Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System

Not Applicable

Completed

• Conditions: Other Acute Pain; Chronic Pain
• Interventions: Device: Sinergy; Device: Placebo sham

• Registration Number: NCT00802997
• Lead Sponsor: Baylis Medical Company

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-12-04
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2013-08-02
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-08
• Last Update Submitted: 2013-11-08
• Results First Posted: 2014-01-01
• Last Update Posted: 2014-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Sinergy	Treatment with Sinergy system
2	Placebo sham	placebo controlled

Primary Outcome Measures

Name	Time	Method
Pain Status Change for Sacroiliac Joint Pain Intensity	Baseline and 3 months	Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.

Trial Locations

Locations (1)

Coastal Orthopedics & Sports Medicine; 🇺🇸 Bradenton, Florida, United States