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

NCT03432507 | Unknown DMC

• 1 other identifier: 0477-17
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Outcome Measures

Primary Outcomes (1)

• Microbial culture and cytokines levels assessed from inter-vertebral disc samples

  Number of positive microbial culture and pro-inflammatory cytokines levels assessed by real-time PCR from intervertebral disc samples

  two years

Study Arms (2)

disc herniation

patients suffering from disc herniation

Other: PCR

spinal stenosis

patients suffering from spinal stenosis

Other: PCR

Interventions

PCR OTHER

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

disc herniation; spinal stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 adult subjects suffering from radicular pain duo to disc degeneration / herniation or spinal stenosis will be recruited from the orthopedic clinic at the Rambam Health Care Campus.

You may qualify if:

• Age \> 18
• Capable of understanding the purpose and instructions of the study and signing an informed consent.

You may not qualify if:

• \) Patients suffering for disc degeneration / herniation or spinal stenosis, scheduled to undergo lumbar spinal surgery for decompression and/or fusion (discectomy, laminectomy, foraminotomy, fusion).

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

dissected intra-vertebral discs

MeSH Terms

Conditions

Pain

Interventions

Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elon Eisenberg MD Professor of Neurology and Pain Medicine Head, Pain Research Unit Institute of Pain Medicine Rambam Health Care Campus

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 14, 2018
• Study Start: March 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

IL (1)