Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Radiofrequency Ablation

NCT04534829 | Withdrawn Phase 3

• 1 other identifier: Pro00102343
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sacroiliac Joint Somatic Dysfunction

Keywords

Radiofrequency Ablation; Fluoroscopy; Ultrasound; Sacroiliac joint

Outcome Measures

Primary Outcomes (2)

• Pain reduction: change from baseline pain scores

  Visual analog scale (VAS) for pain at the various follow-up time periods. The visual analog scale is a numerical scale from 0 to 10; with 0 representing no pain and 10 representing the worst pain imaginable.

  6 weeks to 18 months post-procedure.

• Function and quality of life

  Pain, Disability and Quality of Life Questionnaire- Spine (PDQQ-S)

  6 weeks to 18 months post-procedure.

Secondary Outcomes (3)

• Post-procedure pain flare

  Daily visual analog scale (VAS) for pain for the first 6 weeks.

• Pain medication usage

  6 weeks to 18 months post-procedure.

• Cost effectiveness

  Costs compared based on procedural data upon study completion, an average of 18 months.

Other Outcomes (1)

• Participation in physical therapy

  6 weeks to 18 months post-procedure.

Study Arms (2)

Ultrasound-Guided SIJ RFA

EXPERIMENTAL

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.

Procedure: Ultrasound-guided Radiofrequency Ablation

Fluoroscopic-Guided SIJ RFA

ACTIVE COMPARATOR

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.

Procedure: Fluoroscopic-guided Radiofrequency Ablation

Interventions

Fluoroscopic-guided Radiofrequency Ablation PROCEDURE

Radiofrequency ablation of the posterior SIJ complex under fluoroscopic-guidance

Fluoroscopic-Guided SIJ RFA

Ultrasound-guided Radiofrequency Ablation PROCEDURE

Radiofrequency ablation of the posterior SIJ complex under ultrasound-guidance

Ultrasound-Guided SIJ RFA

Eligibility Criteria

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

You may qualify if:

• 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).
• Diagnosis confirmed by having \>70% index pain relief with fluoroscopy-guided SIJ lateral branch blocks (with local anesthetic). Participants will require confirmatory lateral branch block under their respective image modality once randomized, requiring \>70% pain relief for diagnosis, prior to completing the randomized SIJ RFA procedure.

You may not qualify if:

• Age \<18
• Pregnant or inadequate birth control methods (to prevent the exposure of a pregnant female and/or fetus to radiation).
• Inflammatory spondyloarthropathy
• Fibromyalgia
• Radiculopathy (will require an electromyography study to rule out radiculopathy if clinically suspected in patients with primarily buttock pain)
• Discogenic low mechanical back pain
• Symptomatic spinal stenosis
• Generalized or local infection
• Coagulopathy
• Allergy to local anesthetic

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

HealthPointe

Edmonton, Alberta, T6X 0S8, Canada

Location

Related Publications (7)

• Aydin SM, Gharibo CG, Mehnert M, Stitik TP. The role of radiofrequency ablation for sacroiliac joint pain: a meta-analysis. PM R. 2010 Sep;2(9):842-51. doi: 10.1016/j.pmrj.2010.03.035.

  PMID: 20869684 BACKGROUND

• Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148.

  PMID: 23253394 BACKGROUND

• Dreyfuss P, Henning T, Malladi N, Goldstein B, Bogduk N. The ability of multi-site, multi-depth sacral lateral branch blocks to anesthetize the sacroiliac joint complex. Pain Med. 2009 May-Jun;10(4):679-88. doi: 10.1111/j.1526-4637.2009.00631.x.

  PMID: 19638143 BACKGROUND

• Finlayson RJ, Etheridge JB, Elgueta MF, Thonnagith A, De Villiers F, Nelems B, Tran DQ. A Randomized Comparison Between Ultrasound- and Fluoroscopy-Guided Sacral Lateral Branch Blocks. Reg Anesth Pain Med. 2017 May/Jun;42(3):400-406. doi: 10.1097/AAP.0000000000000569.

  PMID: 28178092 BACKGROUND

• Roberts SL, Burnham RS, Ravichandiran K, Agur AM, Loh EY. Cadaveric study of sacroiliac joint innervation: implications for diagnostic blocks and radiofrequency ablation. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):456-64. doi: 10.1097/AAP.0000000000000156.

  PMID: 25304483 BACKGROUND

• Roberts SL, Burnham RS, Agur AM, Loh EY. A Cadaveric Study Evaluating the Feasibility of an Ultrasound-Guided Diagnostic Block and Radiofrequency Ablation Technique for Sacroiliac Joint Pain. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):69-74. doi: 10.1097/AAP.0000000000000515.

  PMID: 27811527 BACKGROUND

• Roberts SL, Stout A, Loh EY, Swain N, Dreyfuss P, Agur AM. Anatomical Comparison of Radiofrequency Ablation Techniques for Sacroiliac Joint Pain. Pain Med. 2018 Oct 1;19(10):1924-1943. doi: 10.1093/pm/pnx329.

  PMID: 29415262 BACKGROUND

MeSH Terms

Interventions

Transurethral Resection of Prostate

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Shane Hoeber, M.D.

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In terms of blinding, the principal investigators will be blinded to which arm each study participant is randomized to. It is not possible to blind study participants, as they will be aware of the imaging modality used to perform the procedure. The clinicians serving as private investigators (one in each study arm) will not be blinded to the procedure they are performing. Therefore, this is a single-blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who present with pain thought to be originating from the SIJ will be screened for study participation with fluoroscopy-guided sacral lateral branch blocks (LBB). If a patient has an initial successful sacral LBB (defined as 70% reduction in pain), or has prior successful SIJ RFA, they will be approached for consent to be contacted for study participation. Upon obtaining written consent for study participation, patients will be randomized into one of two groups; US-guided SIJ RFA or fluoroscopy-guided SIJ RFA (current gold-standard). Upon being randomized to either group they will then undergo a second confirmatory sacral LBB under their respective image guidance to confirm candidacy for RFA. If this second, confirmatory LBB is successful (70% pain relief) they qualify for RFA. Then, SIJ RFA will be performed under each respective imaging modality and patients will be followed to document pain improvement, functional outcomes, quality of life and medication use for 18 months.

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: September 1, 2020
• Study Start: January 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: January 1, 2023
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)