Clinical trial NCT02610335: Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration
Official title: Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration. Randomized and Comparative Study: Kyphosis Reeducation Versus Spinal Mobility Reeducation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: lumbar spinal stenosis
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 23
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: maximal walking distance
timeFrame: the 90 days visit
Secondary outcomes:
measure: evaluation of the lumbar pain
timeFrame: Day 0
measure: evaluation of the lumbar pain
timeFrame: Day 4
measure: evaluation of the lumbar pain
timeFrame: Day 30
measure: evaluation of the lumbar pain
timeFrame: Day 90
measure: evaluation of the lumbar pain
timeFrame: Day 365
measure: evaluation of the radicular pain
timeFrame: Day 0
measure: evaluation of the radicular pain
timeFrame: Day 4
measure: evaluation of the radicular pain
timeFrame: Day 30
measure: evaluation of the radicular pain
timeFrame: Day 90
measure: evaluation of the radicular pain
timeFrame: Day 365
measure: evaluation scales
timeFrame: Day 0
measure: evaluation scales
timeFrame: Day 4
measure: evaluation scales
timeFrame: Day 30
measure: evaluation scales
timeFrame: Day 90
measure: evaluation scales
timeFrame: Day 365
measure: maximal walking distance
timeFrame: Day 0
measure: maximal walking distance
timeFrame: Day 4
measure: maximal walking distance
timeFrame: Day 30
measure: maximal walking distance
timeFrame: Day 90
measure: maximal walking distance
timeFrame: Day 365
measure: compliance with the auto-reeducation at home
timeFrame: Day 30
measure: compliance with the auto-reeducation at home
timeFrame: Day 90
measure: compliance with the auto-reeducation at home
timeFrame: Day 365
measure: Score of Japanese Orthopaedic Association (llumbar radiculopathy)
timeFrame: Day 4
measure: Score of Japanese Orthopaedic Association (llumbar radiculopathy)
timeFrame: Day 30
measure: Score of Japanese Orthopaedic Association (llumbar radiculopathy)
timeFrame: Day 90
measure: Score of Japanese Orthopaedic Association (llumbar radiculopathy)
timeFrame: Day 365
measure: score of "Douleur Neuropathique 4" (DN4 - neuropathy)
timeFrame: Day 4
measure: score of "Douleur Neuropathique 4" (DN4 - neuropathy)
timeFrame: Day 30
measure: score of "Douleur Neuropathique 4" (DN4 - neuropathy)
timeFrame: Day 90
measure: score of "Douleur Neuropathique 4" (DN4 - neuropathy)
timeFrame: Day 365
measure: score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
timeFrame: Day 4
measure: score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
timeFrame: Day 30
measure: score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
timeFrame: Day 90
measure: score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
timeFrame: Day 365
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital of Bordeaux - Hospital Pellegrin
Study officials:
affiliation: service de médecine physique et de réadaptation, Centre Hospitalier Universitaire de Bordeaux,
name: Mathieu DE-SÈZE, MD
role: STUDY_DIRECTOR
affiliation: USMR CHU Bordeaux
name: Antoine BENARD, MD
role: STUDY_CHAIR
References:
citation: Berney J. [Epidemiology of narrow spinal canal]. Neurochirurgie. 1994;40(3):174-8. French.
citation: Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257-70. doi: 10.1056/NEJMoa070302.
citation: Yamashita K, Ohzono K, Hiroshima K. Five-year outcomes of surgical treatment for degenerative lumbar spinal stenosis: a prospective observational study of symptom severity at standard intervals after surgery. Spine (Phila Pa 1976). 2006 Jun 1;31(13):1484-90. doi: 10.1097/01.brs.0000219940.26390.26.
citation: Rillardon L, Guigui P, Veil-Picard A, Slulittel H, Deburge A. [Long-term results of surgical treatment of lumbar spinal stenosis]. Rev Chir Orthop Reparatrice Appar Mot. 2003 Nov;89(7):621-31. French.
citation: Lieberman I. Surgery reduced pain and disability in lumbar spinal stenosis better than nonoperative treatment. J Bone Joint Surg Am. 2007 Aug;89(8):1872. doi: 10.2106/JBJS.8908.ebo2. No abstract available.