NCT02383524

Genetic Predictors of Responsiveness to Radiofrequency Denervation in Chronic Low Back Pain

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Study Hypothesis It is possible to predict individual responsiveness to radiofrequency denervation for zygapophysial (facet) joint mediated pain on the basis of a specific genetic pattern (Single Nucleotide Polymorphism, \[SNP\])?

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
PROCEDURE	Lumbar Radiofrequency Medial Branch Neurolysis	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

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-02-01
• Completion: 2017-02-01
• First posted: 2015-03-09
• Last updated: 2015-03-11

Locations

1 site across 1 country: United Kingdom