Abstract
Background and purpose — The sacroiliac joint is increasingly recognized as a cause of pain in 15–30% of patients with low back pain. Nonoperative management is not always successful and surgical treatment with fusion of the joint is increasingly recommended. According to the literature, minimally invasive fusion reduces pain and improves function compared with nonoperative treatment. It is, however, unclear to what extent the placebo effect influences these results. Patients and methods — The trial is designed as a prospective multi-center, double-blind, randomized sham-surgery controlled trial with 2 parallel groups. 60 patients with a suspected diagnosis of sacroiliac joint pain confirmed with sacroiliac joint injection are included according to the trial inclusion criteria. Patients are randomized with a 1:1 allocation into 2 groups of 30 patients each. The primary end-point is group difference in sacroiliac joint pain intensity on the operated side at 6 months postoperatively, measured by the Numeric Rating Scale. The main objective is to examine whether there is a difference in pain reduction between patients treated with a minimally invasive fusion of the sacroiliac joint compared with patients undergoing a sham operation. Results — Unblinding occurs after the completed 6-month follow-up. The primary analysis will be performed when all patients have completed 6 months’ follow-up. Follow-ups are continued to at least 2 years postoperatively. Data from the different groups will be compared based on the “intention to treat” principle.
Highlights
Patients and methods — The trial is designed as a prospective multi-center, double-blind, randomized shamsurgery controlled trial with 2 parallel groups. 60 patients with a suspected diagnosis of sacroiliac joint pain confirmed with sacroiliac joint injection are included according to the trial inclusion criteria
The main objective is to examine whether there is a difference in pain reduction between patients treated with a minimally invasive fusion of the sacroiliac joint compared with patients undergoing a sham operation
minimally invasive (MIS) Sacroiliac joint (SIJ) fusion is increasingly used worldwide with reported reduced pain, and improved physical function and quality of life compared with nonoperative treatment in two industrysponsored randomized sham-surgery controlled trial (RCT) [16,19]
Summary
The trial is designed as a prospective multi-center, doubleblinded, randomized sham-surgery controlled trial with 2 parallel groups. Referrals from general practitioners and from departments of orthopedic surgery or physical medicine and rehabilitation are screened for eligibility by an orthopedic consultant in the 2 departments and all patients whose referral includes information concerning pain originating from the SIJ are included for evaluation This baseline evaluation is performed at the hospital’s outpatient clinics with standardized clinical examination in accordance with inclusion and exclusion criteria (Table 1). Patients with prior SIJ surgery same pre- and postoperative assessment (i.e., blood samples, general anesthesia, draping, wound care, and pain medication). They will not be randomized before they are under general anesthesia. Patients randomized to the intervention group (cases) receive treatment with triangular titanium implants according to the Screening in the outpatient clinic
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