Chronic Low Back Pain
Conditions
Brief 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, \[SNP\])?
Interventions
PROCEDURELumbar 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
Sponsors
University of Parma
Guy's and St Thomas' NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with chronic low back pain which is unresponsive to conservative treatment (including suitable analgesics and physical therapy); * Willing to provide consent * Subject is capable of comprehending the patient information sheet and has the capacity to give their informed consent to all study procedures in English * Be 18 years or older at the time of enrolment; * Have specific low back pain that is aggravated by hyperextension and rotation of the spine, with or without hip, buttock or leg pain that does not follow a known dermatomal distribution * Paraspinal Tenderness * A positive response to a uni/bi-lateral MBB\* (a response is considered positive when a subject experiences at least 50% reduction in pain scores after the block, regardless of the duration of pain relief)
Exclusion criteria
* Patients who had had any previous back surgery * Patients who had previous RF treatments for facet joints mediated pain * Patients with another significant cause of low back pain (like spinal stenosis, disc herniation, spondylolisthesis, malignancy, infection or trauma); * Radicular pain (pain with neuropathic characteristics following one or more nerve root distribution) * Patients with bleeding complications or coagulopathy issues; * Concurrent participation in other experimental trials; * Known history of adverse reactions to local anesthetics; * Pregnant or lactating women; * Refusal to provide informed consent for blood banking * Any other complication which in the view of the investigator may interfere with the study procedures or the measurement of the accurate study outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate | 3 months | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Medication intake, Functional status, Ability to work and Quality of life | 3 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pre-specified Single Nucleotide Polymorphism (SNP) analysis | 3 months | To evaluate whether any specific and/or combination of SNPs observed could be related with the clinical outcomes measured in this study |
Countries
United Kingdom
Contacts
Primary ContactStefano Palmisani, MD
Outcome results
None listed