Effectiveness of Lumbar Facet Joint Nerve Blocks
Effectiveness of Lumbar Facet Joint Nerve Blocks
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.
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.
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