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

Baylis Medical

Status: Completed

Conditions: Other Acute Pain; Chronic Pain

Treatments: Device: Sinergy; Device: Placebo sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT00802997

SInergy

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Treatment with Sinergy system

Treatment:

Device: Sinergy

2

Placebo Comparator group

Description:

placebo controlled

Treatment:

Device: Placebo sham