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

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ClinicalTrials.gov Identifier: NCT00802997
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : January 1, 2014
Last Update Posted : January 1, 2014
Sponsor:
Information provided by (Responsible Party):
Baylis Medical Company

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Other Acute Pain Chronic Pain Device: Sinergy Device: Placebo sham Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
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
Study Start Date : June 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Treatment with Sinergy system
 Device: Sinergy
radiofrequency denervation
Placebo Comparator: 2
placebo controlled
 Device: Placebo sham
sham procedure


Outcome Measures
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Primary Outcome Measures :
  1. 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:
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Florida
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, United States, 34209
Sponsors and Collaborators
Baylis Medical Company
Investigators
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Principal Investigator: Nileshkumar Patel, MD Coastal Orthopedics & Sports Medicine
More Information
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Responsible Party: Baylis Medical Company
ClinicalTrials.gov Identifier: NCT00802997    
Other Study ID Numbers: SInergy
First Posted: December 5, 2008    Key Record Dates
Results First Posted: January 1, 2014
Last Update Posted: January 1, 2014
Last Verified: November 2013
Additional relevant MeSH terms:
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Arthralgia
Chronic Pain
Acute Pain
Pain
 Neurologic Manifestations
Joint Diseases
Musculoskeletal Diseases