Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Radiofrequency Ablation

Recruiting in Palo Alto (17 mi)

Overseen byShane Hoeber, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Alberta

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The sacroiliac joint (SIJ) is estimated to be the source of low mechanical back pain in 10-27% of patients. When conservative measures for treating SIJ pain fail (physiotherapy, exercise, analgesic medications, chiropractic manipulation, etc.) radiofrequency ablation (RFA) is a treatment option in carefully selected patients. RFA uses a radiofrequency generator to create a thermal lesion, with the aim of ablating the nerves that innervate the SIJ complex. Studies have confirmed that SIJ RFA can provide significant relief for patients with SIJ pain. The current gold standard is the use of fluoroscopic (x-ray guidance) to visualize bony landmarks in order to create an accurate thermal lesion along the lateral sacral crest; where the nerves that innervate the SIJ complex reside. Recent literature has proposed a technique for an ultrasound-guided approach to achieve an RFA lesion in patients with SIJ pain. It is proposed that with ultrasound-guidance, versus fluoroscopic-guidance, the interventionalist is able to perform fewer needle passes for the procedure, as well as fewer thermal lesions, thereby achieving shorter performance times. The proposed study serves as a non-inferiority randomized controlled trial to assess the effectiveness of ultrasound-guided versus fluoroscopy-guided RFA for the treatment of SIJ pain.

Eligibility Criteria

Inclusion Criteria

Age ≥ 18

Body Mass Index (BMI) ≤35

Clinical presentation must be in keeping with SIJ pain based on both history (pain below L5 vertebrae, localized to the SIJ area, back pain greater than leg pain) and/or physical examination (≥2/5 SIJ provocative tests).

+1 more

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Ultrasound-Guided SIJ RFAExperimental Treatment1 Intervention

Utilizing short axis views, the S1, S2 and S3 foramen and tubercles would be localized and marked by a surgical skin marker. Then, the ultrasound transducer will be moved laterally to achieve a long axis view between the S1 and S2 tubercle. Local skin and subcutaneous tissue freezing would be performed with Lidocaine 1% utilizing a 30-gauge needle. An 18-gauge radiofrequency (RF) cannula will be directed utilizing an in-plane approach toward the S2 and S3 lateral branches between the S2 and S3 tubercles. A small amount of 1% lidocaine will be injected in order to provide comfort. The RF generator will be set to continuous monopolar RF ablation and the needle will be heated to 80 degrees Celsius for 90 seconds. The needle will then be repositioned proximally to obtain a slightly larger burn in a similar fashion previously described. A similar approach will be utilized for the S1 lateral branch RF ablation between the S1 and S2 tubercles.

Group II: Fluoroscopic-Guided SIJ RFAActive Control1 Intervention

An anterior-posterior approach is used to identify the S1-S3 foramen. A 3-inch spinal needle would be used for marking. Local tissue freezing would be accomplished with Lidocaine 1% and a 30-G needle. An 18-G RF cannula will be positioned over the 12 o'clock position of the S1 foramen and a second cannula placed in the 2 o'clock or 10 o'clock position for the right and left respectively (4-5 mm distance between the cannula). A small amount of 1% lidocaine will be injected for comfort. A lateral projection is taken to ensure the needles are not placed into the foramen. The RF generator will be set to continuous bipolar RF ablation and heated to 80 degrees Celsius for 90 seconds. Then another 18-G RF cannula will be positioned at the 4 o'clock or 8 o'clock position (4-5 mm distance between the cannula) to achieve the second RF ablation. The third RF ablation will be performed with the RF cannula at the 6 o'clock position. An identical fashion is utilized at the S2 and S3 foramen.