Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System
Completed · Not applicable · Has a placebo group
Conditions studied: Other Acute Pain, Chronic Pain
In brief
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
Key facts
- Study ID
- NCT00802997
- Run by
- Baylis Medical Company
- People needed
- 51
- Starts
- 2008-06-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2014-01-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Coastal Orthopedics & Sports Medicine — Bradenton, Florida, United States
- Coastal Orthopedics & Sports Medicine — Bradenton, Florida, United States
Full record on ClinicalTrials.gov
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