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Sponsored by: |
Coastal Orthopedics & Sports Medicine |
---|---|
Information provided by: | Coastal Orthopedics & Sports Medicine |
ClinicalTrials.gov Identifier: | NCT00802997 |
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
Condition | Intervention |
---|---|
Sacroiliac Pain |
Device: Sinergy Device: Placebo sham |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double Blind, Randomized, Controlled Trial Assessing Cooled Radiofrequency Denervation as a Treatment fr Sacroiliac Joint Pain Using the Sinergy System |
Estimated Enrollment: | 51 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Treatment with Sinergy system
|
Device: Sinergy
radiofrequency denervation
|
2: Placebo Comparator
placebo controlled
|
Device: Placebo sham
sham procedure
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Denise l Dorman, RN | 9417821353 | ddorman@coastalorhtopedics.com |
Contact: Andrea h Mehalko | 9417921404 ext 1124 | amehalko@coastalorthopedics.com |
United States, Florida | |
Coastal Orthopedics & Sports Medicine | Recruiting |
Bradenton, Florida, United States, 34209 | |
Contact: Denise l Dorman, RN 941-782-1353 ddorman@coastalorthopedics.com | |
Contact: Andrea h mehalko 9417921404 ext 1124 amehalko@coastalorthopedics.com |
Principal Investigator: | Nileshkumar Patel, MD | Coastal Orthopedics & Sports Medicine |
Responsible Party: | Coastal Orthopedics & Sports Medicine ( Nileshkumar Patel ) |
Study ID Numbers: | SInergy |
Study First Received: | December 4, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00802997 History of Changes |
Health Authority: | United States: Institutional Review Board |
Pain Arthralgia |