Effectiveness of Lumbar Facet Joint Nerve Blocks

NCT00355914 | Completed Results DMC

• 1 other identifier: protocol3
• Study Type: interventional
• Target: 120
• 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 lumbar facet joint nerve block with or without Sarapin and Depo-steroids (Group II) 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

Lumbar Facet Joint Nerve Block

Outcome Measures

Primary Outcomes (2)

• Average Numeric Rating Scale

  Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.

  Baseline, 3, 6, 12, 18, and 24 months post-treatment

• Oswestry Disability Index

  Oswestry Disability Index 2.0 (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% (may be bed bound or exaggerating their symptoms).

  Baseline, 3, 6, 12, 18, and 24 months post-treatment.

Study Arms (2)

Group 1 Without Steroids

ACTIVE COMPARATOR

Lumbar Facet Joint Nerve Block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)

Procedure: Lumbar Facet Joint Nerve Block

Group 2 With Steroids

EXPERIMENTAL

Lumbar Facet Joint Nerve Block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)

Procedure: Lumbar Facet Joint Nerve Block

Interventions

Lumbar Facet Joint Nerve Block PROCEDURE

Lumbar Facet Joint Nerve Block

Group 1 Without Steroids; Group 2 With Steroids

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 low back 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. Evaluation of lumbar facet joint nerve blocks in managing chronic low back pain: a randomized, double-blind, controlled trial with a 2-year follow-up. Int J Med Sci. 2010 May 28;7(3):124-35. doi: 10.7150/ijms.7.124.

  PMID: 20567613 RESULT

• Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Lumbar facet joint nerve blocks in managing chronic facet joint pain: one-year follow-up of a randomized, double-blind controlled trial: Clinical Trial NCT00355914. Pain Physician. 2008 Mar-Apr;11(2):121-32.

  PMID: 18354721 RESULT

• Manchikanti L, Manchikanti KN, Manchukonda R, Cash KA, Damron KS, Pampati V, McManus CD. Evaluation of lumbar facet joint nerve blocks in the management of chronic low back pain: preliminary report of a randomized, double-blind controlled trial: clinical trial NCT00355914. Pain Physician. 2007 May;10(3):425-40.

  PMID: 17525777 RESULT

Related Links

• Evaluation of lumbar facet joint nerve blocks in managing chronic low back pain: a randomized, double-blind, controlled trial with a 2-year follow-up.

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, Paducah, KY

drlm@thepainmd.com

2705548373

Study Officials

• Laxmaiah Manchikanti, MD

  Ambulatory Surgery Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO

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, 2006
• Last Updated: November 26, 2013
• Results First Posted: November 26, 2013

Record last verified: 2013-09

Locations

US (1)