| December 4, 2008 |
| December 4, 2008 |
| June 2008 |
| Pain status change for sacroiliac joint pai intensity assessed using visual analogue scale [ Time Frame: 12 months ] [ Designated as safety issue: No ] |
| Same as current |
| No Changes Posted |
- change in general health status or physical functioning evaluated usinf SF-6 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change in disability evaluated using Oswestry Disability Index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Quality of Life questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Health Care utilization questionnaire evaluates use or need for other health care, change in opioid use, global perceived effect, return to work, return of pain date [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System |
| A Double Blind, Randomized, Controlled Trial Assessing Cooled Radiofrequency Denervation as a Treatment fr Sacroiliac Joint Pain Using the Sinergy System |
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 |
| |
| |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Sacroiliac Pain |
- Device: Sinergy
- Device: Placebo sham
|
- Active Comparator: Treatment with Sinergy system
- Placebo Comparator: placebo controlled
|
| |
| |
| Recruiting |
| 51 |
| June 2010 |
| June 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| Yes |
|
|
| United States |
|
| |
| NCT00802997 |
| Nileshkumar Patel, Coastal Orthopedics & Sports Medicine |
| SInergy |
| Coastal Orthopedics & Sports Medicine |
|
| Principal Investigator: |
Nileshkumar Patel, MD |
Coastal Orthopedics & Sports Medicine |
|
|
| Coastal Orthopedics & Sports Medicine |
| December 2008 |
