Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration
- Conditions
- Lumbar Spinal Stenosis
- Interventions
- Other: Test groupOther: Control group (C)
- Registration Number
- NCT02610335
- Lead Sponsor
- University Hospital, Bordeaux
- Brief Summary
In actual practice the patients with mild or moderate lumbar spinal stenosis symptoms receive an epidural infiltration and participate in kyphosis reeducation in first intention. Yet the kyphosis reeducation did not show a real profit in the time compared with the natural evolution of the pathology. The study assume that the spinal mobility reeducation will reduce the incidence of pain recurrences compared with the classic kyphosis reeducation.
- Detailed Description
The standard treatment of lumbar spinal stenosis is the lumbar canal recalibration surgery which presents co-morbidity factors and risks of post-operative complications. The non-invasive methods are a good alternative compared with the surgery : the patients medically treated present few damages and the results of the postponed surgery are equivalent to the immediate surgery. That is why a non-surgical treatment is proposed in first intention to the patients with mild or moderate symptoms : this treatment associates an epidural infiltration and a kyphosis reeducation.
Yet the kyphosis reeducation did not show a real profit in the time compared with the natural evolution of the pathology. The benefits of the infiltration are lost three months after this one in 80 % of the cases. A return to physical activity and a restored spinal mobility would improve the duration of the infiltration effect. The objective is then to compare the efficiency of a spinal mobility reeducation program versus a kyphosis reeducation program in patients with acquired and central lumbar spinal stenosis. It is a prospective, monocentric, randomized, superiority and parallel-group study :
* group C (control group) : kyphosis reeducation + patient education + auto-reeducation at home,
* group M (test group) : spinal mobility reeducation + patient education + auto-reeducation at home.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
- age > 50 years,
- central, acquired and multi-staged lumbar spinal stenosis,
- pain since at least three months,
- radicular pains higher than the lumbar pains,
- walking distance < 1000 m,
- oral consent.
- intercurrent pathology limiting the walking distance (arteriopathy, cardio-respiratory insufficiency, disabling arthrosis affecting the lower limbs...),
- history of spinal surgery for lumbar spinal stenosis,
- extended lumbar arthrodesis (equal to or greater than 2 levels),
- monosegmental and degenerative spondylolisthesis,
- foraminal stenosis,
- motor deficit of the lower limbs or Cauda equina syndrome ("Cauda equina" syndrome (CES) is a serious neurologic condition in which damage to the cauda equina causes acute loss of function of the lumbar plexus, (nerve roots) of the spinal canal below the termination (conus medullaris) of the spinal cord),
- bleeding disorders or allergies contraindicating the epidural infiltration.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test group (M) Test group Spinal mobility reeducation + patient education + auto-reeducation at home. Control group (C) Control group (C) Kyphosis reeducation + patient education + auto-reeducation at home
- Primary Outcome Measures
Name Time Method maximal walking distance the 90 days visit : ratio between the maximal walking distance at the 90 days visit and the maximal walking distance at the Day 4 in percent. Walking on a plane road, 70 m in length, without obstacle and with markings every 10 meters (total length : not more than 2 km).
- Secondary Outcome Measures
Name Time Method score of "Douleur Neuropathique 4" (DN4 - neuropathy) Day 365 evaluation of the radicular pain Day 365 measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
score Medical Outcomes Study Short-Form General Health Survey 12 (health status) Day 365 maximal walking distance Day 365 maximal walking distance : on a defined road
compliance with the auto-reeducation at home Day 365 compliance with the auto-reeducation at home : questionnaire.
evaluation of the lumbar pain Day 365 evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
evaluation scales Day 365 evaluation scales : score of Quebec (functional impotence)
Score of Japanese Orthopaedic Association (llumbar radiculopathy) Day 365
Trial Locations
- Locations (1)
University Hospital of Bordeaux - Hospital Pellegrin
🇫🇷Bordeaux, France