Ultrasound-guided Sacroiliac Joint Radiofrequency Ablation: A Pilot Study
Ultrasound-guided Sacroiliac Joint Radiofrequency Ablation: A Pilot Study
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.
Background:

 This study will examine the effectiveness of sacroiliac joint (SIJ) diagnostic sensory blocks
 and radiofrequency ablation (RFA) under ultrasound guidance. The sacroiliac joint (SIJ) is
 estimated to be the source of pain in 10-27% of patients suffering from mechanical low back
 pain. When pain is refractory to conventional treatments (such as activity modification,
 exercise, physical therapy, chiropractic, anti-inflammatory and analgesic medications and
 corticosteroid injections), radiofrequency ablation (RFA) is a treatment option in carefully
 selected individuals.

 Current practice is to perform the SIJ posterior sensory blocks and RFA under fluoroscopic
 guidance. Research has confirmed that SIJ RFA can provide significant relief, however, the
 success rate and magnitude of relief are variable. Part of this variability may relate to the
 challenging nature of identifying key anatomical landmarks under fluoroscopy - their location
 may not be clearly evident with fluoroscopy particularly if the patient is obese, has low
 bone mineral density or has abundant bowel gas and/or stool in the pelvis.

 A recent cadaveric study by our research group has clarified the sensory innervation of the
 SIJ and the findings have implications for currently practiced SIJ sensory block and RFA
 procedures. The study confirmed that the posterior sacral network innervates the SIJ and runs
 along the lateral crest of the sacrum between the S1 and the S3 lateral sacral tubercles.
 Inasmuch as the lateral sacral crest is predictably and clearly visible on ultrasound,
 posterior sacral network (PSN) SIJ sensory blocks and RFA under ultrasound guidance may be
 feasible using the lateral sacral crest as the key anatomical structure.

 No clinical studies have been done that use ultrasound guidance for SIJ RFA. There are
 numerous advantages to ultrasound-guided SIJ sensory block and RFA. Significantly, patients
 would no longer be exposed to ionizing radiation for their SIJ procedures. With an improved
 understanding of SIJ sensory innevation and technical improvements in RFA electrodes, we
 hypothesize that ultrasound guided SIJ diagnostic sensory blocks and RFA will lead to
 clinically significant outcomes that will be at least comparable to conventional
 fluoroscopic-guided techniques.

 Objectives:

 1. To evaluate the relative effectiveness of ultrasound-guided PSN sacroiliac joint sensory
 block compared to fluoroscopic-guided lateral branch sacroiliac joint block.

 2. To evaluate the relative effectiveness of ultrasound-guided PSN sacroiliac joint
 radiofrequency ablation compared to fluoroscopic-guided lateral branch sacroiliac joint
 RFA.

 Methodology:

 This study is a prospective cohort study examining the effectiveness of ultrasound-guided SIJ
 sensory block and RFA of the PSN, compared to fluoroscopic guided SIJ RFA. Participants will
 first undergo a local anesthetic block under ultrasound guidance to determine the predictive
 value of this test for SIJ RFA; they will then undergo the SIJ RFA procedure. For some
 patients in this study, this will be a repeat RFA procedure as they would have had a previous
 fluoroscopic-guided SIJ RFA with success, but subsequent return of their pain.

 SIJ Sensory Block: Eligible study subjects will initially undergo a lidocaine block of the
 PSN at the lateral crest under ultrasound guidance. Their index pain intensity prior to the
 block must be >2/10. 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. Following the local anesthetic block, the subject
 will be asked to complete a pain diary for 6 hours. Specifically, their baseline pain will be
 reassessed and their ability to perform functional activities will also be assessed over that
 time period. The results of this block will be compared to the results of conventional blocks
 done under fluoroscopy.

 SIJ RFA: Ultrasound-guided RFA of the PSN will be performed using the same technique as the
 local anesthetic block with the exception that 2 Nimbus multitined electrodes will be used in
 a bipolar configuration. The electrodes will be placed along the lateral crest using a
 sequential, leap-frogging technique from the inferomedial aspect of the PSIS (at or just
 above the level of the S1 dorsal sacral foramen if visible, or the S1 spinous process if not)
 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 thus raising the temperature
 at the dorsal periosteum and adjacent soft tissue to 80°C 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. If the patient perceives, or the operator observes muscle contraction
 of the leg or anal sphincter, no radiofrequency current will be applied and the needle tip
 will be adjusted to a position away from where the sacral nerve roots may lie.

 Analysis:

 The effectiveness of ultrasound-guided sensory blocks and RFA will be directly compared to
 the effectiveness of fluoroscopic-guided sensory blocks and RFA. In patients who have had the
 SIJ RFA procedure previously, their current ultrasound-guided PDQQ-S scores will be compared
 to their previous fluoroscopic-guided PDQQ-S results. In patients who are receiving the SIJ
 RFA procedure for the first time, a database of SIJ RFA PDQQ-S scores of patients treated
 over the past 5 years with the fluoroscopic-guided RFA technique is available for comparison.
 Their results will be compared to age and pre-RFA matched patients from the database.
Inclusion Criteria:

 -  18 years of age or older

 -  Clinical presentation compatible with SI joint origin pain (back pain below L5;
 localized to the SI joint area; >2 positive of 5 SI joint provocative tests).

 -  >50% index pain relief with at least one SIJ intra-articular local anesthetic block
 and at least one SIJ lateral branch block using the conventional fluoroscopically
 guided lateral branch block technique. Pain diary records for these interventions need
 to be on file.

 Exclusion Criteria:

 -  Under 18 years of age

 -  Presence of clinical and investigative evidence of inflammatory spondyloarthropathy,
 fibromyalgia, radiculopathy, symptomatic spinal stenosis, facetogenic or discogenic
 low back pain, generalized infection, localized infection in the area of the low
 back/SIJs, coagulopathy or anticoagulation, allergy to local anesthetic