Periduroscopy: Correlation Between the Outcome of Procedure and Histological-biochemical, Neuroinflammation and Genetic Factors.

NCT02076035 | Unknown

• 1 other identifier: Pain-Omics Periduroscopy
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

It is still unknown the pathogenesis of low back pain and a lot of hypothesis were discussed for a long time. Because non-invasive imaging modalities greatly underestimate the prevalence of epidural pathogenesis an endoscopic examination of the epidural space has been advocated as both a diagnostic and therapeutic modality. It seems that immune-inflammatory factors play a more substantial role in pain status. Myeloscopic investigation have shown how morphological pictures of the epidural area in patients with chronic low back pain (CLBP) are much more complex and heterogeneous than what can be identified with traditional investigation suggesting a biochemical involvement. Endoscopy of the epidural space (epiduroscopy) is a minimally invasive technique, used to directly visualize pathological features inside of the lumbar spinal canal to locate tissues responsible of eliciting pain and the presence of any pathological structures within the vertebral channel, such as fibrous adherences, inflammatory processes, severe fibrosis and/or stenoses, in order to realize an effective therapeutic approach in a lot of different CLBP status as those due to spinal stenoses or failed back surgery syndrome. To deepen the molecular causes of interindividual variability of epiduroscopy outcomes in terms of decrease of pain, it is useful to analyze the DNA variants encoding IL6 and IL1 cytokines and to relate them with gene expression levels and with the cytokine dosage. By this technique, it is possible to analyze in the biopsy of the epidural tissue the specific expression of the cytokines: there is already evidence that inflammatory factors may be involved in the genesis of LBP. At this regards, it would be really important to compare systemic cytokine levels before the epiduroscopy with those detected immediately post procedure and after one month, to understand if the cytokines could play a key role and be a biomarker of the epiduroscopy outcome. Concerning DNA polymorphisms, it has been demonstrated, in many disease-state meta-analyses, that the IL6 variant rs1800795 affect gene transcription and influences the IL-6 levels. Moreover, interleukin 1 (IL-1) is a major factor controlling the inflammatory response. The IL-1 gene family includes the IL-1α, IL-1β and the IL-1 receptor antagonist (IL-1Ra) genes that mediate immune and inflammatory responses. SNPs in IL-1α, IL-1β and IL1Ra modify bone mineral density promoting intervertebral disc disease (IDD). The simultaneous carriage of the IL-1bT3954 and the IL-1Ra A1812 alleles significantly enhances the risk of low back pain (LBP) occurrence, the number of days with pain, and the number of days with limitations in daily activities due to pain. A recent study suggested that methylation status of a single CpG site in the IL6 promoter is related to IL6 messenger RNA levels and that lower methylation contributes to the risk of developing Rheumatoid Arthritis. The investigators will try to identify if it there is a correlation with success of the epiduroscopy approach in terms of freedom from pain with genic expression and cytokine dosage. Finally, the investifators will compare the cytokine gene expression and the DNA methylation status of IL6 promoter in patients with favorable outcome and in no responders, to study the role in gene expression. This study is addressed to detect if the genetic variability might be used in near future in clinical setting, to predict the success of epiduroscopy.

Conditions

Chronic Low Back Pain

Keywords

low back pain; periduroscopy; genetic; genomic; inflammation

Outcome Measures

Primary Outcomes (1)

• genetic outcome

  the frequency of rs1800795 in the promoter of the IL6 gene

  36 months

Secondary Outcomes (5)

• genomic outcome

  36 months

• inflammation outcome

  36 months

• gene expression outcome

  36 months

• biopsy tissue outcome

  36 months

• methylation outcome

  36 months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will enroll a well phenotyped cohort of patients with chronic low back pain, sub-grouped into categories: spinal stenosis (congenital or acquired) and failed back surgery syndrome.

You may qualify if:

• Age: 18 - 75 years
• Patients undergone periduroscopy procedure according to good clinical practice.
• Written informed consent signed

You may not qualify if:

• Subjects with evidence of clinically unstable disease (without stable treatment that needs continuous pharmacological and drugs dosage changes; physicians requiring further assessments; at instance not-responder hypertension to the pharmacological treatment with pressure values constantly alterated despite the therapy)
• Subjects with a severe psychiatric disorder diagnosed by a psychiatrist and / or neurologist, that are/have been under a pharmacological treatment and under specialist control with particular contraindications to invasive treatments
• Mental impaired patients
• History of spinal fracture
• Spinal tumor or infection of column;
• Visual alterations (glaucoma, diabetic retinopathy)
• Brain vascular disease
• Primary or secondary chronic headache
• For women: positive pregnancy test or pregnancy.
• Coagulopathy (INR\>1.5)
• Refusal to participate

Sponsors & Collaborators

• University of Parma: lead
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator

Study Sites (1)

University of Parma

Parma, Parma, 43100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

3 whole blood samples will be collected: before epiduroscopy, immediately after it and after a month for genetic analyses and cytokine dosage. An epidural bioptic sample will be performed according to usual clinical practice

MeSH Terms

Conditions

Low Back Pain; Inflammation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Guido Fanelli, Professor

CONTACT

+39 0521 703567; guido.fanelli@unipr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 3, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: December 31, 2014

Record last verified: 2014-02

Locations

IT (1)