Identifying factors that improve neck pain after cervical spine surgery
Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion - Prospective, Observational Study
This study looks at what factors can help people with neck pain feel better after having surgery to fix their cervical spine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 2 sites (Krakow, Lesser Poland Voivodeship and 1 other locations) |
| Trial ID | NCT06601634 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the outcomes of anterior cervical discectomy and fusion (ACDF) in patients suffering from neck pain due to degenerative cervical conditions. It seeks to identify predictors that may indicate which patients are likely to experience significant improvement in their axial neck pain following the procedure. By focusing on a specific patient population eligible for ACDF, the study will gather data on pain reduction and other relevant outcomes. The findings could enhance understanding of patient selection for ACDF in the context of neck pain management.
Who should consider this trial
Good fit: Ideal candidates for this study are patients eligible for one- or two-level ACDF due to degenerative cervical pathology.
Not a fit: Patients with previous cervical spine surgery, trauma, or other specific diseases causing neck pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify which patients are most likely to benefit from ACDF, leading to improved treatment strategies for neck pain.
How similar studies have performed: While there is existing literature on ACDF's effectiveness for neck pain, this study's focus on identifying specific predictors of improvement is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Krakow, Lesser Poland Voivodeship and 1 other locations
- Department of Orthopaedics, J. Dietl Specialist Hospital — Krakow, Lesser Poland Voivodeship, Poland (Recruiting)
- Department of Neurosurgery, Medical University of Warsaw — Warsaw, Masovian Voivodeship, Poland (Recruiting)
Study contacts
- Study coordinator: Jan Chrzanowski, MD
- Email: jan.chrzanowski@uckwum.pl
- Phone: +48510742795
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.