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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01158092
Recruitment Status : Terminated
First Posted : July 8, 2010
Last Update Posted : May 6, 2013
Information provided by (Responsible Party):
Baylis Medical Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Sacroiliac Joint Pain Device: Treatment with SInergy™ System Other: Conservative Treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Cooled Radiofrequency Denervation to Conservative Treatment as a Treatment for Sacroiliac Joint Pain Using the SInergy™ System
Study Start Date : July 2010
Actual Primary Completion Date : March 2012

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

Primary Outcome Measures :
  1. Pain status change for sacroiliac region pain intensity assessed using visual analogue scale (VAS) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change in bodily pain evaluated using SF-36 Bodily Pain [ Time Frame: 12 months ]
  2. Change in physical functioning evaluated using SF-36 Physical Function [ Time Frame: 12 months ]
  3. Change in disability evaluated using Oswestry Disability Index 2.0 [ Time Frame: 12 months ]
  4. Change in quality of life using the Assessment of Quality of Life (AQOL) [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01158092

United States, Massachusetts
Brigham and Women's Hospital Pain Trials Center
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Baylis Medical Company
Principal Investigator: Edgar L Ross, M.D. Brigham and Women's Hospital

Responsible Party: Baylis Medical Company Identifier: NCT01158092     History of Changes
Other Study ID Numbers: BMC-SI-CIP-002
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: May 6, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms