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

U

Université du Québec à Trois-Rivières

Status

Enrolling

Conditions

Spinal Stenosis

Treatments

Other: Education alone
Other: Exercises and education

Study type

Interventional

Funder types

Other

Identifiers

NCT05513326
UQTR-2022-program

Details and patient eligibility

About

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.

Enrollment

66 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

66 participants in 2 patient groups

Intervention Group
Experimental group
Description:
Intervention group will received education and a specific rehabilitation program (exercises).
Treatment:
Other: Exercises and education
Control Group
Other group
Description:
Control group will received education alone.
Treatment:
Other: Education alone

Trial contacts and locations

1

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Central trial contact

Mariève Houle, PhD(c)

Data sourced from clinicaltrials.gov

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