Radiofrequency in Sacroiliac Arthropathy;Bipolar RF 6 Points Versus Monopolar RF at 6 and 3 Points (RFSIBIMONO6)

August 31, 2016 updated by: King Hamad University Hospital, Bahrain

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

Expecting using bipolar RF at six points, in spite of potentially consuming more intraoperative time, to be more effective and long lasting in the management of pain resultant from chronic sacroiliac joint arthropathy than the other 2 techniques using the monopolar RF even if using six points.

Study Overview

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

Interventional

Enrollment (Actual)

60

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

    • Manama
      • Muharraq, Manama, Bahrain
        • King Hamad University Hospital

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

No

Genders Eligible for Study

All

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

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: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: mohamed hashim, SR anesthesia

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

September 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

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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