Chronic Low Back PainNCT02383524
Genetic Predictors of Responsiveness to Radiofrequency Denervation in Chronic Low Back Pain
An observational study of Chronic Low Back Pain, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Lumbar Radiofrequency Medial Branch Neurolysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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)
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's & St Thomas NHS Trust
London, SE1
Stefano Palmisani, MD, stefano.palmisani@gstt.nhs.uk
About this study
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
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.
Read the 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
- Being tested
- Lumbar Radiofrequency Medial Branch Neurolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Radiofrequency Medial Branch NeurolysisProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Chronic Low Back Pain (Lumbar Facet Joints Mediated Pain) | Not described Receives: Procedure: Lumbar Radiofrequency Medial Branch Neurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
Medication intake, Functional status, Ability to work and Quality of life
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Parma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383524
- Sponsor's protocol ID
- 418120
- Status last verified
- Mar 2015
- First submitted
- 4 Mar 2015
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02383524
- Acronym / sponsor ID
- 418120
- Conditions
- Chronic Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Parma
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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])?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Low Back Pain (Lumbar Facet Joints Mediated Pain) | – | Procedure: Lumbar Radiofrequency Medial Branch Neurolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar Radiofrequency Medial Branch NeurolysisNumerous 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 | Procedure or surgery | Chronic Low Back Pain (Lumbar Facet Joints Mediated Pain) |
Primary outcome
Responder Rate
Time frame: 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
1 secondary outcome
Medication intake, Functional status, Ability to work and Quality of life
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Palmisani, MD (+44 (0)2071883237, stefano.palmisani@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.