Periduroscopy: Correlation Between the Outcome of Procedure and Histological-biochemical, Neuroinflammation and Genetic Factors.
Unknown statusNCT02076035
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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)
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 h…
Study details
- Official title
- A Prospective Study to Analyze, in a Population Undergoing to a Periduroscopy Approach, the Correlation Between Outcome of Procedure and Histological-biochemical Neuroinflammation and Genetic Factors
- Conditions
- Sponsor
- University of Parma
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Start date
- 2014-04
- Primary completion
- 2017-04
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age: 18 - 75 years * Patients undergone periduroscopy procedure according to good clinical practice. * Written informed consent signed Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02076035