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Completed

NCT Number: NCT03147508

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

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.

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

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Key information

Conditions

Neck Pain Neck Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients suffering from neck pain

Exclusion criteria

Known serious underlying pathology (RED FLAGS):

cancer, metastatsis, untreated fractures, history of diabetes or pathology of the central nervous system, non-musculoskeletal neck pain

Treatment and study plan

Primary outcomes

  1. Anamnestic criteria_administrative data (descriptive)

    Time frame: 1 single time at first intake

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

  2. anamnestic criteria_ red flag screening (descriptive)

    Time frame: 1 single time at first intake

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

  3. anamnestic criteria_ body chart (descriptive)

    Time frame: 1 single time at first intake

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

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

    Time frame: 1 single time at first intake

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

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

    Time frame: 1 single time at first intake

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

  6. anamnestic criteria_ better/worse section (descriptive)

    Time frame: 1 single time at first intake

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

  7. anamnestic criteria_ history (descriptive)

    Time frame: 1 single time at first intake

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

  8. anamnestic criteria_ previous treatment (descriptive)

    Time frame: 1 single time at first intake

    i.e. previous treatments for similar complaints are recorded

  9. anamnestic criteria_ yellow flags (descriptive)

    Time frame: 1 single time at first intake

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

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

    Time frame: 1 single time at first intake

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

  11. clinical examination criteria_ inspection & palpation (descriptive)

    Time frame: 1 single time at first intake

    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

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

    Time frame: 1 single time at first intake

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

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

    Time frame: 1 single time at first intake

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

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

    Time frame: 1 single time at first intake

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

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

    Time frame: 1 single time at first intake

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

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

    Time frame: 1 single time at first intake

    i.e. the NDI and CSI questionnaire

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

    Time frame: 1 single time at first intake

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

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

    Time frame: 1 single time at first intake

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

  19. Clinical reasoning variables_ tissue mechanisms (descriptive)

    Time frame: 1 single time at first intake

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

  20. Clinical reasoning variables_ pain mechanisms (descriptive)

    Time frame: 1 single time at first intake

    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

  21. Clinical reasoning variables_ dominant dysfunction pattern (descriptive)

    Time frame: 1 single time at first intake

    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

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 10, 2017
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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