A home-based biomechanical intervention using a foot-worn device may provide superior pain reduction and functional improvement compared to traditional physical therapy for patients with chronic low back pain, according to the results of a new randomized clinical trial.

The home-based biomechanical intervention (HBBI) group achieved significantly better outcomes at both 12 and 52 weeks of follow-up compared to the traditional physical therapy (TPT) group.

Pain Reduction with HBBI

Investigators from Montefiore Health System and Albert Einstein College of Medicine randomized 162 patients with chronic lower back pain (CLBP) in a 2:1 ratio to receive either the HBBI (AposHealth) or TPT. After 52 weeks, patients in the HBBI arm demonstrated a mean pain reduction of 3.5 points on the Numeric Rating Scale (NRS), from 6.2 to 2.7 (a 56% reduction), while the TPT group had a mean decrease of 1.8 points, from 6.9 to 5.1 (a 26% reduction).

The HBBI intervention met the Minimally Clinically Important Change threshold for NRS in patients with CLBP—defined as a reduction of at least 2.5 points—while the TPT group did not reach this benchmark.

"Given the lack of nonsurgical, nonpharmacological interventions for this population, this treatment might serve as an adjunct to the current standard of care," noted lead author Matthew N. Bartels, MD, and colleagues.

Functional Improvement Across Multiple Measures

The HBBI group also demonstrated superiority in all secondary outcome measures, including:

• Oswestry Disability Index (ODI): HBBI patients had a mean decrease of 12.1 points (32% reduction) versus 5.1 points (13.5% reduction) in the TPT group

• PROMIS pain: 7.3-point reduction versus 3.5

• PROMIS function: 11.5-point increase versus 2.9

• SF-36 overall score: 16-point increase versus 5.5

• Gait velocity: 13.5-point increase versus 6.5

Device Functionality

The AposHealth device, which is cleared by the U.S. Food and Drug Administration, consists of a specialized shoe with an interface that allows attachment of two convex pods to the plantar surface of the sole. The device is personally calibrated to each patient to alleviate pain while walking by adjusting the ground reaction force vectors through changes in the center of pressure.

The convex nature of the elements induces controlled perturbation that provides neuromuscular training. "Overall, the device setup aims to off-load and destabilize the joint through microinstability and retraining of the neuromuscular system and utilizes gait rehabilitation protocol to achieve healthier gait pattern and clinical relief simultaneously. This is fundamentally different than insoles, orthotics, wedges and braces, which aim to support the joint," noted investigators.

Patient Compliance and Long-Term Benefits

Patient compliance was notably higher in the HBBI group, with 77% of patients classified as compliant compared to only 6% in the TPT group. The researchers hypothesized that the persistent improvement in the HBBI group "was likely due in part to the continued use of the device over the duration of the study and may reflect the easier sustainment of treatment benefits with HBBI over the commonly seen loss of adherence to exercise in TPT."

Without ongoing care and compliance with a treatment plan, patients with CLBP typically experience a decline in symptoms over time. The biomechanical device addresses key factors influencing adherence to home-based exercise programs.

The authors declared having no competing interests.

Source: Global Spine Journal