Self-Treatment of Chronic Low Back Pain Based on a Rapid and Objective Sacroiliac Asymmetry Test: A Randomized Open Label Trial

Abstract

Background: Low back pain (LBP) is common, costly, and disabling. This study assesses a novel and simple LBP evaluation method and its merit in guiding the direction of a self-treatment exercise. Methods: Randomized open label intention to treat study. Consecutive patients with LBP ≥ 3 months and pain ≥ 5/10 were evaluated in a Vancouver clinic with the sacroiliac forward flexion test (SIFFT), which compares the height of posterior superior iliac spines using a level. Those with asymmetry ≥ 5 mm were offered participation. The assistant, who generated and encrypted the randomization, assigned participants: group 1 learned a two-minute, SIFFT-derived, sacroiliac-leveling exercise (SIFFT-E) as needed for LBP relief, group 2 used a pelvic stabilization belt as needed to prevent LBP and group 3 continued usual care. After one month all participants used SIFFT-E and belt as needed for one month. Clinicaltrials.gov # NCT03888235. Trial closed. The Oswestry Disability Index (ODI) (decrease) from baseline to 1 and 2 months was our primary outcome measure. SIFFT improvement (decrease) was also followed. Findings: Of 72 LBP patients, 62 (86%) had ≥5mm asymmetry. Non-exercise control subgroups performed similar statistically. From 0-1 month the 21(one dropout) SIFFT-E participants outperformed the combined 41(one dropout) controls for ODI improvement (12·5±14·8 vs.0·5±14·9 points; mean difference12 points [CI 4·0-20·0]; p=·004 with NNT of 3·2 for improvement of 11 and for SIFFT improvement (7·3±9mm vs.2·1±9mm; mean difference 5·25mm [CI 2·3-10·2mm]; p=·041). At 2 months, after all 62 participants used exercise and belt as needed, ODI and SI asymmetry improvements were clinically significant (12·0±18·4 points (p<·001) and 8·6±8·6mm (p<·001) respectively). Five (8%) exercise and 12(19%) belt wearers experienced mild side effects. Interpretation: Sacroiliac asymmetry was frequent and correctable with SIFFT-guided exercise, resulting in significant improvement in back pain and function. Replication as a larger study is merited. Trial Registration: Clinicaltrials.gov # NCT03888235. Funding: Self-Funded Declaration of Interest: Dr. Helene Bertrand is a shareholder and director of MaryHelene Enterprises Inc. which holds a Canadian and US patent for the use of mannitol as a topical pain reliever. It markets, distributes and sells QR cream, which contains mannitol. None of the other authors have interests to declare. Ethical Approval: This randomized open label study was carried out in a family practice in North Vancouver, Canada. The University of British Columbia Clinical Research Ethics Board approved it. (H19- 01224).