Effectiveness of Thoracic Facet Joint Nerve Blocks
Effectiveness of Thoracic Facet Joint Nerve Blocks
1. To demonstrate whether:

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

 ii. Addition of Depo-steroid provides additional relief of thoracic 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 thoracic facet joint nerve block with Depo-steroid compared to
 patients randomized to Group I who receive only local anesthetic blocks.

 3. To determine the adverse event profile in both groups
Participants Study participants were recruited at the interventional pain management practice
 from consecutive new patients presenting with thoracic pain. One hundred patients were
 included and randomly assigned to one of 2 groups; either a local anesthetic only group
 (Group I) or a local anesthetic with steroid group (Group II), with 50 patients in each
 group. Patients meeting the inclusion criteria were eligible to undergo diagnostic thoracic
 facet joint nerve blocks. Only patients positive for controlled comparative local anesthetic
 blocks met the criteria for inclusion for thoracic medial branch blocks.

 Inclusion and Exclusion Criteria Only patients with nonspecific mid-back or upper back pain
 without suspected disc herniation, radiculitis, thoracic fracture, stenosis, or intercostal
 neuritis were included. Further, patients suspected of disc-related pain with radicular
 symptoms were also excluded, based on radiologic testing and symptomatology involving
 radicular or chest wall pain. Patients also should have previously received conservative
 management with physical therapy, chiropractic manipulation exercises, drug therapy, and bed
 rest, and so forth, but continued to have pain.

 Further inclusion criteria were a diagnosis of thoracic facet joint pain by means of
 controlled comparative local anesthetic blocks; patients who were over 18 years of age;
 patients with a history of chronic function-limiting mid-back or upper back pain of at least
 6 months duration; and patients who where competent to understand the study protocol and
 provide voluntary, written informed consent, and participate in the outcome measurements. A
 negative or false-positive response to controlled comparative local anesthetic blocks,
 uncontrollable to heavy opioid use (morphine equivalent of 300 mg), uncontrolled
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 neck 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