Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion - Prospective, Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Predictors of the reduction of axial neck pain following ACDF.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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
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
- 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)
Investigators
Jan Chrzanowski
MD
Medical University of Warsaw