Effectiveness of Lumbar Facet Joint Nerve Blocks

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
ClinicalTrials.gov Identifier:
NCT00355914
First received: July 24, 2006
Last updated: September 27, 2013
Last verified: September 2013
  Purpose
  1. To demonstrate whether:

    i. Facet joint nerve blocks have therapeutic value beyond the duration of local anesthetic effect.

    ii. Adjuvant medications (Sarapin and Depo-steroids) provide additional relief of lumbar 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 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. To determine the adverse event profile in both groups.

Condition Intervention
Low Back Pain
Procedure: Lumbar Facet Joint Nerve Block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Facet Joint Nerve Blocks

Resource links provided by NLM:


Further study details as provided by Pain Management Center of Paducah:

Primary Outcome Measures:
  • Average Numeric Rating Scale [ Time Frame: Baseline, 3, 6, 12, 18, and 24 months post-treatment ] [ Designated as safety issue: No ]
    Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.

  • Oswestry Disability Index [ Time Frame: Baseline, 3, 6, 12, 18, and 24 months post-treatment. ] [ Designated as safety issue: No ]
    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).


Enrollment: 120
Study Start Date: August 2003
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1 Without Steroids
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
Lumbar Facet Joint Nerve Block
Experimental: Group 2 With Steroids
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
Lumbar Facet Joint Nerve Block

Detailed Description:

Primary Outcome Measure(s) To demonstrate a clinically significant difference between the patients treated with adjuvants and those patients randomized to Group I in the pain status, physical, and psychological status and pain at 3, 6, 12, 18and 24 months post treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355914

Locations
United States, Kentucky
Ambulatory Surgery Center
Paducah, Kentucky, United States, 42003
Sponsors and Collaborators
Pain Management Center of Paducah
Investigators
Principal Investigator: Laxmaiah Manchikanti, MD Ambulatory Surgery Center
  More Information

Additional Information:
Publications:
Responsible Party: Laxmaiah Manchikanti, MD, CEO, Pain Management Center of Paducah
ClinicalTrials.gov Identifier: NCT00355914     History of Changes
Other Study ID Numbers: protocol3
Study First Received: July 24, 2006
Results First Received: December 6, 2012
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pain Management Center of Paducah:
Lumbar Facet Joint Nerve Block

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014