Home-based Cycling for People With Lumbar Spinal Stenosis (FLEXCAL)

Assistance Publique - Hôpitaux de Paris

Status and phase: Enrolling; Phase 3

Conditions: Symptomatic Lumbar Spinal Stenosis

Treatments: Other: Home-based cycling program; Other: usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04075539

2023-A00601-44 (Other Identifier)

P160147

Details and patient eligibility

About

The main objective of the study is to compare the efficacy on back-specific activity limitations at 4 months after-randomisation of home-based cycling using connected ergometric bicycles associated with usual care to usual care.

Full description

Lumbar spinal stenosis is a prevalent and disabling condition in elderly people. Lumbar spinal stenosis results in back and leg pain when standing and walking (radicular claudication), while symptoms regress in sitting position. The inability to stand or walk significantly impairs functioning and health-related quality of life of elders, and has an important healthcare cost.

The 2 main treatment options for lumbar spinal stenosis are conservative or surgical treatments. Previous data suggested that laminectomy may be more effective on pain and function than conservative therapy. However, the benefit-risk balance of surgery should be carefully considered in this population with numerous co-morbidities, and evidence is inconsistent. Therefore, conservative therapy is usually the first line option. Data regarding exercise therapy are scarce. Flexion-based exercises are usually recommended. A pilot study suggested that flexion-based endurance training program, namely cycling, could be an effective and safe method to improve pain, function and health-related quality of life in elderly people with chronic lumbar pain. However, barriers to adhering to the program were detected and might have influenced clinical endpoints. Non-pharmacological interventions in spinal conditions are not 'one-size-fits-all' and measures to enhance adherence have to be applied.

The hypothesis is that home-based cycling using connected ergometric bicycles associated with usual care could be more effective than usual care in reducing back-specific activity limitations at 4 months in people with lumbar spinal stenosis.

Enrollment: 302 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 50 year-old
• radicular claudication (i.e. walking-induced low back, buttock and/or leg pain, relieved in siting and/or lumbar flexion positions) diagnosed by a physician
• MRI or CT-scan findings consistent with LSS reported on a written radiology report provided by a board-certified radiologist or a resident in radiology

Exclusion criteria

• inability to speak and/or read French language
• inability or refusal to perform ergometric bicycle at home
• patients already having an ergometric bicycle at home
• history of lumbar spine surgery in the previous 12 months
• cognitive disorders
• severe neurologic or vascular disorders involving the lower limbs
• contraindication to a rehabilitation program assessed by medical examination
• people under tutorship or curatorship
• protected adults

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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302 participants in 2 patient groups

Home-based cycling program associated to usual care

Experimental group

Treatment:

Other: Home-based cycling program

Outpatient physiotherapy

Other group

Treatment:

Other: usual care