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The Association Between Proinflammatory Cytokines, Microbial Infection and Clinical Manifestation in Sciatica Patients

NCT03432507 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2018-04-24

No results posted yet for this study

Summary

All patients scheduled for lumbar spine surgery due to discogenic low back pain and/or sciatica, will be screened by the principal investigator for presence of inclusion/exclusion criteria. Their baseline neurological function before surgery will be assessed and recorded for recruitment into one of the three study groups. MRI scans will be assessed for the calculation of disc protrusion size. Experimental sensory and pain assessments and questionnaires will be performed at list 24 hours before surgery. Blood sample for pro-inflammatory mediator will be obtained at the same time as the experimental sensory and pain tests. Pre-operative pain and MPQ will be assessed pre-operatively (back and leg pain separately), and again on day 30 after surgery. Blood tests for ESR, CRP will be drawn before surgery, during the surgery, and on 30 after surgery. During surgery, intervertebral disc material will be harvested and divided into 4 specimens for culture and inflammatory mediator analysis. Repeat neurological assessment will be performed 30 after surgery.

Conditions

Interventions

OTHER

PCR

PCR for proinflammatory cytokines (IL-1b, IL-6, IL-8, IL-17, TNF-a, INF-g) and bacteria

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-12-01
Completion
2019-12-01

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03432507 on ClinicalTrials.gov