N/A
N=51
Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System
Other Acute Pain · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT00802997 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Pain Status Change for Sacroiliac Joint Pain Intensity — -2.4; -0.8 units on a scale — p=0.035
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sinergy (Device); Placebo sham (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baylis Medical Company
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Status Change for Sacroiliac Joint Pain Intensity |
-2.7 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00802997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.