Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using … (NCT00802997) | Clinical Trial Compass
CompletedNot Applicable
Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System
United States51 participantsStarted 2008-06
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Pain Status Change for Sacroiliac Joint Pain Intensity