Clinical trial NCT03147508: Investigating Clinical Indicators of Spine Related Dysfunction Patterns. A Clinical Study on Neck Pain Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain
Neck Disorders
Keywords: Diagnostics, clinical criteria, clincal reasoning, neck pain
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from neck pain

Brief 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, 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


Eligibility criteria: 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

Primary outcomes:
measure: Anamnestic criteria_administrative data (descriptive)
timeFrame: 1 single time at first intake
measure: anamnestic criteria_ red flag screening (descriptive)
timeFrame: 1 single time at first intake
measure: anamnestic criteria_ body chart (descriptive)
timeFrame: 1 single time at first intake
measure: anamnestic criteria_ movement restriction(s) (descriptive)
timeFrame: 1 single time at first intake
measure: anamnestic criteria_ onset and evolution of the neck complaints (descriptive)
timeFrame: 1 single time at first intake
measure: anamnestic criteria_ better/worse section (descriptive)
timeFrame: 1 single time at first intake
measure: anamnestic criteria_ history (descriptive)
timeFrame: 1 single time at first intake
measure: anamnestic criteria_ previous treatment (descriptive)
timeFrame: 1 single time at first intake
measure: anamnestic criteria_ yellow flags (descriptive)
timeFrame: 1 single time at first intake
measure: anamnestic criteria_ results of additional (technical) investigations (descriptive)
timeFrame: 1 single time at first intake
measure: clinical examination criteria_ inspection & palpation (descriptive)
timeFrame: 1 single time at first intake
measure: clinical examination criteria_ basic functional assessment of the neck and shoulder (descriptive)
timeFrame: 1 single time at first intake
measure: clinical examination criteria_ additional testing for articular involvement (descriptive)
timeFrame: 1 single time at first intake
measure: clinical examination criteria_ additional testing for myofascial involvement (descriptive)
timeFrame: 1 single time at first intake
measure: clinical examination criteria_ additional testing for neurological involvement (descriptive)
timeFrame: 1 single time at first intake
measure: clinical examination criteria_ additional testing for central involvement (descriptive)
timeFrame: 1 single time at first intake
measure: clinical examination criteria_ sensory motor control involvement (descriptive)
timeFrame: 1 single time at first intake
measure: clinical examination criteria_ additional testing for other areas related to the patient's neck complaints (descriptive)
timeFrame: 1 single time at first intake
measure: Clinical reasoning variables_ tissue mechanisms (descriptive)
timeFrame: 1 single time at first intake
measure: Clinical reasoning variables_ pain mechanisms (descriptive)
timeFrame: 1 single time at first intake
measure: Clinical reasoning variables_ dominant dysfunction pattern (descriptive)
timeFrame: 1 single time at first intake
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.