Effect of a Prototype Lumbar Spinal Stenosis Belt versus a Lumbar Support on Walking Capacity in Lumbar Spinal Stenosis: A Randomized Controlled Trial

Publication date: Available online 25 July 2018

Source: The Spine Journal

Author(s): Carlo Ammendolia, Y. Raja Rampersaud, Danielle Southerst, Aksa Ahmed, Michael Schneider, Gillian Hawker, Claire Bombardier, Pierre Côté

Abstract

Background Context

Lumbar spinal stenosis (LSS) can impair blood flow to the spinal nerves giving rise to neurogenic claudication and limited walking ability. Reducing lumbar lordosis can increases the volume of the spinal canal and reduce neuro-ischemia. We developed a prototype LSS belt aimed at reducing lumbar lordosis while walking.

Purpose

The aim of this study was to assess the short-term effectiveness of a prototype LSS belt compared to a lumbar support in improving walking ability in patients with degenerative LSS.

Study Design

This was a two-arm, double-blinded (participant and assessor) randomized controlled trial.

Patient Sample

We recruited 104 participants 50 years of age or older with neurogenic claudication, imaging confirmed degenerative LSS, and limited walking ability.

Outcome Measures

The primary measure was walking distance measured by the self-paced walking test (SPWT) and the primary outcome was the difference in proportions among participants in both groups who achieved at least a 30% improvement in walking distance from baseline using relative risk with 95% confidence intervals.

Methods

Within one week of a baseline SPWT, participants randomized to the prototype LSS belt group (n=52) and those randomized to the lumbar support group (n=52) performed a SPWT that was conducted by a blinded assessor. The Arthritis Society funded this study ($365,000 CAN) with salary support for principal investigator funded by the Canadian Chiropractic Research Foundation ($500,000 CAN for 5 years).

Results

Both groups showed significant improvement in walking distance but there was no significant difference between groups. The mean group difference in walking distance was -74m (95% CI: -282.8 to 134.8, P=0.49). A total of 62% of participants wearing the prototype LSS belt and 82% of participants wearing the lumbar support achieved at least 30% improvement in walking distance (relative risk, 0.7; 95% CI: 0.5 to 1.3, P=0.43).

Conclusions

A prototype LSS belt demonstrated significant improvement in walking ability in degenerative LSS but was no better than a lumbar support.

Registration

ClinicalTrials.gov ID: NCT02592642

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