Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMedical University of Warsaw
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to provide informed consent
Patients who are qualified for one- or two-level ACDF for the treatment of degenerative cervical pathology
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
On the day of discharge from the hospital, at 6 months, 1 year, 2 years2
Predictors of functional outcomes following ACDF.
Change in NDI ( neck disability index), with calculated MCID as 7.5
Time frame
On the day of discharge from the hospital, at 6 months, 1 year, 2 yearsSecondary outcomes
1
Predictors of the reduction of axial neck pain following ACDF in population with predominant neck pain.
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)
Time frame
On the day of discharge from the hospital, at 6 months, 1 year, 2 years2
Predictors of functional outcomes following ACDF in population with predominant neck pain.
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)
Time frame
On the day of discharge from the hospital, at 6 months, 1 year, 2 yearsSponsors and contacts
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Source ClinicalTrials.gov