Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion

NCT ID: NCT06601634

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-17

Study Completion Date

2027-12-31

Brief Summary

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Neck pain is a common, multifactorial condition. In the case of degenerative cervical spinal disease, it can result from changes in the intervertebral discs, muscles, intervertebral joints, or sagittal imbalance. Anterior cervical discectomy and fusion (ACDF) is a currently widely accepted procedure for treating cervical degenerative spine disease, with a high patient satisfaction rate. In the current state of knowledge, it is not used for treating axial neck pain, but rather in cases of discopathy causing spinal myelopathy or cervical radiculopathy, in which neck pain often coexists or predominates. The current literature provides ample evidence of the significant effect of ACDF in improving axial neck pain in the conditions mentioned previously. However, little information exists on which patients achieve improvement. The aim of this prospective study is to analyze the outcomes of ACDF in patients with neck pain and to identify predictors of reduction in axial neck pain after ACDF.

Detailed Description

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Conditions

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Neck Pain Cervical Spondylosis Cervical Disc Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Ability to provide informed consent
* Patients who are qualified for one- or two-level ACDF for the treatment of degenerative cervical pathology

Exclusion Criteria

* Previous cervical spine surgery
* Previous cervical spine trauma
* Other diseases causing neck pain include rheumatoid arthritis, lupus, polymyalgia rheumatica, myositis, seronegative inflammatory diseases, and fibromyalgia
* Drug abuse
* Myelopathy
* Spinal infection
* VAS neck pain score less than 3 (Inability to achieve an MCID which is calculated as 2.5 for the VAS scale)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Jan Chrzanowski

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Orthopaedics, J. Dietl Specialist Hospital

Krakow, Lesser Poland Voivodeship, Poland

Site Status RECRUITING

Department of Neurosurgery, Medical University of Warsaw

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Jan Chrzanowski, MD

Role: CONTACT

+48510742795

Facility Contacts

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Jan Chrzanowski, MD

Role: primary

+48510742795

Jan Chrzanowski, MD

Role: primary

+48510742795

Other Identifiers

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WUMStudy

Identifier Type: -

Identifier Source: org_study_id

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