Effectiveness of Thoracic Facet Joint Nerve Blocks

NCT00355706 | Completed Results DMC

• 1 other identifier: protocol 5
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To demonstrate whether:
2. 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. 3.To determine the adverse event profile in both groups

Conditions

Low Back Pain

Keywords

chronic low back pain; thoracic facet joint; nerve block

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Opioid Intake

  24 months

Study Arms (2)

Group I - without Steroids

ACTIVE COMPARATOR

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

Procedure: Thoracic facet joint nerve blocks

Group II - with steroid

ACTIVE COMPARATOR

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

Interventions

Thoracic facet joint nerve blocks PROCEDURE

Thoracic medial branch blocks

Also known as: Thoracic medial branch blocks

Group I - without Steroids; Group II - with steroid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pain Management Center of Paducah: lead

Study Sites (1)

Ambulatory Surgery Center

Paducah, Kentucky, 42003, United States

Location

Related Publications (3)

• 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.

  PMID: 22851967 RESULT

• 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.

  PMID: 21102966 DERIVED

• 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.

  PMID: 18690278 DERIVED

Related 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

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Laxmaiah Manchikanti, MD
• Organization: Pain Management Center of Paducah

drm@asipp.org

2705548373

Study Officials

• Laxmaiah Manchikanti, MD

  Ambulatory Surgery Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 25, 2006
• Study Start: August 1, 2003
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2011
• Last Updated: March 10, 2020
• Results First Posted: November 26, 2013

Record last verified: 2020-03

Locations

US (1)