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Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00802997
First Posted: December 5, 2008
Last Update Posted: January 1, 2014
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
  Purpose
to evaluate the effectiveness of cooled radiotherapy denervation of the sacroiliac region using the sinergy system by comparing a treatment group to a placebo group

Condition Intervention
Other Acute Pain Chronic Pain Device: Sinergy Device: Placebo sham

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Controlled Trial Assessing Cooled Radiofrequency Denervation as a Treatment fr Sacroiliac Joint Pain Using the Sinergy System

Further study details as provided by Baylis Medical Company:

Primary Outcome Measures:
  • Pain Status Change for Sacroiliac Joint Pain Intensity [ Time Frame: Baseline and 3 months ]
    Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.


Other Outcome Measures:
  • Pain Status Change for Sacroiliac Joint Pain Intensity [ Time Frame: Baseline and 6 Months ]
    Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.

  • Pain Status Change for Sacroiliac Joint Pain Intensity [ Time Frame: Baseline and 9 Months ]
    Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.


Enrollment: 51
Study Start Date: June 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Treatment with Sinergy system
Device: Sinergy
radiofrequency denervation
Placebo Comparator: 2
placebo controlled
Device: Placebo sham
sham procedure

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Predominantly axial pain below L5 vertebrae
  • greater than 75%pain relief from 2 seperate lateral branch blocks done on different days
  • chronic axial pain lasting longer than 6 months, 3 day average VAS between 4 and 8
  • age greater than 18
  • failed to acheive adequate improvemnet with comprehensive non-operative treatments, includingbut not limited to: activity alteration, non0steriodal anti-iflammatory, physical and/or manual therap, and flurpscopically guided steriod injections in and around the area of pathology
  • all other possible sources oflow back pain have been ruled out, including but not limited to the intervertebral discs, bone fracture.

Exclusion Criteria:

  • Beck Depression greater than 20%
  • irreversible psychological barriers to recovery
  • spinal pathology that may impede recovery such as spins bifida occulta,
  • moderate to severe foraminal or central canal stenosis
  • systemic infection or localized infection at inducer site
  • concomitant cervical or thoracic pain greater than 2/10 on VAS
  • uncontrolled or acute disease
  • chronic severe condition such as rheumatoid arthritis
  • preganancy
  • active radicular pain
  • immunosuppression
  • workers compensation
  • allergy to injectants or medications used in procedure
  • high narcotis use greater than 30 mg hydrocodone or equivalent
  • smokers
  • body mass index greater than 29.9
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00802997


Locations
United States, Florida
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, United States, 34209
Sponsors and Collaborators
Baylis Medical Company
Investigators
Principal Investigator: Nileshkumar Patel, MD Coastal Orthopedics & Sports Medicine
  More Information

Responsible Party: Baylis Medical Company
ClinicalTrials.gov Identifier: NCT00802997     History of Changes
Other Study ID Numbers: SInergy
First Submitted: December 4, 2008
First Posted: December 5, 2008
Results First Submitted: August 2, 2013
Results First Posted: January 1, 2014
Last Update Posted: January 1, 2014
Last Verified: November 2013

Additional relevant MeSH terms:
Chronic Pain
Acute Pain
Arthralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases