| Descriptive Information Fields | |||||
|---|---|---|---|---|---|
| Brief Title † | Effectiveness of Thoracic Facet Joint Nerve Blocks | ||||
| Official Title † | Effectiveness of Thoracic Facet Joint Nerve Blocks: A Randomized, Prospective, Double-Blind Controlled Evaluation | ||||
| Brief Summary |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | To demonstrate a clinically significant difference between the patients treated with Depo-steroid and those patients randomized to Group I in the pain status, physical, and psychological status and pain at 3, 6, 12, 18 and 24 months post treatment. | ||||
| Secondary Outcome Measure † | To assess adverse events in all patients | ||||
| Condition † | Low Back Pain | ||||
| Intervention † | Procedure: Thoracic facet joint nerve blocks | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 200 | ||||
| Start Date † | August 2003 | ||||
| Completion Date | July 2006 | ||||
| Eligibility Criteria † | 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:
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 |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00355706 | ||||
| Organization ID | protocol 5 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Pain Management Center of Paducah | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Pain Management Center of Paducah | ||||
| Verification Date | July 2006 | ||||
| First Received Date † | July 24, 2006 | ||||
| Last Updated Date | July 24, 2006 | ||||