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Sponsored by: |
Pain Management Center of Paducah |
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Information provided by: | Pain Management Center of Paducah |
ClinicalTrials.gov Identifier: | NCT00355706 |
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.
Condition | Intervention |
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Low Back Pain |
Procedure: Thoracic facet joint nerve blocks |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Effectiveness of Thoracic Facet Joint Nerve Blocks: A Randomized, Prospective, Double-Blind Controlled Evaluation |
Estimated Enrollment: | 200 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | July 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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 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.
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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
Contact: Laxmaiah Manchikanti, MD | 270-554-8373 ext 111 | drm@thepainmd.com |
United States, Kentucky | |
Ambulatory Surgery Center | Recruiting |
Paducah, Kentucky, United States, 42003 |
Principal Investigator: | Laxmaiah Manchikanti, MD | Ambulatory Surgery Center |
Study ID Numbers: | protocol 5 |
Study First Received: | July 24, 2006 |
Last Updated: | July 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00355706 |
Health Authority: | United States: Institutional Review Board |
chronic low back pain thoracic facet joint nerve block |
Signs and Symptoms Neurologic Manifestations Low Back Pain Pain Back Pain |
Nervous System Diseases |