Low Back PainNCT00484159
Efficacy and Cost: Benefit Ratio of 0, 1, and 2 Medial Branch Blocks for Lumbar Facet Joint Radiofrequency Denervation
A study testing Radiofrequency denervation of medial branches, 0.5% bupivacaine and 2% lidocaine in people with Low Back Pain, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Lumbar zygapophysial (facet) joint pain is a common cause of low back pain. Radiofrequency (RF) denervation is an effective and low risk treatment of chronic low back pain of suspected facet joint etiology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Radiofrequency denervation of medial branches, 0.5% bupivacaine and 2% lidocaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2007to Jan 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Axial low back pain unresponsive to conservative treatment measures such as physical therapy, manual therapy and pharmacotherapy
- Duration of pain greater than 6 months
Who cannot join
- Age younger than 18 years
- Objective evidence (MRI or physical exam findings) of lumbosacral radiculopathy
- Prior radiofrequency treatment
- Significant spinal stenosis or spondylolisthesis
- Previous back surgery
- Uncorrected coagulopathy
Show all 9Show fewer
- Unstable medical or psychiatric condition
- Pregnancy
- Allergies to local anesthetic
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
Official title: Prospective Randomized Study Comparing 0, 1, and 2 Diagnostic Lumbar Medial Branch (Facet Joint) Blocks Before Radiofrequency Denervation in Patients With Chronic Low Back Pain: A Cost: Benefit Analysis.
Lumbar zygapophysial (facet) joint pain is a common cause of low back pain. Radiofrequency (RF) denervation is an effective and low risk treatment of chronic low back pain of suspected facet joint etiology. Blocks of the medial branches innervating the joints are commonly used to localize the pain and make the diagnosis of facet joint pain.
There is currently no standard number of diagnostic blocks: zero, one, and two blocks have all been utilized. Considering the high false positive and false negative rates of these blocks, the cost: benefit ratio has been questioned. No study to date has examined the practice of diagnostic medial branch blocks before RF denervation.
The purpose of this study is to determine the optimal number of blocks before radiofrequency denervation. Three groups of patients will be studied. In group I, patients will undergo RF denervation based on history and physical exam alone. In group II, patients will undergo RF denervation based on a positive response to a single diagnostic block with local anesthetic. In group III, patients will undergo RF treatment only after a positive screening block and a positive confirmatory block.
Read the detailed description
Lumbar zygapophysial (facet) joints are recognized as one of the most common causes of chronic low back pain with an estimated prevalence among patients with LBP ranging from 15% to 40%. Radiofrequency (RF) denervation of facet joints has been utilized as an effective treatment of chronic pain attributed to these joints. Blocks of the medial branches innervating the joints are commonly used to localize the pain and make a diagnosis of lumbar zygapophysial (l-z) joint pain. However, considering the high false-positive rates of these blocks (25-40%), the false-negative rates (8-10%), and the number of blocks necessary to make the diagnosis before treatment, the cost-effectiveness of performing these blocks and the benefit of exposing these patients to additional risks is under question. The risks of RF denervation are so low (equivalent to performing the diagnostic block), some have questioned whether or not any diagnostic facet blocks should be performed before RF lesioning.
The purpose of the study is to determine the optimal number of diagnostic blocks that should be performed before radiofrequency denervation in patients with chronic lower back pain with suspected facet joint etiology.
In this prospective randomized study, we will recruit 150 patients with suspected chronic (l-z) joint pain without neurological symptoms to undergo one of three treatment modalities. In group I, 50 patients will undergo RF denervation based on history and physical exam alone (what we advocate in a recent review article). In group II, 50 patients will receive a single diagnostic block with 0.5% bupivacaine. Those that obtain greater than 50% pain reduction will undergo RF denervation. In group III, 50 patients will receive a block with either 2% lidocaine or 0.5% bupivacaine. Those patients that obtain greater than 50% pain relief with the first block receive a second block with the other local anesthetic. Patients that obtain greater than 50% pain relief with the second block then undergo RF. Patients in any group that obtain less than 50% pain relief with any block exit the study.
- Conditions
- Low Back Pain
- Being tested
- Radiofrequency denervation of medial branches, 0.5% bupivacaine, 2% lidocaine, Radiofrequency denervation
- Keywords
- Low back pain of suspected lumbar zygapophysial etiology
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency denervation of medial branchesProcedure or surgery
Radiofrequency of medial branches that innervate the lumbar facet joints
0.5% bupivacaineDrug
Diagnostic medial branch block with 0.5% bupivacaine. Blocking the nerves that innervate the facet joints with a long-acting local anesthetic.
2% lidocaineDrug
Diagnostic medial branch block with 2% lidocaine. Blocking the nerves that innervate the facet joints with a short-acting local anesthetic.
Radiofrequency denervationProcedure or surgery
Radiofrequency lumbar facet denervation without a diagnostic block
Radiofrequency denervationProcedure or surgery
Radiofrequency lumbar facet denervation only if positive response to 2 diagnostic blocks.
Radiofrequency denervationProcedure or surgery
Lumbar facet radiofrequency denervation if positive response to a single diagnostic facet block
Radiofrequency denervationProcedure or surgery
Radiofrequency lumbar facet denervation without a diagnostic facet block.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks. Receives: Procedure: Radiofrequency denervation of medial branches; Drug: 0.5% bupivacaine; Drug: 2% lidocaine; Procedure: Radiofrequency denervation |
| 2 | Experimental | Radiofrequency lumbar facet joint denervation if positive response to single facet joint block. Receives: Procedure: Radiofrequency denervation of medial branches; Drug: 0.5% bupivacaine; Procedure: Radiofrequency denervation |
| 3 | Experimental | Radiofrequency lumbar facet denervation without a diagnostic facet block. Receives: Procedure: Radiofrequency denervation of medial branches; Procedure: Radiofrequency denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost Per Successful Procedure
Total cost per effective treatment at 3-months. Successful procedure defined as greater or equal to 50% pain relief and satisfaction lasting at least 3 months.
Measured: 3-months
Secondary outcomes (1)
Successful Treatment
Greater or equal to 50% pain relief plus procedural satisfaction lasting at least 3 months. What is being measured is the number of participants with a positive outcome.
Measured: 3-months postprocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startFeb 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Investigators
- Steven P Cohen, MD, Principal investigator, Johns Hopkins School of Medicine, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484159
- Sponsor's protocol ID
- NA_00007158
- Status last verified
- Jan 2009
- First submitted
- 6 Jun 2007
- Last updated
- 26 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing 0, 1, and 2 Diagnostic Lumbar Medial Branch (Facet Joint) Blocks Before Radiofrequency Denervation in Patients With Chronic Low Back Pain: A Cost: Benefit Analysis.
- ClinicalTrials.gov ID
- NCT00484159
- Acronym / sponsor ID
- NA_00007158
- Conditions
- Low Back Pain
- Keywords
- Low back pain of suspected lumbar zygapophysial etiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 8 Jun 2007 (estimated)
- Results
- Posted 21 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lumbar zygapophysial (facet) joint pain is a common cause of low back pain. Radiofrequency (RF) denervation is an effective and low risk treatment of chronic low back pain of suspected facet joint etiology. Blocks of the medial branches innervating the joints are commonly used to localize the pain and make the diagnosis of facet joint pain.
There is currently no standard number of diagnostic blocks: zero, one, and two blocks have all been utilized. Considering the high false positive and false negative rates of these blocks, the cost: benefit ratio has been questioned. No study to date has examined the practice of diagnostic medial branch blocks before RF denervation.
The purpose of this study is to determine the optimal number of blocks before radiofrequency denervation. Three groups of patients will be studied. In group I, patients will undergo RF denervation based on history and physical exam alone. In group II, patients will undergo RF denervation based on a positive response to a single diagnostic block with local anesthetic. In group III, patients will undergo RF treatment only after a positive screening block and a positive confirmatory block.
Detailed description
Lumbar zygapophysial (facet) joints are recognized as one of the most common causes of chronic low back pain with an estimated prevalence among patients with LBP ranging from 15% to 40%. Radiofrequency (RF) denervation of facet joints has been utilized as an effective treatment of chronic pain attributed to these joints. Blocks of the medial branches innervating the joints are commonly used to localize the pain and make a diagnosis of lumbar zygapophysial (l-z) joint pain. However, considering the high false-positive rates of these blocks (25-40%), the false-negative rates (8-10%), and the number of blocks necessary to make the diagnosis before treatment, the cost-effectiveness of performing these blocks and the benefit of exposing these patients to additional risks is under question. The risks of RF denervation are so low (equivalent to performing the diagnostic block), some have questioned whether or not any diagnostic facet blocks should be performed before RF lesioning.
The purpose of the study is to determine the optimal number of diagnostic blocks that should be performed before radiofrequency denervation in patients with chronic lower back pain with suspected facet joint etiology.
In this prospective randomized study, we will recruit 150 patients with suspected chronic (l-z) joint pain without neurological symptoms to undergo one of three treatment modalities. In group I, 50 patients will undergo RF denervation based on history and physical exam alone (what we advocate in a recent review article). In group II, 50 patients will receive a single diagnostic block with 0.5% bupivacaine. Those that obtain greater than 50% pain reduction will undergo RF denervation. In group III, 50 patients will receive a block with either 2% lidocaine or 0.5% bupivacaine. Those patients that obtain greater than 50% pain relief with the first block receive a second block with the other local anesthetic. Patients that obtain greater than 50% pain relief with the second block then undergo RF. Patients in any group that obtain less than 50% pain relief with any block exit the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Radiofrequency denervation of medial branches, Drug: 0.5% bupivacaine, Drug: 2% lidocaine, Procedure: Radiofrequency denervationRadiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks. |
| 2 | Experimental | Procedure: Radiofrequency denervation of medial branches, Drug: 0.5% bupivacaine, Procedure: Radiofrequency denervationRadiofrequency lumbar facet joint denervation if positive response to single facet joint block. |
| 3 | Experimental | Procedure: Radiofrequency denervation of medial branches, Procedure: Radiofrequency denervationRadiofrequency lumbar facet denervation without a diagnostic facet block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Axial low back pain unresponsive to conservative treatment measures such as physical therapy, manual therapy and pharmacotherapy
- Duration of pain greater than 6 months
Key exclusion criteria (9 listed)
- Age younger than 18 years
- Objective evidence (MRI or physical exam findings) of lumbosacral radiculopathy
- Prior radiofrequency treatment
- Significant spinal stenosis or spondylolisthesis
- Previous back surgery
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 |
|---|---|---|
| Radiofrequency denervation of medial branchesRadiofrequency of medial branches that innervate the lumbar facet joints | Procedure or surgery | 1, 2, 3 |
| 0.5% bupivacaineDiagnostic medial branch block with 0.5% bupivacaine. Blocking the nerves that innervate the facet joints with a long-acting local anesthetic. | Drug | 1, 2 |
| 2% lidocaineDiagnostic medial branch block with 2% lidocaine. Blocking the nerves that innervate the facet joints with a short-acting local anesthetic. | Drug | 1 |
| Radiofrequency denervationRadiofrequency lumbar facet denervation without a diagnostic block | Procedure or surgery | 3 |
| Radiofrequency denervationRadiofrequency lumbar facet denervation only if positive response to 2 diagnostic blocks. | Procedure or surgery | 1 |
| Radiofrequency denervationLumbar facet radiofrequency denervation if positive response to a single diagnostic facet block | Procedure or surgery | 2 |
| Radiofrequency denervationRadiofrequency lumbar facet denervation without a diagnostic facet block. | Procedure or surgery | 3 |
Primary outcome
Cost Per Successful Procedure
Time frame: 3-months
Total cost per effective treatment at 3-months. Successful procedure defined as greater or equal to 50% pain relief and satisfaction lasting at least 3 months.
1 secondary outcome
Successful Treatment
Time frame: 3-months postprocedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Steven P Cohen, MD principal investigator
Johns Hopkins School of Medicine, Walter Reed Army Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency denervation of medial branches, 0.5% bupivacaine and 2% lidocaine in people with Low Back Pain, run by Johns Hopkins University at 2 sites in United States.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost Per Successful Procedure (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 26 Jul 2011; AzTrials last refreshed its copy on 7 Nov 2026.