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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Baylis Medical Company
ClinicalTrials.gov Identifier:
NCT01158092
First received: July 6, 2010
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

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 Intervention
Chronic Sacroiliac Joint Pain
Device: Treatment with SInergy™ System
Other: Conservative Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Baylis Medical Company:

Primary Outcome Measures:
  • Pain status change for sacroiliac region pain intensity assessed using visual analogue scale (VAS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in bodily pain evaluated using SF-36 Bodily Pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in physical functioning evaluated using SF-36 Physical Function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in disability evaluated using Oswestry Disability Index 2.0 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in quality of life using the Assessment of Quality of Life (AQOL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: July 2010
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158092

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

No publications provided

Responsible Party: Baylis Medical Company
ClinicalTrials.gov Identifier: NCT01158092     History of Changes
Other Study ID Numbers: BMC-SI-CIP-002
Study First Received: July 6, 2010
Last Updated: May 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014