Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion

NCT06601634 | Recruiting

• 1 other identifier: WUMStudy
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Neck Pain; Cervical Spondylosis; Cervical Disc Disease

Outcome Measures

Primary Outcomes (2)

• Predictors of the reduction of axial neck pain following ACDF.

  Change in VAS neck pain ( visual analog scale), with calculated MCID ( Minimal Clinically Important Difference) as 2.5

  On the day of discharge from the hospital, at 6 months, 1 year, 2 years

• Predictors of functional outcomes following ACDF.

  Change in NDI ( neck disability index), with calculated MCID as 7.5

  On the day of discharge from the hospital, at 6 months, 1 year, 2 years

Secondary Outcomes (2)

• Predictors of the reduction of axial neck pain following ACDF in population with predominant neck pain.

  On the day of discharge from the hospital, at 6 months, 1 year, 2 years

• Predictors of functional outcomes following ACDF in population with predominant neck pain.

  On the day of discharge from the hospital, at 6 months, 1 year, 2 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We plan to prospectively enroll at least 60 patients who are qualified for one- or two-level ACDF for the treatment of degenerative cervical pathology with significant neck pain, and to identify predictors of the reduction in axial neck pain following surgery.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (2)

Department of Orthopaedics, J. Dietl Specialist Hospital

Krakow, Lesser Poland Voivodeship, 30-119, Poland

RECRUITING

Department of Neurosurgery, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

RECRUITING

MeSH Terms

Conditions

Neck Pain; Spondylosis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Jan Chrzanowski, MD

CONTACT

+48510742795; jan.chrzanowski@uckwum.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 19, 2024
• Study Start: November 17, 2024
• Primary Completion (Estimated): November 17, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

PL (2)