Trial Comparing Treatment With SInergy™ System to Conservative Treatment for Chronic Sacroiliac Joint Pain (SI-RCT-Ross)

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Sacroiliac Joint Pain
• Intervention / Treatment: Device: Treatment with SInergy™ System; Other: Conservative Treatment

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Brigham and Women's Hospital Pain Trials Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Baylis Medical Company
• Investigators: Principal Investigator: Edgar L Ross, M.D., Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: July 6, 2010
• First Submitted That Met QC Criteria: July 7, 2010
• First Posted (Estimate): July 8, 2010

Study Record Updates

• Last Update Posted (Estimate): May 6, 2013
• Last Update Submitted That Met QC Criteria: May 3, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia
• Other Study ID Numbers: BMC-SI-CIP-002