A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Facet Joint Nerve Blocks
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Average Numeric Rating Scale
Study Overview
Brief Summary
- 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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)
Intervention: Lumbar Facet Joint Nerve Block (Procedure)
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)
Intervention: Lumbar Facet Joint Nerve Block (Procedure)
Outcomes
Primary Outcomes
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.
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Laxmaiah Manchikanti, MD
CEO
Pain Management Center of Paducah