Clinical trial NCT05513326: Effectiveness of a 6-week Specific Rehabilitation Program on Walking Capacity in Patients with Lumbar Spinal Stenosis
Official title: Effectiveness of a 6-week Specific Rehabilitation Program Combining Education and Exercises on Walking Capacity in Patients with Lumbar Spinal Stenosis with Neurogenic Claudication
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Stenosis
Keywords: Spinal Stenosis
Neurogenic claudication
Walking capacity
Exercises
Education
gait pattern characteristics
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 66
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with LSS causing NC.

The intervention group will receive standardized education and specific exercises while the control group will only receive standardized education. The program in both groups will last for 6 weeks with 4 evaluation timepoints (baseline, week 2, week 4 and post-intervention assessment). The primary outcomes 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 and depression, physical activity level, gait pattern characteristics, balance, and global perceived change.


Eligibility criteria: Inclusion Criteria:

* being at least 50 years old
* having a degenerative central LSS alone or in combination with other LSS types (e.g. foraminal, lateral) and/or a spondylolisthesis affecting one or multiple vertebral levels, confirmed by clinical history, physical examination and proper imaging
* having NC associated with LSS
* being able to speak and understand French
* being willing to attend 3 intervention sessions per week
* with a duration of signs and symptoms of at least 3 months
* (7) being able to walk at least 20 meters without walking aid, but not being able to walk continuously for 30 minutes
* being able to provide informed written consent.

Exclusion Criteria:

* congenital LSS,
* symptomatic osteoarthritis (hip or knee) causing limited walking capacity
* neurological disease affecting walking capacity such as Parkinson
* uncontrolled diabetes
* heart failure
* intermittent claudication of vascular origin
* impaired cognitive capacity
* back or lower extremities surgery in the past 3 months

Primary outcomes:
measure: Change from baseline in walking capacity
timeFrame: Baseline, week 2, week 4, week 6, week 12
Secondary outcomes:
measure: Change from baseline in leg and back pain intensity
timeFrame: Baseline, week 2, week 4, week 6, week 12
measure: Change from baseline in lumbar spinal stenosis related disabiltity
timeFrame: Baseline, week 6, week 12
measure: Changes from baseline in self-efficacy
timeFrame: Baseline, week 6, week 12
measure: Change from baseline in anxiety and depression
timeFrame: Baseline, week 6, week 12
measure: Change from baseline in physical activity level
timeFrame: Baseline, week 6, week 12
measure: Patient's global impression of change
timeFrame: changes of the global impression of change throughout the study (baseline, week 2, week 4, week 6, week 12)
measure: Change from baseline in biomechanical parameters of gait
timeFrame: Baseline, week 2, week 4, week 6, week 12
measure: Change from baseline in biomechanical parameters of gait
timeFrame: Baseline, week 2, week 4, week 6, week 12
measure: Change from baseline in biomechanical parameters of gait
timeFrame: Baseline, week 2, week 4, week 6, week 12
measure: Change from baseline in lower extremity physical function and balance
timeFrame: Baseline, week 6, week 12
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Université du Québec à Trois-Rivières
state: Quebec
Study officials:
References: