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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Status Change for Sacroiliac Joint Pain Intensity