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

NCT ID: NCT03147508

Last Updated: 2021-12-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-12-31

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

Conditions

Neck Pain; Neck Disorders

Keywords

Diagnostics, clinical criteria, clincal reasoning, neck pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Neck pain patients

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: BACKGROUND

PMID: 27507590 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30389348 (View on PubMed)

Other Identifiers

2015/0971

Identifier Type: -

Identifier Source: org_study_id