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

This study is currently recruiting participants.

Verified by Coastal Orthopedics & Sports Medicine, December 2008

First Received: December 4, 2008 No Changes Posted

Sponsored by:	Coastal Orthopedics & Sports Medicine
Information provided by:	Coastal Orthopedics & Sports Medicine
ClinicalTrials.gov Identifier:	NCT00802997

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
Sacroiliac Pain	Device: Sinergy Device: Placebo sham

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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 Coastal Orthopedics & Sports Medicine:

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 usinf SF-6 [ 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 ]

Estimated Enrollment:	51
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Treatment with Sinergy system	Device: Sinergy radiofrequency denervation
2: Placebo Comparator 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

Contacts

Contact: Denise l Dorman, RN	9417821353	ddorman@coastalorhtopedics.com
Contact: Andrea h Mehalko	9417921404 ext 1124	amehalko@coastalorthopedics.com

Locations

United States, Florida
Coastal Orthopedics & Sports Medicine	Recruiting
Bradenton, Florida, United States, 34209
Contact: Denise l Dorman, RN 941-782-1353 ddorman@coastalorthopedics.com
Contact: Andrea h mehalko 9417921404 ext 1124 amehalko@coastalorthopedics.com

Sponsors and Collaborators

Coastal Orthopedics & Sports Medicine

Investigators

Principal Investigator:

Nileshkumar Patel, MD

Coastal Orthopedics & Sports Medicine

More Information

No publications provided

Responsible Party:	Coastal Orthopedics & Sports Medicine ( Nileshkumar Patel )
Study ID Numbers:	SInergy
Study First Received:	December 4, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00802997 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Pain
Arthralgia

ClinicalTrials.gov processed this record on May 07, 2009