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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:
Information provided by (Responsible Party):
Baylis Medical Company
ClinicalTrials.gov Identifier:
NCT00802997
First received: December 4, 2008
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  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:

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Further study details as provided by Baylis Medical Company:

Primary Outcome Measures:
  • Pain status change for sacroiliac joint pai intensity assessed using visual analogue scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in general health status or physical functioning evaluated using SF-36 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in disability evaluated using Oswestry Disability Index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of Life questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Health Care utilization questionnaire evaluates use or need for other health care, change in opioid use, global perceived effect, return to work, return of pain date [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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
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
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013