Clinical trial NCT06601634: Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion
Official title: Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion - Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neck Pain
Cervical Spondylosis
Cervical Disc Disease
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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.


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)

Primary outcomes:
measure: Predictors of the reduction of axial neck pain following ACDF.
timeFrame: On the day of discharge from the hospital, at 6 months, 1 year, 2 years
measure: Predictors of functional outcomes following ACDF.
timeFrame: On the day of discharge from the hospital, at 6 months, 1 year, 2 years
Secondary outcomes:
measure: Predictors of the reduction of axial neck pain following ACDF in population with predominant neck pain.
timeFrame: On the day of discharge from the hospital, at 6 months, 1 year, 2 years
measure: Predictors of functional outcomes following ACDF in population with predominant neck pain.
timeFrame: On the day of discharge from the hospital, at 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Department of Orthopaedics, J. Dietl Specialist Hospital
state: Lesser Poland Voivodeship
city: Warsaw
country: Poland
facility: Department of Neurosurgery, Medical University of Warsaw
state: Masovian
Study officials:
References: