Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion

Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion - Prospective, Observational Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06601634

Enrollment

Registered

2024-09-19

Start date

2024-11-17

Completion date

2027-12-31

Last updated

2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Disc Disease, Cervical Spondylosis, Neck Pain

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Predictors of functional outcomes following ACDF.	On the day of discharge from the hospital, at 6 months, 1 year, 2 years	Change in NDI ( neck disability index), with calculated MCID as 7.5
Predictors of the reduction of axial neck pain following ACDF.	On the day of discharge from the hospital, at 6 months, 1 year, 2 years	Change in VAS neck pain ( visual analog scale), with calculated MCID ( Minimal Clinically Important Difference) as 2.5

Secondary

Measure	Time frame	Description
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	Change in VAS neck pain ( visual analog scale), with calculated MCID ( Minimal Clinically Important Difference) as 2.5 in population with predominant neck pain. (VAS neck - VAS arm ≥ 1.0 point)
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	Change in NDI ( neck disability index), with calculated MCID as 7.5 in population with predominant neck pain. (VAS neck - VAS arm ≥ 1.0 point)

Countries

Poland

Contacts

Primary ContactJan Chrzanowski, MD

jan.chrzanowski@uckwum.pl+48510742795

Outcome results