Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-28 @ 11:56 PM
Study NCT ID:
NCT00355706
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2006-07-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Thoracic Facet Joint Nerve Blocks
Sponsor:
Pain Management Center of Paducah
Organization:
Study Overview
Official Title:
Effectiveness of Thoracic Facet Joint Nerve Blocks: A Randomized, Prospective, Double-Blind Controlled Evaluation
Status:
COMPLETED
Status Verified Date:
2020-03
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:
1. To demonstrate whether:
i. Facet joint nerve blocks have therapeutic value beyond the duration of local anesthetic effect.
ii. Addition of Depo-steroid provides additional relief of thoracic facet joint pain when used with facet joint nerve blocks.
2. To demonstrate whether or not there are clinically significant improvements in function of patients who receive thoracic facet joint nerve block with Depo-steroid compared to patients randomized to Group I who receive only local anesthetic blocks.
3. To determine the adverse event profile in both groups
i. Facet joint nerve blocks have therapeutic value beyond the duration of local anesthetic effect.
ii. Addition of Depo-steroid provides additional relief of thoracic facet joint pain when used with facet joint nerve blocks.
2. To demonstrate whether or not there are clinically significant improvements in function of patients who receive thoracic facet joint nerve block with Depo-steroid compared to patients randomized to Group I who receive only local anesthetic blocks.
3. To determine the adverse event profile in both groups
Detailed Description:
Participants Study participants were recruited at the interventional pain management practice from consecutive new patients presenting with thoracic pain. One hundred patients were included and randomly assigned to one of 2 groups; either a local anesthetic only group (Group I) or a local anesthetic with steroid group (Group II), with 50 patients in each group. Patients meeting the inclusion criteria were eligible to undergo diagnostic thoracic facet joint nerve blocks. Only patients positive for controlled comparative local anesthetic blocks met the criteria for inclusion for thoracic medial branch blocks.
Inclusion and Exclusion Criteria Only patients with nonspecific mid-back or upper back pain without suspected disc herniation, radiculitis, thoracic fracture, stenosis, or intercostal neuritis were included. Further, patients suspected of disc-related pain with radicular symptoms were also excluded, based on radiologic testing and symptomatology involving radicular or chest wall pain. Patients also should have previously received conservative management with physical therapy, chiropractic manipulation exercises, drug therapy, and bed rest, and so forth, but continued to have pain.
Further inclusion criteria were a diagnosis of thoracic facet joint pain by means of controlled comparative local anesthetic blocks; patients who were over 18 years of age; patients with a history of chronic function-limiting mid-back or upper back pain of at least 6 months duration; and patients who where competent to understand the study protocol and provide voluntary, written informed consent, and participate in the outcome measurements. A negative or false-positive response to controlled comparative local anesthetic blocks, uncontrollable to heavy opioid use (morphine equivalent of 300 mg), uncontrolled
Inclusion and Exclusion Criteria Only patients with nonspecific mid-back or upper back pain without suspected disc herniation, radiculitis, thoracic fracture, stenosis, or intercostal neuritis were included. Further, patients suspected of disc-related pain with radicular symptoms were also excluded, based on radiologic testing and symptomatology involving radicular or chest wall pain. Patients also should have previously received conservative management with physical therapy, chiropractic manipulation exercises, drug therapy, and bed rest, and so forth, but continued to have pain.
Further inclusion criteria were a diagnosis of thoracic facet joint pain by means of controlled comparative local anesthetic blocks; patients who were over 18 years of age; patients with a history of chronic function-limiting mid-back or upper back pain of at least 6 months duration; and patients who where competent to understand the study protocol and provide voluntary, written informed consent, and participate in the outcome measurements. A negative or false-positive response to controlled comparative local anesthetic blocks, uncontrollable to heavy opioid use (morphine equivalent of 300 mg), uncontrolled
Study Oversight
Has Oversight DMC:
True
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?: