Neck PainNCT06601634
Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion
An observational study of Neck Pain and Cervical Spondylosis, run by Medical University of Warsaw at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Cervical Spondylosis, Cervical Disc Disease
- How many people
- 60 participants
- Where
- 2 sitesPoland
- Study dates
- 17 Nov 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Ability to provide informed consent
- Patients who are qualified for one- or two-level ACDF for the treatment of degenerative cervical pathology
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Department of Orthopaedics, J. Dietl Specialist Hospital
Krakow, Lesser Poland Voivodeship, 30-119
Jan Chrzanowski, MD, +48510742795, jan.chrzanowski@uckwum.pl
- Recruiting
Department of Neurosurgery, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-097
Jan Chrzanowski, MD, +48510742795, jan.chrzanowski@uckwum.pl
About this study
Official title: Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion - Prospective, Observational Study
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.
- Conditions
- Neck Pain, Cervical Spondylosis, Cervical Disc Disease
- Medical subject headings
- Neck Pain, Spondylosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: On the day of discharge from the hospital, at 6 months, 1 year, 2 years
Predictors of functional outcomes following ACDF.
Change in NDI ( neck disability index), with calculated MCID as 7.5
Measured: On the day of discharge from the hospital, at 6 months, 1 year, 2 years
Secondary outcomes (2)
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)
Measured: 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.
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)
Measured: On the day of discharge from the hospital, at 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Nov 2024
- Primary completion17 Nov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Chrzanowski, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601634
- Sponsor's protocol ID
- WUMStudy
- Status last verified
- Mar 2025
- First submitted
- 14 Sep 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion - Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06601634
- Acronym / sponsor ID
- WUMStudy
- Conditions
- Neck Pain, Cervical Spondylosis, Cervical Disc Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 17 Nov 2024 (actual)
- Primary completion
- 17 Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Ability to provide informed consent
- Patients who are qualified for one- or two-level ACDF for the treatment of degenerative cervical pathology
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Cervical Spondylosis, run by Medical University of Warsaw at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Chrzanowski, MD (+48510742795, jan.chrzanowski@uckwum.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.