Lumbar Spinal Stenosis
Conditions
Keywords
Lumbar spinal stenosis, Cycling, Lumbar-flexion-based training
Brief summary
The purpose of this study is to determine whether a home-based cycling program for patients with lumbar spinal stenosis is a feasible and acceptable
Detailed description
Lumbar spinal stenosis is a prevalent and disabling condition in elderly individuals. Lumbar spinal stenosis results in lumbar and/or radicular leg pain when standing and walking, while symptoms regress in lumbar flexion positions and at rest. The inability to stand or walk 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. Laminectomy may be more effective on pain and function than conservative therapy. However, the benefit-risk balance of surgery should be considered in this population with numerous co-morbidities, and evidence is inconsistent. Therefore, conservative therapy is usually the first line option to avoid or delay surgery. Data regarding exercise therapy are scarce. Lumbar-flexion-based exercises are usually recommended. A pilot study suggested that lumbar-flexion-based endurance training, namely cycling, could be an effective and safe method to improve pain, function and health-related quality of life in elderly patients with chronic low back pain but barriers to adhering to the program were detected. Investigators aim to assess barriers and facilitators to a 3-month home-based cycling program in lumbar spinal stenosis.
Interventions
A single outpatient supervised session followed by a 3-month home-based cycling program tailored to patients' preferences
Sponsors
Study design
Eligibility
Inclusion criteria
* Fulfilment of International Society for the Study of Lumbar Spine clinical diagnosis criteria for lumbar spinal stenosis with the presence of at least 6 out of the 7 following criteria: pain in the buttocks or legs while walking; flex forward to relieve symptoms; feel relief when using a shopping cart or bicycle; motor or sensory disturbance while walking; normal and symmetric foot pulses; lower extremity weakness; and low back pain * Lumbar spinal stenosis qualitatively detected on MRI or CT-scan
Exclusion criteria
* Inability to speak or read French * Impossibility or refusal to have an ergometric bicycle at home * Ongoing lumbar-flexion-based endurance training * History of spinal surgery * Cognitive impairment * Neurological or vascular disorder involving the lower limbs * Contraindication to cycling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facilitators to home-based cycling | 3 months | Assessed by a qualitative approach using semi-structured interviews |
| Barriers to home-based cycling | 3 months | Assessed by a qualitative approach using semi-structured interviews |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barriers to home-based cycling | Baseline | Assessed by a qualitative approach using semi-structured interviews |
| Facilitators to home-based cycling | Baseline | Assessed by a qualitative approach using semi-structured interviews |
| Number of training sessions to assess adherence to home-based cycling | 3 months | assessed by automatic monitoring on a USB stick connected to the bicycle |
| Covered distance to assess adherence to home-based cycling | 3 months | assessed by automatic monitoring on a USB stick connected to the bicycle |
| Duration of training sessions to assess adherence to home-based cycling | 3 months | Number of training sessions, distance, duration and power assessed by automatic monitoring on a USB stick connected to the bicycle |
| Developed power to assess adherence to home-based cycling | 3 months | assessed by automatic monitoring on a USB stick connected to the bicycle |
| Burden of a home-based cycling | 3 months | Assessed by the Exercise Therapy Burden Questionnaire (0=no burden, and 100=maximal burden) |
| Mean change from baseline in mean lumbar pain in the past 48 hrs | 3 months | Assessed by an 11-point numeric rating scale (0=no pan, and 100=maximal pain) |
| Mean change from baseline in mean radicular pain in the past 48 hrs | 3 months | Assessed by an 11-point numeric rating scale (0=no pain, and 100=maximal pain) |
| Mean change from baseline in mean disability in the past 48 hrs | 3 months | Assessed by an 11-point numeric rating scale (0=no disability, and 100=maximal disability) |
| Mean change from baseline in mean spine-specific activity limitation | 3 months | Assessed by the Oswestry Disability Index (0=no limitation, and 100=maximal limitation) |
| Mean change from baseline in mean maximum walking distance | 3 months | Assessed by an adapted version of the self-paced walking test |
Countries
France