- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00802997
Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System
November 8, 2013 updated by: Baylis Medical Company
A Double Blind, Randomized, Controlled Trial Assessing Cooled Radiofrequency Denervation as a Treatment fr Sacroiliac Joint Pain Using the Sinergy System
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Bradenton, Florida, United States, 34209
- Coastal Orthopedics & Sports Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Treatment with Sinergy system
|
radiofrequency denervation
|
Placebo Comparator: 2
placebo controlled
|
sham procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Status Change for Sacroiliac Joint Pain Intensity
Time Frame: Baseline and 3 months
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Status Change for Sacroiliac Joint Pain Intensity
Time Frame: Baseline and 6 Months
|
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
|
Pain Status Change for Sacroiliac Joint Pain Intensity
Time Frame: Baseline and 9 Months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nileshkumar Patel, MD, Coastal Orthopedics & Sports Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
December 4, 2008
First Submitted That Met QC Criteria
December 4, 2008
First Posted (Estimate)
December 5, 2008
Study Record Updates
Last Update Posted (Estimate)
January 1, 2014
Last Update Submitted That Met QC Criteria
November 8, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SInergy
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Pain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Vastra Gotaland RegionCompletedPain, Chronic | Widespread Chronic PainSweden
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingChronic Post Operative Pain | Chronic Post-surgical Pain | Chronic Knee PainSpain
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
University of UtahRecruitingChronic Pain | Chronic Pain Syndrome | Widespread Chronic PainUnited States
-
Societa Italiana Anestesia Analgesia Rianimazione...RecruitingPost Operative Pain | Postoperative Pain, Chronic | Post Surgical PainItaly
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
University Health Network, TorontoAcademic Medical Organization of Southwestern Ontario; York University; Toronto...Not yet recruitingPain, Acute | Pain, Chronic | Post-surgical Pain | Post-Surgical Pain, ChronicCanada
-
Evolve Restorative CenterFlowonix Medical; Celéri Health, Inc.; Advanced Infusion SolutionsCompletedPain, Chronic | Pain, Intractable | Chronic Nonmalignant PainUnited States
Clinical Trials on Sinergy
-
Avanos MedicalCompletedSacroiliac Joint PainUnited States
-
Baylis Medical CompanyTerminatedChronic Sacroiliac Joint PainUnited States