Status:
COMPLETED
Effectiveness of Lumbar Facet Joint Nerve Blocks
Lead Sponsor:
Pain Management Center of Paducah
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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 addit...
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 psy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00355914
Start Date
August 1 2003
End Date
July 1 2006
Last Update
November 26 2013
Active Locations (1)
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1
Ambulatory Surgery Center
Paducah, Kentucky, United States, 42003