Clinical Outcomes of a New Foot-Worn Non-Invasive Biomechanical Intervention Compared to Traditional Physical Therapy in Patients With Chronic Low Back Pain. A Randomized Clinical Trial.

Abstract

Study design: Randomized Controlled Trial.

Objective: Chronic low back pain (CLBP) is a major public health concern that will continue to grow with the expected aging of the population. The purpose of this study was to examine the clinical effect of a personalized, home-based biomechanical intervention compared to traditional physical therapy in patients with CLBP.

Methods: This was a randomized controlled trial. One-hundred and sixty-two patients were randomized in a 2:1 ratio to a home-based biomechanical intervention (HBBI, AposHealth) or traditional physical therapy (TPT), respectively. Patients were assessed at baseline and after 12 weeks and 52 weeks. The primary outcome measure was pain at 52 weeks, using a standard Numeric Rating Scale (NRS). Secondary outcomes included pain and function metrics, quality of life and objective spatio-temporal gait test. A Linear Mixed Model assessed changes over time across all study visits.

Results: A significant reduction in NRS was found after 52 weeks with a superiority effect of the HBBI arm compared to TPT (F = 13.82, P < 0.001). Patients in the HBBI arm demonstrated a marginal mean reduction of 3.5 points, from 6.2 to 2.7 (a 56% reduction), while patients in the TPT arm reported a mean decrease of 1.8 points from 6.9 to 5.1 (a 26% reduction).

Conclusions: A new foot-worn, home-based, biomechanical intervention for patients with chronic non-specific back pain was found to be clinically effective. Given the lack of non-surgical, non-pharmacological interventions for this populations, this treatment might serve as an adjunct to the current standard of care.