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

NCT02382289 | Completed DMC

• 1 other identifier: Mour2014/60
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiofrequency Ablation; Chronic Sacroiliac Joint Arthropathy

Keywords

Radiofrequency; monopolar; bipolar; Sacroiliac Joint Arthropathy; three different modalities

Outcome Measures

Primary Outcomes (1)

• 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.

  6-12 months

Study Arms (3)

bipolar RF 6 points

ACTIVE COMPARATOR

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.

Procedure: radiofrequency ablation for sacroiliac joint arthropathy

monopolar RF 6 points

ACTIVE COMPARATOR

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.

Procedure: radiofrequency ablation for sacroiliac joint arthropathy

monopolar RF 3 points

ACTIVE COMPARATOR

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.

Procedure: radiofrequency ablation for sacroiliac joint arthropathy

Interventions

radiofrequency ablation for sacroiliac joint arthropathy PROCEDURE

comparing bipolar RF at 6 points with monopolar RF at 3 and 6 points for the treatment of SI arthropathy

bipolar RF 6 points; monopolar RF 3 points; monopolar RF 6 points

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Hamad University Hospital, Bahrain: lead

Study Sites (1)

King Hamad University Hospital

Muharraq, Manama, Bahrain

Location

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• mohamed hashim, SR anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 6, 2015
• Study Start: September 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

BA (1)