Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Neck Pain, Cervical Spondylosis, Cervical Disc Disease. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion - Prospective, Observational Study
Overview
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.
Primary outcome measures
- 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]
- Predictors of functional outcomes following ACDF. [Time frame: On the day of discharge from the hospital, at 6 months, 1 year, 2 years]
Secondary outcome measures (2)
- 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]
- 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]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Poland · 2 centers
- Department of Orthopaedics, J. Dietl Specialist Hospital — Krakow
- Department of Neurosurgery, Medical University of Warsaw — Warsaw
Identifiers
NCT: NCT06601634 · WUMStudy