Epigenetic and Molecular Biomarkers in Chronic Low Back Pain and Modic Changes
CompletedNCT03406624
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 undergoing elective spinal surgery (spinal fusion or disc herniation surgery) will be conducted. Patients previously operated on at index level will also be included, and evaluated as sub-groups. The following tissues are collected: dermis, sub-fascial tissue, nucleus pulposus, annulus fibrosus, and endplates. Endplate and annular biopsies are only performed in patients undergoing fusion surgery. In addition, air samples from the operating theatre during surgery are collected as negative controls. All tissue samples undergoing culturing should be processed within 4 hours of sampling. The time for sampling and culture processing is noted for each sample. Details are available in a published Method article. For each tissue sample, bacterial growth is recorded and the bacteria are identified at species level. Initially, the microbiologist grades the plates as "no growth", "possible contamination", and "significant growth". "Possible contamination" means that the bacteria may be derived from the environment and could have been introduced at any step from the sample is taken to the analyses in the laboratory. Therefore, we have included negative controls in each step. The investigators will perform direct 16S rDNA amplicon nanopore sequencing on all frozen tissue samples and air samples. Nanopore sequence reads are searched against a 16S rDNA database and the read counts per bacterium are evaluated for each sequencing batch containing 96 samples with regard to the included negative and positive controls. Other broad metagenomic methods may be considered, e.g. Illumina sequencing. Since Cutibacterium acnes is considered the main pathogen in this setting, the investigators will also use a specific PCR on all samples. To validate any positive findings, negative DNA extraction control a…
Study details
- Official title
- Epigenetic and Molecular Biomarkers in Chronic Low Back Pain and Modic Changes
- Conditions
- Interventions
- Procedure: Biopsy
- Sponsor
- Oslo University Hospital
- Collaborators
- Haukeland University Hospital; University Hospital, Akershus; Helse Stavanger HF
- Start date
- 2018-01-29
- Primary completion
- 2026-04-03
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Norway
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03406624