Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain (SIFSO)

  • STATUS
    Not Recruiting
  • End date
    Apr 25, 2023
  • participants needed
    60
  • sponsor
    Oslo University Hospital
Updated on 27 June 2022

Summary

Sacroiliac joint fusion versus sham operasjon for treatment of sacroiliac pain. A prospective double blinded randomized controlled multicentre study.

Description

Sacroiliac(SI) joint pain can lead to long-lasting severe pain and reduce physical function. It is shown to be the source of pain in 13-30% of patients with low back pain. Former surgical techniques had a high level of complications and low success rates. Newer mini-invasive surgical approaches have shown promising results in scientific studies. It is difficult to find an adequate control group for surgery as most patients already have tried conservative and alternative treatments without effect. A sham-designed study is the best alternative. This study is designed as a prospective randomized double blinded controlled mulitcenter trial. The investigators want to examine whether there is a difference in SI joint pain in patients operated with miniinvasive arthrodesis of the SI joint compared to a sham operated control group. Patients with SI joint pain are included. They will be randomized to either surgery with arthrodesis or sham surgery. Neither patient nor health personell who work with the patient after the surgery will know what has been done. The primary end point for the study is group difference in sacroiliac joint pain on the operated side after 6 months.

Details
Condition Sacroiliac Joint Somatic Dysfunction
Treatment Sham group, fMRI Study, iFuse
Clinical Study IdentifierNCT03507049
SponsorOslo University Hospital
Last Modified on27 June 2022

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