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Effectiveness of Lumbar Facet Joint Nerve Blocks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00355914
Recruitment Status : Completed
First Posted : July 25, 2006
Results First Posted : November 26, 2013
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah

Study Description
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Brief Summary:

  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 or disease Intervention/treatment Phase
Low Back Pain Procedure: Lumbar Facet Joint Nerve Block Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Facet Joint Nerve Blocks
Study Start Date : August 2003
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006
Arms and Interventions
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Arm Intervention/treatment
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


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

  2. Oswestry Disability Index [ Time Frame: Baseline, 3, 6, 12, 18, and 24 months post-treatment. ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355914


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

Publications of Results:

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Responsible Party: Laxmaiah Manchikanti, MD, CEO, Pain Management Center of Paducah
ClinicalTrials.gov Identifier: NCT00355914    
Other Study ID Numbers: protocol3
First Posted: July 25, 2006    Key Record Dates
Results First Posted: November 26, 2013
Last Update Posted: November 26, 2013
Last Verified: September 2013
Keywords provided by Laxmaiah Manchikanti, MD, Pain Management Center of Paducah:
Lumbar Facet Joint Nerve Block
Additional relevant MeSH terms:
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Low Back Pain
Back Pain
Pain
Neurologic Manifestations