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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02383524
• Other study ID #: 418120
• Status: Recruiting
• Phase: N/A
• First received: March 4, 2015
• Last updated: March 10, 2015
• Start date: February 2015
• Est. completion date: February 2017

Study information

• Verified date: March 2015
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Stefano Palmisani, MD
• Phone: +44 (0)2071883237
• Email: stefano.palmisani[@]gstt.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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])?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Guy's & St Thomas NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	University of Parma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	Medication intake, Functional status, Ability to work and Quality of life		3 months	No