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

Neck Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147508
• Other study ID #: 2015/0971
• Status: Completed
• Start date: September 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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, 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Disorders
• Neck Pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anamnestic criteria_administrative data (descriptive)	i.e. name of the patient, date of birth, sex, BMI, profession, hobbies	1 single time at first intake
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	anamnestic criteria_ history (descriptive)	i.e. the previous episodes of similar complaints are registered	1 single time at first intake
Primary	anamnestic criteria_ previous treatment (descriptive)	i.e. previous treatments for similar complaints are recorded	1 single time at first intake
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	clinical examination criteria_ additional testing for central involvement (descriptive)	i.e. the NDI and CSI questionnaire	1 single time at first intake
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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