Back Pain, Low, Degenerative Disc Disease
Conditions
Brief summary
The study aims to identify metabolites present in intervertebral discs colonized by C. acnes from patients with low back pain and degenerative disc disease, correlating them with their clinical, radiological and demographic profiles.
Interventions
PROCEDURELumbar Spinal Fusion Surgery
During surgery will be collected five disc fragments and five fragments of muscle-ligament tissue adjacent to the collected disc.
BIOLOGICALBacterial culture
Samples will be seeded on blood agar and anaerobic blood agar plates. After sowing in solid media, the swab will be inoculated in thioglycolate medium, where it will remain for 14 days
GENETICPhenotypic and genotypic characterization
The phenotypic identification of the species will be carried out through mass spectrometry, with the MALDI-TOF equipment. PCR analyzes performed in two phases, the first to confirm the presence of bacteria (target and non-target) using primers capable of amplifying eubacteria ribosomal deoxyribonucleic acid (rDNA) 16s and the second directed to confirm C. acnes through specific rDNA 16s primers.
GENETICMultiomics analysis
Whole Genome Sequencing, proteomics and metabolomics analysis
Sponsors
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Gaffree & Guinle Universitary Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Neither the patient nor the surgeons will have access to the results of microbiological cultures or molecular analysis. The radiologist who will review the exams will also be blinded to patient data and laboratory results. The researcher who will analyze the pain and function scores will also be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* low back pain lasting longer than 3 months; * MRI findings of degenerative lumbar discopathy (DDL) performed less than 6 months after inclusion in the study; * indication for open surgical treatment, with isolated microdiscectomy or associated with lumbar arthrodesis; * failure of conservative treatment for at least 6 weeks and/or progressive neurological deficit
Exclusion criteria
* History of open lumbar spine surgery at any stage of life; * presence of chemotherapy or pulse therapy with corticoids; * patients with immune deficiency; * patients undergoing previous intradiscal therapies (nucleotomy or discography); * patients undergoing previous endoscopic surgery; * patients with a history of previous spinal infection treated with antibiotics in the 6 months prior to inclusion in the study; * use of antibiotics in the 2 months prior to the surgical procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of C. acnes on intervertebral disc | Up to 5 months | Incidence of C. acnes on intervertebral disc in patients with chronic low back pain and DDL. |
Countries
Brazil
Contacts
Primary ContactVinicius M da Rocha, MD
Outcome results
None listed