Trial Comparing Treatment With SInergy™ System to Conservative Treatment for Chronic Sacroiliac Joint Pain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of cooled radiofrequency denervation of the sacroiliac region using the SInergy System compared to conservative treatment in the treatment of sacroiliac joint pain.

Official Title
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A Randomized Controlled Trial Comparing Cooled Radiofrequency Denervation to Conservative Treatment as a Treatment for Sacroiliac Joint Pain Using the SInergy™ System

Conditions
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Chronic Sacroiliac Joint Pain

Intervention / Treatment
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* Device: Treatment with SInergy™ System
* Other: Conservative Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Predominantly axial pain below the L5 vertebrae >75% pain relief from 2 separate lateral branch blocks done on different days (followed by return to baseline pain) Chronic axial pain lasting for longer than six months: 3 day average VAS between 4 and 8. Age greater than 18 years. Failed to achieve adequate improvement with comprehensive non-operative treatments, including but not limited to: activity alteration, non-steroidal anti-inflammatory, physical and/or manual therapy, and fluoroscopically guided steroid injections in and around the area of pathology. All other possible sources of low back pain have been ruled out, including but not limited to: the intervertebral discs, bone fracture, the zygapophyseal joints, the hip joint, symptomatic spondylolisthesis, tumor and other regional soft tissue structures (this is done by physical exam, medical history, and MRI/CT/X-ray as required) Exclusion Criteria: Beck Depression Score >20 or irreversible psychological barriers to recovery Spinal pathology that may impede recovery such as spina bifida occulta, spondylolisthesis at L5/S1, or scoliosis. Moderate or severe foraminal or central canal stenosis Systemic infection or localized infection at anticipated introducer entry site. Concomitant cervical or thoracic pain greater than 2/10 on a VAS Uncontrolled or acute illness Chronic severe conditions such as rheumatoid/inflammatory arthritis Pregnancy Active radicular pain Immunosuppression (eg. AIDS, cancer, diabetes, surgery <3 months ago) Worker's compensation, injury litigation, or disability remuneration Allergy to injectants or medications used in procedure High narcotics use (>30 mg hydrocodone or equivalent) Patients who smoke. Termination for at least 6 months and no smoking during follow up period are acceptable with caution. Body Mass Index greater than 29.9 (obese). Subject unwilling to consent to the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment with SInergy™ System<br>Lateral branch denervation using the SInergy™ System | Device: Treatment with SInergy™ System<br>* Lateral branch denervation using the SInergy™ System<br>|
| Active Comparator: Conservative Treatment<br>Treatment with physical therapy, chiropractic care, and medication | Other: Conservative Treatment<br>* Treatment with physical therapy, chiropractic care, and medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain status change for sacroiliac region pain intensity assessed using visual analogue scale (VAS) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bodily pain evaluated using SF-36 Bodily Pain |  | 12 months | 
| Change in physical functioning evaluated using SF-36 Physical Function |  | 12 months | 
| Change in disability evaluated using Oswestry Disability Index 2.0 |  | 12 months | 
| Change in quality of life using the Assessment of Quality of Life (AQOL) |  | 12 months |