Status:
COMPLETED
Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System
Lead Sponsor:
Baylis Medical Company
Conditions:
Other Acute Pain
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
to evaluate the effectiveness of cooled radiotherapy denervation of the sacroiliac region using the sinergy system by comparing a treatment group to a placebo group
Eligibility Criteria
Inclusion
- Predominantly axial pain below L5 vertebrae
- 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
- Beck Depression greater than 20%
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00802997
Start Date
June 1 2008
End Date
August 1 2011
Last Update
January 1 2014
Active Locations (1)
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1
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, United States, 34209