Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484159
Status:
COMPLETED
Last Update Posted:
2011-07-26
First Post:
2007-06-06
Brief Title:
Efficacy and Cost Benefit Ratio of 0 1 and 2 Medial Branch Blocks for Lumbar Facet Joint Radiofrequency Denervation
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 05 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 05 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
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 05 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 05 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None