Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System
NCT ID: NCT00802997
Last Updated: 2014-01-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2008-06-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Treatment with Sinergy system
Sinergy
radiofrequency denervation
2
placebo controlled
Placebo sham
sham procedure
Interventions
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Sinergy
radiofrequency denervation
Placebo sham
sham procedure
Eligibility Criteria
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Inclusion Criteria
* greater than 75%pain relief from 2 seperate lateral branch blocks done on different days
* chronic axial pain lasting longer than 6 months, 3 day average VAS between 4 and 8
* age greater than 18
* failed to acheive adequate improvemnet with comprehensive non-operative treatments, includingbut not limited to: activity alteration, non0steriodal anti-iflammatory, physical and/or manual therap, and flurpscopically guided steriod injections in and around the area of pathology
* all other possible sources oflow back pain have been ruled out, including but not limited to the intervertebral discs, bone fracture.
Exclusion Criteria
* irreversible psychological barriers to recovery
* spinal pathology that may impede recovery such as spins bifida occulta,
* moderate to severe foraminal or central canal stenosis
* systemic infection or localized infection at inducer site
* concomitant cervical or thoracic pain greater than 2/10 on VAS
* uncontrolled or acute disease
* chronic severe condition such as rheumatoid arthritis
* preganancy
* active radicular pain
* immunosuppression
* workers compensation
* allergy to injectants or medications used in procedure
* high narcotis use greater than 30 mg hydrocodone or equivalent
* smokers
* body mass index greater than 29.9
18 Years
ALL
Yes
Sponsors
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Baylis Medical Company
INDUSTRY
Responsible Party
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Principal Investigators
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Nileshkumar Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Coastal Orthopedics & Sports Medicine
Locations
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Coastal Orthopedics & Sports Medicine
Bradenton, Florida, United States
Countries
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Other Identifiers
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SInergy
Identifier Type: -
Identifier Source: org_study_id
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