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NCT Number: NCT06601634

Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopaedics, J. Dietl Specialist Hospital, Krakow, Lesser Poland Voivodeship, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

    Time frame: 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

  2. Predictors of functional outcomes following ACDF.

    Time frame: 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

Secondary outcomes

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

    Time frame: 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)

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

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Chrzanowski, MD

CONTACT

[email protected]

+48510742795

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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