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Neck PainNCT03147508

Investigating Clinical Indicators of Spine Related Dysfunction Patterns. A Clinical Study on Neck Pain Patients.

An observational study of Neck Pain and Neck Disorders, run by University Ghent.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of is this study is to investigate the reliability and validity of a classification system for neck pain patients. In a previous study clinical experts were asked about the clinical criteria they considered to be determinative for 5 predefined dysfunction patterns in patients with neck problems: 1) articular… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neck Pain, Neck Disorders
How many people
350 participants
Where
No sites listed yet
Study dates
Sep 2016to 31 Dec 2020
How long will I take part?
1 Week
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients suffering from neck pain

Who may be able to join

  • Patients suffering from neck pain

Who cannot join

  • Known serious underlying pathology (RED FLAGS):
  • cancer, metastatsis, untreated fractures, history of diabetes or pathology of the central nervous system, non-musculoskeletal neck pain

About this study

The goal of is this study is to investigate the reliability and validity of a classification system for neck pain patients. In a previous study clinical experts were asked about the clinical criteria they considered to be determinative for 5 predefined dysfunction patterns in patients with neck problems: 1) articular, 2) myofascial, 3) neural, 4) central, and 5) sensorimotor control dysfunction pattern. This Delphi survey revealed a list of pertinent anamnestic and clinical criteria per dysfunction pattern.

In the present study we will collect anamnestic and clinical data of 200 neck pain patients. This will be obtained by approximately 20 clinicians that fill out a standardized registration form at the intake of their patients with neck pain.

Read more

The therapists and patients will receive an informed consent that clarifies the purpose of the study and what happens next with the collected data.

Per patient the therapist indicates the dominant clinical pattern based on his/her experience. Prior to the data analysis, the researchers will be blinded to the patient identification data. Subsequent, the registration forms will be screened for the presence of clinical criteria (obtained from previous Delphi study), independent of the therapist's diagnosis/conclusions. A second independent researcher will gather this information, which will be used for statistical analysis, in order to investigate which clinical criteria can be considered as determinative for a particular pattern. Outcome measures for these analysis are:

  • sensitivity and classification specificity
  • (positive and negative) likelihood ratios
  • odds ratios
  • diagnostic accuracy
Keywords
Diagnostics, clinical criteria, clincal reasoning, neck pain
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03147508
Study groupRoleWhat they receive
Neck pain patientsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anamnestic criteria_administrative data (descriptive)

    i.e. name of the patient, date of birth, sex, BMI, profession, hobbies

    Measured: 1 single time at first intake

  2. anamnestic criteria_ red flag screening (descriptive)

    i.e. a list of signs and symptoms that could refer to a severe underlying pathology

    Measured: 1 single time at first intake

  3. anamnestic criteria_ body chart (descriptive)

    i.e. a body map where pain localization, referred pain areas and the quality of the pain are registered

    Measured: 1 single time at first intake

  4. anamnestic criteria_ movement restriction(s) (descriptive)

    i.e. all movements that are limited due to the patients neck complaints are registered

    Measured: 1 single time at first intake

  5. anamnestic criteria_ onset and evolution of the neck complaints (descriptive)

    i.e. the onset and the evolution of the neck complaints are registered

    Measured: 1 single time at first intake

  6. anamnestic criteria_ better/worse section (descriptive)

    i.e. all activities that provoke and/or reduce the neck complaints are listed

    Measured: 1 single time at first intake

  7. anamnestic criteria_ history (descriptive)

    i.e. the previous episodes of similar complaints are registered

    Measured: 1 single time at first intake

  8. anamnestic criteria_ previous treatment (descriptive)

    i.e. previous treatments for similar complaints are recorded

    Measured: 1 single time at first intake

  9. anamnestic criteria_ yellow flags (descriptive)

    i.e. beliefs and appraisals of the patient which may lead to chronic neck pain are registered

    Measured: 1 single time at first intake

  10. anamnestic criteria_ results of additional (technical) investigations (descriptive)

    i.e. results of medical imagery, EMG testing, blood test that are available to the patient are collected

    Measured: 1 single time at first intake

  11. clinical examination criteria_ inspection & palpation (descriptive)

    i.e. inspection of the overall posture of the head and neck, and palpation of the soft tissues in that area to appreciate the muscle tone, temperature, swelling

    Measured: 1 single time at first intake

  12. clinical examination criteria_ basic functional assessment of the neck and shoulder (descriptive)

    i.e. active and passive movement examination of the neck and shoulder to assess the range of motion, pain, and quality of movement

    Measured: 1 single time at first intake

  13. clinical examination criteria_ additional testing for articular involvement (descriptive)

    i.e. passive intervertebral provocation and movement testing of the spinal segments of the neck

    Measured: 1 single time at first intake

  14. clinical examination criteria_ additional testing for myofascial involvement (descriptive)

    i.e. assessment of the muscle length, strength, pain provocation in tender points

    Measured: 1 single time at first intake

  15. clinical examination criteria_ additional testing for neurological involvement (descriptive)

    i.e. neurodynamic testing: palpation of the peripheral nerves in the upper limb, upper limb tension tests, reflex testing, motor and sensory function

    Measured: 1 single time at first intake

  16. clinical examination criteria_ additional testing for central involvement (descriptive)

    i.e. the NDI and CSI questionnaire

    Measured: 1 single time at first intake

  17. clinical examination criteria_ sensory motor control involvement (descriptive)

    i.e. examination of the neuromuscular control of the cervical flexor and extensor muscles

    Measured: 1 single time at first intake

  18. clinical examination criteria_ additional testing for other areas related to the patient's neck complaints (descriptive)

    i.e. temporomandibular joint / thoracic spine / lumbar spine / lower limb / abdominal examination

    Measured: 1 single time at first intake

  19. Clinical reasoning variables_ tissue mechanisms (descriptive)

    i.e. the interpretation of the therapist on the dominant tissue mechanism (nociceptive - mechanical - neuropathic - central pain) is registered

    Measured: 1 single time at first intake

  20. Clinical reasoning variables_ pain mechanisms (descriptive)

    i.e. the interpretation of the therapist on the dominant pain mechanism (input-processing-output) for that particular patient is registered, as described in a study by Gifford et al., 1998; Butler, 2000

    Measured: 1 single time at first intake

  21. Clinical reasoning variables_ dominant dysfunction pattern (descriptive)

    i.e. the presence of a cluster of findings that raise suspicion of a dominant dysfunction pattern as described in a previous study by Dewitte et al., 2016

    Measured: 1 single time at first intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2017
  2. Study startSep 2016
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

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
Cross-sectional
Enrolment
350 participants (actual)
Target duration
1 Week
IDs, dates and publications
ClinicalTrials.gov ID
NCT03147508
Sponsor's protocol ID
2015/0971
Status last verified
Nov 2021
First submitted
22 Sep 2016
Last updated
1 Dec 2021
Results posted
No
Individual data sharing
No

Publications

  • Dewitte V, Peersman W, Danneels L, Bouche K, Roets A, Cagnie B. Subjective and clinical assessment criteria suggestive for five clinical patterns discernible in nonspecific neck pain patients. A Delphi-survey of clinical experts. Man Ther. 2016 Dec;26:87-96. doi: 10.1016/j.math.2016.07.005. Epub 2016 Jul 21.

    PubMed 27507590

  • Dewitte V, De Pauw R, Danneels L, Bouche K, Roets A, Cagnie B. The interrater reliability of a pain mechanisms-based classification for patients with nonspecific neck pain. Braz J Phys Ther. 2019 Sep-Oct;23(5):437-447. doi: 10.1016/j.bjpt.2018.10.008. Epub 2018 Oct 29.

    PubMed 30389348

Questions about this trial

What is this clinical trial studying?

An observational study of Neck Pain and Neck Disorders, run by University Ghent.

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 1 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: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anamnestic criteria_administrative data (descriptive) (time frame: 1 single time at first intake). The study lists 21 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 NCT03147508, 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 1 Dec 2021.

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