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

Chronic Pain Clinical Trial

Official title:

A Double Blind, Randomized, Controlled Trial Assessing Cooled Radiofrequency Denervation as a Treatment fr Sacroiliac Joint Pain Using the Sinergy System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802997
• Other study ID #: SInergy
• Status: Completed
• Phase: N/A
• First received: December 4, 2008
• Last updated: November 8, 2013
• Start date: June 2008
• Est. completion date: August 2011

Study information

• Verified date: November 2013
• Source: Baylis Medical Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Other Acute Pain

Intervention

Device:
• Sinergy
radiofrequency denervation
• Placebo sham
sham procedure

Locations

Country	Name	City	State
United States	Coastal Orthopedics & Sports Medicine	Bradenton	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Baylis Medical Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Status Change for Sacroiliac Joint Pain Intensity	Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.	Baseline and 6 Months	No
Other	Pain Status Change for Sacroiliac Joint Pain Intensity	Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.	Baseline and 9 Months	No
Primary	Pain Status Change for Sacroiliac Joint Pain Intensity	Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.	Baseline and 3 months	No