Ultrasound-guided Sacroiliac Joint Radiofrequency Ablation: A Pilot Study

NCT02335190 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-05-01

No results posted yet for this study

Summary

The sacroiliac (SI) joint is a common source of low back pain. Radiofrequency ablation (RFA) can be used to treat low back pain from the SI joint , and is often recommended by physicians to provide long lasting pain relief. However, the use of RFA for SI joint pain has not been as successful as RFA for pain in other areas of the back and neck. X-ray guidance (fluoroscopy) is currently used to perform this procedure. Under fluoroscopy, however, it can be difficult for physicians to identify necessary landmarks, and there are risks to the patient because of radiation exposure. In contrast, ultrasound may provide better image guidance than fluoroscopy, and there is no radiation risk. The purpose of this study is to examine if ultrasound guided SI joint RFA is effective.

Conditions

  • Sprain of Sacroiliac Ligament
  • Low Back Pain
  • Osteoarthritis Nos, of Sacroiliac Joint

Interventions

PROCEDURE

Radiofrequency ablation

RF ablation will be performed using 2 Nimbus multitined electrodes in a bipolar configuration. The electrodes will be placed along the lateral crest using a leap-frogging technique from the inferomedial aspect of the PSIS to the third transverse sacral tubercle at 1.5-2 cm intervals at the skin surface. A radiofrequency current will be passed for 120 seconds per site resulting in thermal coagulation of the plexus. Prior to performing the thermal lesion, electrical stimulation at 2 Hz and 2.0 V will be administered.

PROCEDURE

Sensory block

Participants will undergo a lidocaine block of the PSN at the lateral crest under ultrasound guidance. 0.5 mL of 2% lidocaine will be injected from the inferomedial border of the PSIS to the third transverse sacral tubercle at approximately 1.5 cm intervals along the skin surface.

DRUG

Lidocaine

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER
  • University of Alberta

    collaborator OTHER
  • Western University, Canada

    lead OTHER

Principal Investigators

  • Eldon Loh, MD · Western University

  • Robert S Burnham, MD, M.Sc. · University of Alberta

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02335190 on ClinicalTrials.gov