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Referred leg pain originating from the sacroiliac joint: 6-month outcomes from the prospective randomized controlled iMIA trial

  • Original Article - Spine
  • Published:
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Abstract

Background

The first results from the randomized, controlled iFuse Implant System Minimally Invasive Arthrodesis (iMIA) trial showed that minimally invasive surgical management (MISM) of low back pain originating from the sacroiliac joint (SIJ) by placing transarticular triangular titanium implants reduced pain more effectively than conservative management (CM). We now conducted a separate analysis of the iMIA data to assess whether the referred leg pain (RLP) component of SIJ-associated pain may also be affected by MISM or CM.

Methods

Data from 101 patients, recruited between June 2013 and May 2015 at nine European spine care centers, were included. Forty-nine patients were randomized to CM and 51 patients to MISM. RLP was defined as pain below the gluteal fold and assessed using the visual analogue scale (VAS). Changes in RLP over 6 months were the primary endpoint.

Results

The prevalence of clinically significant RLP was 76.2 %. Over 6 months of follow-up, CM produced no significant change in RLP, which was 51.0 VAS points (interquartile range (IQR) 17.0–75.0) at baseline. In contrast, in the MISM cohort, we found a significant decrease in RLP from VAS 58.0 (IQR 24.5–80.0) at baseline to VAS 13.5 (IQR 0.0–39.3) after 6 months (p < 0.01). Improvement of RLP was associated only with the type of treatment (OR 5.04, p < 0.01), but not with patient age, sex, or different patterns of pain referral.

Conclusions

Our analysis shows that RLP is a frequent phenomenon in patients with SIJ-associated pain. At 6 months of follow-up, MISM helped relieve RLP more effectively than CM.

Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01741025.

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Acknowledgments

The iMIA trial was funded by SI-BONE Inc. (San Jose, CA, USA). BS, DK, and RP have received personal fees from SI-BONE. JD has received a research grant from the German Federal Ministry of Education and Research via a grant from the Center for Stroke Research Berlin not related to this project. PV has received personal fees from Brainlab and Ulrich medical not related to this project.

Author information

Authors and Affiliations

  1. Department of Neurosurgery, Charité - Universitaetsmedizin Berlin, Campus Virchow Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany

    Julius Dengler, Emanuel Erk & Peter Vajkoczy

  2. Department of Orthopedics, Ängelholm Hospital, Ängelholm, Sweden

    Bengt Sturesson

  3. Department of Neurosurgery, Onze-Lieve-Vrouw Hospital Aalst, Aalst, Belgium

    Djaya Kools

  4. Department of Orthopedics and Traumatology, Ospedale Civile di Legnano, Legnano, Italy

    Domenico Prestamburgo

  5. SI-BONE, Inc., San Jose, CA, USA

    Daniel Cher

  6. Eeckhoven bvba, Kontich, Belgium

    Eddie van Eeckhoven

  7. Department of Orthopedics and Traumatology, University Hospital Bonn, Bonn, Germany

    Robert Pflugmacher

Authors
  1. Julius Dengler
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  2. Bengt Sturesson
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  3. Djaya Kools
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  4. Domenico Prestamburgo
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  5. Daniel Cher
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  6. Eddie van Eeckhoven
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  7. Emanuel Erk
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  8. Robert Pflugmacher
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  9. Peter Vajkoczy
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Consortia

and the iMIA study group

  • D. Kools
  • , G. Lesage
  • , F. Martens
  • , H. Keymeulen
  • , Y. Lecomte
  • , J. Dengler
  • , S. Bayerl
  • , R. Pflugmacher
  • , M. Webler
  • , R. Bornemann
  • , A. Mues
  • , A. Gasbarrini
  • , C. Griffoni
  • , S. Colangeli
  • , R. Ghermandi
  • , D. Prestamburgo
  • , F. Valli
  • , P. Gaetani
  • , V. Silvani
  • , M. Minelli
  • , S. Vottorio
  • , D. Adinolfi
  • , M. Verlotta
  • , A. Cattalani
  • , B. Sturesson
  •  & I. Dahlberg

Corresponding author

Correspondence to Julius Dengler.

Ethics declarations

Conflict of interest

DP and EE have no conflicts of interest to report.

Ethical approval

All procedures performed in the iMIA trial were in accordance with the ethical standards of the ethics committees of all participating centers and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Funding

SI-BONE Inc. (San Jose, CA, USA) provided financial support in the form of funding the iMIA trial. SI-BONE Inc. participated in the design of the iMIA trial and in the coordination of the clinical research conducted for it at the participating centers.

Additional information

Comments

Sacroiliac joint dysfunction shares common symptomatology with other lower spinal pain syndromes, especially when referred leg pain is a feature. The present multi-center study on minimally invasive sacro-iliac joint fusion was designed to compare this procedure with conservative management in lower back/pelvic pain. The authors present a subgroup analysis of patients with referred leg pain that responded favorably to the surgical procedure when compared to controls. Follow-up is short at 6 months and should be extended as the authors acknowledge. This is a well-designed study of a new surgical procedure that addresses a common and under-diagnosed pathology and its symptom spectrum.

Zvi Harry Rappaport

Petah Tiqva, Israel

No parts of this project have been presented anywhere before.

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Dengler, J., Sturesson, B., Kools, D. et al. Referred leg pain originating from the sacroiliac joint: 6-month outcomes from the prospective randomized controlled iMIA trial. Acta Neurochir 158, 2219–2224 (2016). https://doi.org/10.1007/s00701-016-2953-7

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  • DOI: https://doi.org/10.1007/s00701-016-2953-7

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