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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baylis Medical Company
ClinicalTrials.gov Identifier:
NCT00802997
First received: December 4, 2008
Last updated: November 8, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Baylis Medical Company
ClinicalTrials.gov Identifier: NCT00802997     History of Changes
Other Study ID Numbers: SInergy
Study First Received: December 4, 2008
Results First Received: August 2, 2013
Last Updated: November 8, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 27, 2014