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Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Radiofrequency Ablation

NCT04534829 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-06-01

No results posted yet for this study

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

Interventions

PROCEDURE

Fluoroscopic-guided Radiofrequency Ablation

Radiofrequency ablation of the posterior SIJ complex under fluoroscopic-guidance

PROCEDURE

Ultrasound-guided Radiofrequency Ablation

Radiofrequency ablation of the posterior SIJ complex under ultrasound-guidance

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Shane Hoeber, M.D. · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2022-06-30
Completion
2023-01-31

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 NCT04534829 on ClinicalTrials.gov