Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration
NCT ID: NCT02610335
Last Updated: 2020-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
23 participants
INTERVENTIONAL
2016-01-15
2018-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control group (C)
Kyphosis reeducation + patient education + auto-reeducation at home
Control group (C)
* kyphosis reeducation on Huber platform during 2 weeks,
* patient education : on physiopathology of the lumbar spinal stenosis and treatments as well as healthy lifestyle and prevention (plans of anatomy, plastic column, slides of medical imaging),
* flexibility exercises, stretching exercises and abdominal muscles exercises : to continue at home (the exercises will be reported on a book that will be given to the patient),
* exercises on cycle ergometer or walking on treadmill : to continue at home.
Test group (M)
Spinal mobility reeducation + patient education + auto-reeducation at home.
Test group
* spinal mobility reeducation on Huber platform during 2 weeks,
* patient education : on physiopathology of the lumbar spinal stenosis and treatments as well as healthy lifestyle and prevention (plans of anatomy, plastic column, slides of medical imaging),
* flexibility exercises and mobilization exercises : to continue at home (the exercises will be reported on a book that will be given to the patient),
* exercises on cycle ergometer or walking on treadmill : to continue at home.
Interventions
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Control group (C)
* kyphosis reeducation on Huber platform during 2 weeks,
* patient education : on physiopathology of the lumbar spinal stenosis and treatments as well as healthy lifestyle and prevention (plans of anatomy, plastic column, slides of medical imaging),
* flexibility exercises, stretching exercises and abdominal muscles exercises : to continue at home (the exercises will be reported on a book that will be given to the patient),
* exercises on cycle ergometer or walking on treadmill : to continue at home.
Test group
* spinal mobility reeducation on Huber platform during 2 weeks,
* patient education : on physiopathology of the lumbar spinal stenosis and treatments as well as healthy lifestyle and prevention (plans of anatomy, plastic column, slides of medical imaging),
* flexibility exercises and mobilization exercises : to continue at home (the exercises will be reported on a book that will be given to the patient),
* exercises on cycle ergometer or walking on treadmill : to continue at home.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Mathieu DE-SÈZE, MD
Role: STUDY_DIRECTOR
service de médecine physique et de réadaptation, Centre Hospitalier Universitaire de Bordeaux,
Antoine BENARD, MD
Role: STUDY_CHAIR
USMR CHU Bordeaux
Locations
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University Hospital of Bordeaux - Hospital Pellegrin
Bordeaux, , France
Countries
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References
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Berney J. [Epidemiology of narrow spinal canal]. Neurochirurgie. 1994;40(3):174-8. French.
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.
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.
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.
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.
Other Identifiers
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CHUBX 2012/36
Identifier Type: -
Identifier Source: org_study_id