Effectiveness of Thoracic Facet Joint Nerve Blocks

Effectiveness of Thoracic Facet Joint Nerve Blocks: A Randomized, Prospective, Double-Blind Controlled Evaluation

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Thoracic facet joint nerve blocks

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Ambulatory Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I - without Steroids; Thoracic Facet Joint Nerve Blocks with Local Anesthetic(0.25% Bupivacaine)	Procedure: Thoracic facet joint nerve blocks; Thoracic medial branch blocks; Other Names: Thoracic medial branch blocks
Active Comparator: Group II - with steroid; Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine) and Sterioids(0.15 mg of non-particulate betamethasone)	Procedure: Thoracic facet joint nerve blocks; Thoracic medial branch blocks; Other Names: Thoracic medial branch blocks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale	Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.	2 years
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).	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Intake	Opioid intake(morphine equivalence mg)	24 months

Collaborators and Investigators

• Sponsor: Pain Management Center of Paducah
• Investigators: Principal Investigator: Laxmaiah Manchikanti, MD, Ambulatory Surgery Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 24, 2006
• First Submitted That Met QC Criteria: July 24, 2006
• First Posted (Estimate): July 25, 2006

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: chronic low back pain; nerve block; thoracic facet joint
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Protocol 5