Effectiveness of Lumbar Facet Joint Nerve Blocks
A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Facet Joint Nerve Blocks
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.
- 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.
- To determine the adverse event profile in both groups.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kentucky
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Paducah, Kentucky, United States, 42003
- Ambulatory Surgery Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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)
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Lumbar Facet Joint Nerve Block
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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)
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Lumbar Facet Joint Nerve Block
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average Numeric Rating Scale
Time Frame: Baseline, 3, 6, 12, 18, and 24 months post-treatment
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Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.
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Baseline, 3, 6, 12, 18, and 24 months post-treatment
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Oswestry Disability Index
Time Frame: Baseline, 3, 6, 12, 18, and 24 months post-treatment.
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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).
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Baseline, 3, 6, 12, 18, and 24 months post-treatment.
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Collaborators and Investigators
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. 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- protocol3
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