search
Back to results

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

Primary Purpose

Other Acute Pain, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sinergy
Placebo sham
Sponsored by
Baylis Medical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Other Acute Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Coastal Orthopedics & Sports Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Treatment with Sinergy system

placebo controlled

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 4, 2008
Last Updated
November 8, 2013
Sponsor
Baylis Medical Company
search

1. Study Identification

Unique Protocol Identification Number
NCT00802997
Brief Title
Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System
Official Title
A Double Blind, Randomized, Controlled Trial Assessing Cooled Radiofrequency Denervation as a Treatment fr Sacroiliac Joint Pain Using the Sinergy System
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylis Medical Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Acute Pain, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Treatment with Sinergy system
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo controlled
Intervention Type
Device
Intervention Name(s)
Sinergy
Intervention Description
radiofrequency denervation
Intervention Type
Device
Intervention Name(s)
Placebo sham
Intervention Description
sham procedure
Primary Outcome Measure Information:
Title
Pain Status Change for Sacroiliac Joint Pain Intensity
Description
Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.
Time Frame
Baseline and 3 months
Other Pre-specified Outcome Measures:
Title
Pain Status Change for Sacroiliac Joint Pain Intensity
Description
Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.
Time Frame
Baseline and 6 Months
Title
Pain Status Change for Sacroiliac Joint Pain Intensity
Description
Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.
Time Frame
Baseline and 9 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nileshkumar Patel, MD
Organizational Affiliation
Coastal Orthopedics & Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coastal Orthopedics & Sports Medicine
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs