Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System
CompletedNot applicableNCT00802997
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- Official title
- A Double Blind, Randomized, Controlled Trial Assessing Cooled Radiofrequency Denervation as a Treatment fr Sacroiliac Joint Pain Using the Sinergy System
- Conditions
- Other Acute Pain
- Chronic Pain
- Interventions
- Device: Sinergy
- Device: Placebo sham
- Sponsor
- Baylis Medical Company
- Start date
- 2008-06
- Primary completion
- 2011-08
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00802997