Status:
COMPLETED
Epigenetic and Molecular Biomarkers in Chronic Low Back Pain and Modic Changes
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Haukeland University Hospital
University Hospital, Akershus
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Brief Summary
In the present study the investigators aim to examine the presence of bacteria in the disc and Modic Changes (MCs) (bone). A prospective study with 1-year follow-up of two patient populations undergoi...
Detailed Description
Planned analyses Primary analyses: MC1 vs. control (significant growth from disc, yes/no) MC2 vs. control (significant growth from disc, yes/no) Exploratory subgroup analyses: MC1 and MC2 in prev...
Eligibility Criteria
Inclusion
- Patients scheduled for surgery with lumbar spinal fusion with procedures involving moderate to extensive removal of the disc or disc herniation surgery (for cases: MC seen on MRI at the actual level for surgery, for controls: no MC seen on MRI at the actual level for surgery)
- LBP in the area below the 12th rib and above the gluteal folds
- Age \> 18 years
- Written informed consent
Exclusion
- Antibiotic treatment within the preceding one month before surgery
- Use of glucocorticoids the preceding month before surgery
- Small dots (i.e. \<= 5 mm or height \<10% of vertebra) are not included for any cases or control group
- Unwilling to participate
- Contraindications to MRI
Key Trial Info
Start Date :
January 29 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03406624
Start Date
January 29 2018
End Date
May 15 2024
Last Update
June 26 2024
Active Locations (4)
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1
Haukeland University Hospital
Bergen, Norway, 5021
2
Akershus University Hospital
Lørenskog, Norway, 1478
3
Oslo University Hospital Ullevål
Oslo, Norway, 4950
4
Stavanger Universitetssjukehus
Stavanger, Norway