Effectiveness of a 6-week Specific Rehabilitation Program on Walking Capacity in Patients With Lumbar Spinal Stenosis

Spinal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05513326
• Other study ID #: UQTR-2022-program
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Université du Québec à Trois-Rivières
• Contact: Mariève Houle, PhD(c)
• Phone: 819 376-5011
• Email: marieve.houle[@]uqtr.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis

Intervention

Other:
• Exercises and education
Exercises: 3 training sessions per week that will last for 30 minutes. Sessions will start with 5 minutes of activation (walking on a treadmill or cycling). Then, participants will be asked to complete 5 exercises targeting lower limb strengthening (time: 18 minutes) followed by 2 exercises designed to improve balance and 3 stretching exercises for the lower limb (time: 7 minutes). Education: Two one-on-one sessions (during week 2 and week 4 assessments) during which participants will receive information directly related to LSS and NC using illustration and videos. Participants will also be invited to ask their questions.
• Education alone
Education: Two one-on-one sessions (during week 2 and week 4 assessments) during which participants will receive information directly related to LSS and NC using illustration and videos. Participants will also be invited to ask their questions.

Locations

Country	Name	City	State
Canada	Université du Québec à Trois-Rivières	Trois-Rivières	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université du Québec à Trois-Rivières

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in walking capacity	Walking capacity measure with the Self-Paced Walking Test (time)	Baseline, week 2, week 4, week 6, week 12
Secondary	Change from baseline in leg and back pain intensity	Leg and back pain intensity will be independently assessed using a 11-point numerical rating scale (from 0 to 10 points). Higher score indicates higher pain.	Baseline, week 2, week 4, week 6, week 12
Secondary	Change from baseline in lumbar spinal stenosis related disabiltity	Lumbar spinal stenosis related disability is measured with the French-Canadian version of the Swiss Spinal Stenosis Questionnaire. Pain, function and satisfaction related to lumbar spinal stenosis. Pain subscale score range from 7 to 35 with higher values indicate a worst outcome, Function subscale score range from 5 to 20 with higher values indicate a worst outcome, Satisfaction subscale score range from 6 to 24 with higher values indicate a worst outcome. The total score is composed of the three subscales and range from 18 to 79.	Baseline, week 6, week 12
Secondary	Changes from baseline in self-efficacy	Measured with Self-efficacy measured with the French-Canadian Chronic Pain Self-Efficacy Scale. Each question is rated on a numerical scale (from 1 to 10). Total is calculated using the mean of the 33-items scores and ranges from 1 to 10 with a higher score indicate higher self-efficacy.	Baseline, week 6, week 12
Secondary	Change from baseline in anxiety and depression	Measured with the French-Canadian adaptation of the Hospital Anxiety and Depression Scale. Total score range from 0 to 21 with higher score indicating symptoms of anxiety and/or depression.	Baseline, week 6, week 12
Secondary	Change from baseline in physical activity level	Physical activity level assessed with the [Physical Activity Questionnaire for the Elderly]. The questionnaire allows to place participants into one of the 3 categories (low, moderate or high physical activity level). Physical activity level is measured in time per day.	Baseline, week 6, week 12
Secondary	Patient's global impression of change	Global impression of change will be measured using a 7-point scale that ranges from 'very much improved' to 'very much worse' with 'no change' as the mid-point.	changes of the global impression of change throughout the study (baseline, week 2, week 4, week 6, week 12)
Secondary	Change from baseline in biomechanical parameters of gait	Spatio-temporal parameters of gait measured with wearable inertial sensors (velocity (m/s))	Baseline, week 2, week 4, week 6, week 12
Secondary	Change from baseline in biomechanical parameters of gait	Spatio-temporal parameters of gait measured with wearable inertial sensors measured in meters (stride length, swing witdh, toe clearance)	Baseline, week 2, week 4, week 6, week 12
Secondary	Change from baseline in biomechanical parameters of gait	Spatio-temporal parameters of gait measured with wearable inertial sensors measured in % (walking phases, assymetry, variability)	Baseline, week 2, week 4, week 6, week 12
Secondary	Change from baseline in lower extremity physical function and balance	Lower extremity physical function and balance measured with the Short Physical Performance Battery. Total score ranges from 0 to 12 with higher score indicating a better lower extremity physical function and balance.	Baseline, week 6, week 12