 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.
- Conditions
- Neck Pain, Whiplash, Pain, Acute, Psychosocial Functioning, Activity, Motor, Alteration of Cognitive Function
- Being tested
- no intervention
- Medical subject headings
- Neck Pain, Whiplash Injuries, Acute Pain, Motor Activity, Chronic Pain, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Neck Pain-Associated Disorders | neck pain without an acceleration-deceleration mechanism Receives: 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 Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of applied sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Sabina Hotz-Boendermaker, Principal investigator, University of applied sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468684
- Sponsor's protocol ID
- 32003B_205101/1
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Morf R, Reicherzer L, Degenfellner J, Hotz-Boendermaker S. Activity Patterns and Stress-Prognostic Factors for Pain Persistence and Disability in Acute Neck Pain: A 1-Year Prospective Cohort Study. Eur J Pain. 2026 Jul;30(6):e70303. doi: 10.1002/ejp.70303.
PubMed 42175688Morf 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.
PubMed 41322119
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05468684
- Acronym / sponsor ID
- 32003B_205101/1
- Conditions
- Neck Pain, Whiplash, Pain, Acute, Psychosocial Functioning, Activity, Motor, Alteration of Cognitive Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- University of applied sciencesUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neck Pain-Associated Disorders | – | Other: no interventionneck pain without an acceleration-deceleration mechanism |
| Whiplash-Associated Disorders | – | Other: no interventionneck pain resulting from a traumatic acceleration-deceleration mechanism and classified as WAD Grade I-III on the modified Quebec Task Force Scale |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects with acute NAD or acute WAD, 18-65 years old with the ability to read, write, and understand German.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionthere 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. | Other | Neck Pain-Associated Disorders, Whiplash-Associated Disorders |
Primary outcome
Pain intensity
Time frame: 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".
Disability
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Derived from this study: PubMed 42175688Morf R, Reicherzer L, Degenfellner J, Hotz-Boendermaker S. Activity Patterns and Stress-Prognostic Factors for Pain Persistence and Disability in Acute Neck Pain: A 1-Year Prospective Cohort Study. Eur J Pain. 2026 Jul;30(6):e70303. doi: 10.1002/ejp.70303.
- Derived from this study: PubMed 41322119Morf 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabina Hotz-Boendermaker principal investigator
University of applied sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Whiplash, run by University of applied sciences at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rita Morf, MSc (+41 58 934 60 39, moff@zhaw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05468684, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.