- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02382289
Radiofrequency in Sacroiliac Arthropathy;Bipolar RF 6 Points Versus Monopolar RF at 6 and 3 Points (RFSIBIMONO6)
Radiofrequency Ablation for the Treatment of Chronic Sacroiliac Joint Arthropathy; Comparing the Use of Bipolar RF at Six Points Versus Monopolar RF at Six Points and Three Points
Study Overview
Status
Intervention / Treatment
Detailed Description
A Prospective, single center, double blind, controlled randomized trial.
Sample Size:
Total of 60 patients divided into three groups:
Group 1: 20 patients will be receiving bipolar RF at six points. Group 2: 20 patients will be receiving monopolar RF at six points. Group 3: 20 patients will be receiving monopolar RF at three points.
Sampling technique:
Patients will be randomly divided in three groups. There will be a box with 60 closed envelopes, divided randomly in to three groups with 20 envelops in each group. On arrival to theatre one of the envelops will be opened and the assigned method will be applied.
Timeframe of the study:
6-12 months
Procedure:
After fulfilling inclusion criteria and apart from the exclusion criteria, patients will do either one of the three procedures according to the randomization. All patients will do the procedure under fluoroscopic guidance with use of Cosman RF generator G4TM, 20 gauge straight sharp cannula, 10 cm shaft, 10 mm tip and 10 cm electrodes (Cosman autoclavable CSK-TC10).
Group 1 ; Six RF needles will be put between the SIJ and the lateral aspects of the ipsilateral dorsal sacral foramina. After sensory and motor stimulation, bipolar lesion RF at 80oc for 90 sec will be applied between each successive pairs of needles.
Group 2; RF needle is inserted at six levels in the area between the SIJ and the lateral aspects of the ipsilateral dorsal sacral foramina. after sensory and motor stimulation, monopolar lesion RF at 80oc for 90 sec will be applied.
Group 3; RF needle is inserted at six levels in the upper , middle and lower part of the area between the SIJ and the lateral aspects of the ipsilateral dorsal sacral foramina. after sensory and motor stimulation, monopolar lesion RF at 80oc for 90 sec will be applied.
Patients will be evaluated by a specialized pain nurse after 2 weeks, one month, 3 months and 6 months for pain score using the visual analogue pain scale.
Overall patient satisfaction with pain relief will be evaluated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Manama
-
Muharraq, Manama, Bahrain
- King Hamad University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Moderate to severe low back pain for more than six months with positive Patrick's and Yeoman's tests with tenderness over the SI joint.
- Pain is not responding to the usual medical treatment.
- More than 50 % pain relief after diagnostic injection with local anesthetic.
Exclusion Criteria:
• Patient refusal to do the procedure or to share in the study
- Focal Neurologic Signs.
- significant anticoagulation e.g. clopedogril (low dose aspirin will be excluded)
- Pregnancy, breast feeding or planning on becoming pregnant during the trial.
- Infection at the intended injection site.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: bipolar RF 6 points
Six RF needles will be put between the SIJ and the lateral aspects of the ipsilateral dorsal sacral foramina.
After sensory and motor stimulation, bipolar lesion RF at 80oc for 90 sec will be applied between each successive pairs of needles.
|
comparing bipolar RF at 6 points with monopolar RF at 3 and 6 points for the treatment of SI arthropathy
|
Active Comparator: monopolar RF 6 points
RF needle is inserted at six levels in the area between the SIJ and the lateral aspects of the ipsilateral dorsal sacral foramina.
after sensory and motor stimulation, monopolar lesion RF at 80oc for 90 sec will be applied.
|
comparing bipolar RF at 6 points with monopolar RF at 3 and 6 points for the treatment of SI arthropathy
|
Active Comparator: monopolar RF 3 points
RF needle is inserted at three levels in the upper , middle and lower part of the area between the SIJ and the lateral aspects of the ipsilateral dorsal sacral foramina.
after sensory and motor stimulation, monopolar lesion RF at 80oc for 90 sec will be applied.
|
comparing bipolar RF at 6 points with monopolar RF at 3 and 6 points for the treatment of SI arthropathy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient satisfaction
Time Frame: 6-12 months
|
Patients suffering chronic low back pain due to sacroiliac joint arthropathy will receive a potentially more effective method of radiofrequency ablation with an overall better patient satisfaction.
|
6-12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: mohamed hashim, SR anesthesia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mour2014/60
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.
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