Abstract
BACKGROUND: Lumbar spinal stenosis (LSS) causing neurogenic claudication (NC) is a leading cause of disability which is intimately related to a decrease in walking capacity. Walking limitation has negative physical and mental impacts on patients. Recent guidelines recommend the use of conservative treatment options such as exercises before considering surgery. Unfortunately, dedicated healthcare resources for the conservative management of patients with LSS causing NC are uncommon. Thus, it is important to develop accessible and specific rehabilitation programs aimed at improving patients' self-management, especially with regard to walking capacity. The aim of this study is to evaluate the effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with LSS causing NC. METHODS/DESIGN: This is a prospective randomized controlled parallel-group clinical trial. Sixty-six patients with LSS causing NC will be recruited from identified clinics and local advertisements. The intervention group will receive standardized education and specific exercises while the control group will only receive a standardized education. The program in both groups will last for 6 weeks with 5 evaluation time points (baseline, week 2, week 4, week 6, and week 12). The primary outcome will be walking capacity measured with the Self-Paced Walking Test, and the secondary outcomes will be back and leg pain intensity, LSS-related disability, self-efficacy, level of physical activity, anxiety, depression, gait pattern characteristics, balance, and global perceived change. DISCUSSION: This study will assess the effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with LSS causing NC. By measuring objective gait pattern characteristics, the study will also provide new information about the impact of NC on gait pattern that could eventually improve the evaluation and the management of LSS. TRIAL REGISTRATION: ClinicalTrials.gov NCT05513326 . Registered on August 22, 2022.