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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01158092
First Posted: July 8, 2010
Last Update Posted: May 6, 2013
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.
Information provided by (Responsible Party):
Baylis Medical Company
July 6, 2010
July 8, 2010
May 6, 2013
July 2010
March 2012   (Final data collection date for primary outcome measure)
Pain status change for sacroiliac region pain intensity assessed using visual analogue scale (VAS) [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01158092 on ClinicalTrials.gov Archive Site
  • Change in bodily pain evaluated using SF-36 Bodily Pain [ Time Frame: 12 months ]
  • Change in physical functioning evaluated using SF-36 Physical Function [ Time Frame: 12 months ]
  • Change in disability evaluated using Oswestry Disability Index 2.0 [ Time Frame: 12 months ]
  • Change in quality of life using the Assessment of Quality of Life (AQOL) [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
Trial Comparing Treatment With SInergy™ System to Conservative Treatment for Chronic Sacroiliac Joint Pain
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Sacroiliac Joint Pain
  • Device: Treatment with SInergy™ System
    Lateral branch denervation using the SInergy™ System
  • Other: Conservative Treatment
    Treatment with physical therapy, chiropractic care, and medication
  • Active Comparator: Treatment with SInergy™ System
    Lateral branch denervation using the SInergy™ System
    Intervention: Device: Treatment with SInergy™ System
  • Active Comparator: Conservative Treatment
    Treatment with physical therapy, chiropractic care, and medication
    Intervention: Other: Conservative Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
Not Provided
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01158092
BMC-SI-CIP-002
Not Provided
Not Provided
Not Provided
Baylis Medical Company
Baylis Medical Company
Not Provided
Principal Investigator: Edgar L Ross, M.D. Brigham and Women's Hospital
Baylis Medical Company
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP