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

Study Overview

• Status: Completed
• Conditions: Neck Pain; Neck Disorders

• Study Type: Observational
• Enrollment (Actual): 350

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients suffering from neck pain

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Neck pain patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anamnestic criteria_administrative data (descriptive)	i.e. name of the patient, date of birth, sex, BMI, profession, hobbies	1 single time at first intake
anamnestic criteria_ red flag screening (descriptive)	i.e. a list of signs and symptoms that could refer to a severe underlying pathology	1 single time at first intake
anamnestic criteria_ body chart (descriptive)	i.e. a body map where pain localization, referred pain areas and the quality of the pain are registered	1 single time at first intake
anamnestic criteria_ movement restriction(s) (descriptive)	i.e. all movements that are limited due to the patients neck complaints are registered	1 single time at first intake
anamnestic criteria_ onset and evolution of the neck complaints (descriptive)	i.e. the onset and the evolution of the neck complaints are registered	1 single time at first intake
anamnestic criteria_ better/worse section (descriptive)	i.e. all activities that provoke and/or reduce the neck complaints are listed	1 single time at first intake
anamnestic criteria_ history (descriptive)	i.e. the previous episodes of similar complaints are registered	1 single time at first intake
anamnestic criteria_ previous treatment (descriptive)	i.e. previous treatments for similar complaints are recorded	1 single time at first intake
anamnestic criteria_ yellow flags (descriptive)	i.e. beliefs and appraisals of the patient which may lead to chronic neck pain are registered	1 single time at first intake
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	1 single time at first intake
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	1 single time at first intake
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	1 single time at first intake
clinical examination criteria_ additional testing for articular involvement (descriptive)	i.e. passive intervertebral provocation and movement testing of the spinal segments of the neck	1 single time at first intake
clinical examination criteria_ additional testing for myofascial involvement (descriptive)	i.e. assessment of the muscle length, strength, pain provocation in tender points	1 single time at first intake
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	1 single time at first intake
clinical examination criteria_ additional testing for central involvement (descriptive)	i.e. the NDI and CSI questionnaire	1 single time at first intake
clinical examination criteria_ sensory motor control involvement (descriptive)	i.e. examination of the neuromuscular control of the cervical flexor and extensor muscles	1 single time at first intake
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	1 single time at first intake
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	1 single time at first intake
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	1 single time at first intake
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	1 single time at first intake

Collaborators and Investigators

• Sponsor: University Ghent

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: September 22, 2016
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Diagnostics, clinical criteria, clincal reasoning, neck pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 2015/0971

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No