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| Name | Class |
|---|---|
| University of Parma | OTHER |
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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.
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])?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Low Back Pain (Lumbar Facet Joints Mediated Pain) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar Radiofrequency Medial Branch Neurolysis | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate | 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Medication intake, Functional status, Ability to work and Quality of life | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-specified Single Nucleotide Polymorphism (SNP) analysis | To evaluate whether any specific and/or combination of SNPs observed could be related with the clinical outcomes measured in this study | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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Patients suffering from chronic and debilitating low back pain with a diagnosis of lumbar zygapophysial joint mediated pain which has not been effectively treated with conservative pharmacological treatment or alternative non-invasive treatments
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Palmisani, MD | Contact | +44 (0)2071883237 | stefano.palmisani@gstt.nhs.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's & St Thomas NHS Trust | Recruiting | London | SE1 | United Kingdom |
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Blood samples
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