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Report for Clinical Trial NCT02383524

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Does the Brain-derived Neurotrophic Factor Val66Met Gene Polymorphism Predict Inter-individual Variation in Responsiveness Following Lumbar Radiofrequency Denervation? A Single-centre, Prospective, Exploratory Study in Subjects Diagnosed With Zygapophysial Joint Pain

The Investigators have designed this exploratory study in patients suffering from zygapophysial joint mediated pain to investigate if a correlation exists between inter-individual genetic variability (genotype) with treatment response (phenotype). More specifically, the investigators aim to identify any form of correlation between a specific SNP of the BDNF gene (Val66Met) and the effectiveness and/or duration of radiofrequency facet joint neurotomy. The study population is patients suffering from chronic low back pain who have been scheduled for radiofrequency neurotomy following the diagnosis of facet joint mediated pain (using medial branch block test). The investigators will evaluate if a common variant of BDNF gene (Val66Met) can be directly correlated to a significant degree of pain relief following RF treatment, and whether the result of such a procedure can be predicted from a specific genetic profile.

NCT02383524 Chronic Low Back Pain
MeSH: Back Pain Low Back Pain
HPO: Back pain Low back pain

1 Interventions

Name: Lumbar Radiofrequency Medial Branch Neurolysis

Description: Numerous studies have concluded that facet joint pain can be accurately diagnosed if a significant (but temporary) reduction in pain is achieved with a procedure called a Medial Branch Block (MBB). The clinician delivers a targeted injection of local anesthetic to the joint itself, or in close proximity to the medial branch of the posterior rami of the dorsal root. A significant decrease in pain confirms that the pain originates from the facet joint. If or when the pain returns after successful MBB treatment the patient may be considered for radiofrequency denervation (neurotomy) which selectively disrupts the joint's nerve supply and provides longer-term sustained relief

Type: Procedure

Chronic Low Back Pain (Lumbar Facet Joints Mediated Pain)


Primary Outcomes

Description: Number of patients in each group who report 50% reduction in pain on the visual analogue scale 3 months after radiofrequency denervation for lumbar zygapophysial (facet) joint mediated pain

Measure: Responder Rate

Time: 3 months

Secondary Outcomes

Measure: Medication intake, Functional status, Ability to work and Quality of life

Time: 3 months

Other Outcomes

Description: To evaluate whether any specific and/or combination of SNPs observed could be related with the clinical outcomes measured in this study

Measure: Pre-specified Single Nucleotide Polymorphism (SNP) analysis

Time: 3 months

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 V66M

Does the Brain-derived Neurotrophic Factor Val66Met Gene Polymorphism Predict Inter-individual Variation in Responsiveness Following Lumbar Radiofrequency Denervation? --- Val66Met ---

More specifically, the investigators aim to identify any form of correlation between a specific SNP of the BDNF gene (Val66Met) and the effectiveness and/or duration of radiofrequency facet joint neurotomy. --- Val66Met ---

The investigators will evaluate if a common variant of BDNF gene (Val66Met) can be directly correlated to a significant degree of pain relief following RF treatment, and whether the result of such a procedure can be predicted from a specific genetic profile. --- Val66Met ---



HPO Nodes


HPO:
Back pain
Genes 48
EMD HGD LMNA DLL3 PDGFB ATP7B CLCN7 VANGL1 TP53 TMEM43 SEC63 PLEKHM1 SMAD4 CAPN3 SYNE1 MESP2 BRCA2 SMARCB1 ALDH18A1 SUFU PRKCSH FHL1 PALB2 LMNA LRP5 LMX1B NAB2 TCIRG1 PALLD FHL1 NF2 HELLPAR SPAST SYNE2 VCP CFI TBX6 HLA-B BRCA1 STAT6 CFH PRKCSH HTRA1 FLI1 CD46 CDKN2A KRAS VCP
Low back pain
Genes 6
HTRA1 SPAST ALDH18A1 NAB2 TBX6 STAT6