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

Primary Purpose

Radiofrequency Ablation, Chronic Sacroiliac Joint Arthropathy

Status
Completed
Phase
Not Applicable
Locations
Bahrain
Study Type
Interventional
Intervention
radiofrequency ablation for sacroiliac joint arthropathy
Sponsored by
King Hamad University Hospital, Bahrain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiofrequency Ablation focused on measuring Radiofrequency, monopolar, bipolar, Sacroiliac Joint Arthropathy, three different modalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • King Hamad University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

bipolar RF 6 points

monopolar RF 6 points

monopolar RF 3 points

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

patient satisfaction
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.

Secondary Outcome Measures

Full Information

First Posted
March 3, 2015
Last Updated
August 31, 2016
Sponsor
King Hamad University Hospital, Bahrain
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1. Study Identification

Unique Protocol Identification Number
NCT02382289
Brief Title
Radiofrequency in Sacroiliac Arthropathy;Bipolar RF 6 Points Versus Monopolar RF at 6 and 3 Points
Acronym
RFSIBIMONO6
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Hamad University Hospital, Bahrain

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiofrequency Ablation, Chronic Sacroiliac Joint Arthropathy
Keywords
Radiofrequency, monopolar, bipolar, Sacroiliac Joint Arthropathy, three different modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bipolar RF 6 points
Arm Type
Active Comparator
Arm Description
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.
Arm Title
monopolar RF 6 points
Arm Type
Active Comparator
Arm Description
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.
Arm Title
monopolar RF 3 points
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation for sacroiliac joint arthropathy
Intervention Description
comparing bipolar RF at 6 points with monopolar RF at 3 and 6 points for the treatment of SI arthropathy
Primary Outcome Measure Information:
Title
patient satisfaction
Description
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.
Time Frame
6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed hashim, SR anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Hamad University Hospital
City
Muharraq
State/Province
Manama
Country
Bahrain

12. IPD Sharing Statement

Learn more about this trial

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

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