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Effectiveness of Thoracic Facet Joint Nerve Blocks

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thoracic facet joint nerve blocks
Sponsored by
Pain Management Center of Paducah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring chronic low back pain, thoracic facet joint, nerve block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Positive for facet joint pain with comparative local anesthetic blocks Candidates are over 18 years of age Subjects with a history of chronic, function limiting neck pain of at least six months in duration Subjects who are able to give voluntary, written informed consent to participate in this investigation Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the center for all the required post-operative follow-ups The subject has not had recent surgical procedures within the last three months. - Exclusion Criteria: Negative or false-positive response to controlled comparative local anesthetic blocks Narcotic use of greater than Hydrocodone 100 mg/day, Methadone 80 mg or Morphine 100 mg, or dose equivalent Uncontrolled major Depression or uncontrolled psychiatric disorders Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intercranial pressure, pseudotumor cerebri, intercranial tumors, unstable angina, and severe chronic obstructive pulmonary disease. Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function Women who are pregnant or lactating Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment Patients with multiple complaints involving concomitant hip osteoarthritis, will not be amenable to study due to the overlap of pain complaints. Inability to achieve appropriate positioning and inability to understand informed consent and protocol History of adverse reaction to local anesthetic or anti-inflammatory drugs

Sites / Locations

  • Ambulatory Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I - without Steroids

Group II - with steroid

Arm Description

Thoracic Facet Joint Nerve Blocks with Local Anesthetic(0.25% Bupivacaine)

Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine) and Sterioids(0.15 mg of non-particulate betamethasone)

Outcomes

Primary Outcome Measures

Numeric Rating Scale
Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.
Oswestry Disability Index
Oswestry Disability Index (ODI) - ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 (these patients are either bed-bound or exaggerating their symptoms).

Secondary Outcome Measures

Full Information

First Posted
July 24, 2006
Last Updated
March 2, 2020
Sponsor
Pain Management Center of Paducah
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1. Study Identification

Unique Protocol Identification Number
NCT00355706
Brief Title
Effectiveness of Thoracic Facet Joint Nerve Blocks
Official Title
Effectiveness of Thoracic Facet Joint Nerve Blocks: A Randomized, Prospective, Double-Blind Controlled Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pain Management Center of Paducah

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
chronic low back pain, thoracic facet joint, nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I - without Steroids
Arm Type
Active Comparator
Arm Description
Thoracic Facet Joint Nerve Blocks with Local Anesthetic(0.25% Bupivacaine)
Arm Title
Group II - with steroid
Arm Type
Active Comparator
Arm Description
Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine) and Sterioids(0.15 mg of non-particulate betamethasone)
Intervention Type
Procedure
Intervention Name(s)
Thoracic facet joint nerve blocks
Other Intervention Name(s)
Thoracic medial branch blocks
Intervention Description
Thoracic medial branch blocks
Primary Outcome Measure Information:
Title
Numeric Rating Scale
Description
Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.
Time Frame
2 years
Title
Oswestry Disability Index
Description
Oswestry Disability Index (ODI) - ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 (these patients are either bed-bound or exaggerating their symptoms).
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Opioid Intake
Description
Opioid intake(morphine equivalence mg)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Positive for facet joint pain with comparative local anesthetic blocks Candidates are over 18 years of age Subjects with a history of chronic, function limiting neck pain of at least six months in duration Subjects who are able to give voluntary, written informed consent to participate in this investigation Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the center for all the required post-operative follow-ups The subject has not had recent surgical procedures within the last three months. - Exclusion Criteria: Negative or false-positive response to controlled comparative local anesthetic blocks Narcotic use of greater than Hydrocodone 100 mg/day, Methadone 80 mg or Morphine 100 mg, or dose equivalent Uncontrolled major Depression or uncontrolled psychiatric disorders Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intercranial pressure, pseudotumor cerebri, intercranial tumors, unstable angina, and severe chronic obstructive pulmonary disease. Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function Women who are pregnant or lactating Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment Patients with multiple complaints involving concomitant hip osteoarthritis, will not be amenable to study due to the overlap of pain complaints. Inability to achieve appropriate positioning and inability to understand informed consent and protocol History of adverse reaction to local anesthetic or anti-inflammatory drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laxmaiah Manchikanti, MD
Organizational Affiliation
Ambulatory Surgery Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ambulatory Surgery Center
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22851967
Citation
Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V, Fellows B. The role of thoracic medial branch blocks in managing chronic mid and upper back pain: a randomized, double-blind, active-control trial with a 2-year followup. Anesthesiol Res Pract. 2012;2012:585806. doi: 10.1155/2012/585806. Epub 2012 Jul 19.
Results Reference
result
PubMed Identifier
21102966
Citation
Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V, Fellows B. Comparative effectiveness of a one-year follow-up of thoracic medial branch blocks in management of chronic thoracic pain: a randomized, double-blind active controlled trial. Pain Physician. 2010 Nov-Dec;13(6):535-48.
Results Reference
derived
PubMed Identifier
18690278
Citation
Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Effectiveness of thoracic medial branch blocks in managing chronic pain: a preliminary report of a randomized, double-blind controlled trial. Pain Physician. 2008 Jul-Aug;11(4):491-504.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3407605/pdf/ARP2012-585806.pdf
Description
The Role of Thoracic Medial Branch Blocks in Managing Chronic Mid and Upper Back Pain: A Randomized, Double-Blind, Active-Control Trial with a 2-Year Followup

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Effectiveness of Thoracic Facet Joint Nerve Blocks

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