Sacroiliac joint fusion versus sham operasjon for treatment of sacroiliac pain. A prospective double blinded randomized controlled multicentre study.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
63
ifuse will be implanted as described in section on the active comparator arm of the study.
sham surgery will be performed as desrcribed in section on sham comparator.
Quantitative sensory testing, cerebral MRI and functional MRI will be done to examine pain mechanism and activation in the central nervous system.
Rikshospitalet, Oslo University Hospital
Oslo, Norway
Karolinska University Hospital
Stockholm, Sweden
Primary outcome measure - Numeric Rating Scale operated side
the primary endpoint is group difference in Numeric Rating Scale(NRS) pain-score on the operated side at six months postoperatively. Numeric rating scale is a pain-score scale from 0-10, where 0 is no pain and 10 is worst possible pain.
Time frame: 6 months
Baseline NRS
Change from baseline Numeric Rating Scale (NRS) pain-score on the operated side at 3,6,12 and 24 months
Time frame: baseline, 3, 6, 12 and 24 months
Global NRS
Change from baseline global NRS at 3,6,12 and 24 months
Time frame: baseline,3 ,6 ,12 ,24 months
NRS on non-operated side
Change from baseline in non-operated side NRS at 3,6,12 and 24 months
Time frame: baseline, 3, 6, 12, 24 months
NRS leg pain
Change from baseline leg pain NRS at 3,6,12,24 months
Time frame: baseline, 3,6,12,24 months
Oswestry disability index (ODI)
Change in disability due to pelvic pain measured by Oswestry Disability Index(ODI) at 3,6,12,24 months
Time frame: baseline, 3, 6,12, 24 months
Pelvic girdle questionnaire
Change in disability due to pelvic pain measured by Pelvic Girdle Questionnaire(PGQ) at 3,6,12,24 months
Time frame: baseline, 3, 6, 12, 24 months
Quality of life (EQ-5D)
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Change in quality of life measured by EQ-5D at 3,6,12,24 months
Time frame: baseline, 3, 6, 12, 24 months
Device breakage, loosening or migration on CT of the sacroiliac joint
Device breakage loosening or migration at 12 months judged by clinical symptoms and CT of the sacroiliac joint.
Time frame: 12 months