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Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration (CLEMOB)

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ClinicalTrials.gov Identifier: NCT02610335
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Other: Control group (C) Other: Test group Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : January 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Active Comparator: Control group (C)
Kyphosis reeducation + patient education + auto-reeducation at home
Other: 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.
Other: 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.




Primary Outcome Measures :
  1. maximal walking distance [ Time Frame: 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 :
  1. evaluation of the lumbar pain [ Time Frame: Day 0 ]
    evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),

  2. evaluation of the lumbar pain [ Time Frame: Day 4 ]
    evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),

  3. evaluation of the lumbar pain [ Time Frame: Day 30 ]
    evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),

  4. evaluation of the lumbar pain [ Time Frame: Day 90 ]
    evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),

  5. evaluation of the lumbar pain [ Time Frame: Day 365 ]
    evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),

  6. evaluation of the radicular pain [ Time Frame: Day 0 ]
    measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),

  7. evaluation of the radicular pain [ Time Frame: Day 4 ]
    measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),

  8. evaluation of the radicular pain [ Time Frame: Day 30 ]
    measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),

  9. evaluation of the radicular pain [ Time Frame: Day 90 ]
    measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),

  10. evaluation of the radicular pain [ Time Frame: Day 365 ]
    measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),

  11. evaluation scales [ Time Frame: Day 0 ]
    evaluation scales : score of Quebec (functional impotence)

  12. evaluation scales [ Time Frame: Day 4 ]
    evaluation scales : score of Quebec (functional impotence)

  13. evaluation scales [ Time Frame: Day 30 ]
    evaluation scales : score of Quebec (functional impotence)

  14. evaluation scales [ Time Frame: Day 90 ]
    evaluation scales : score of Quebec (functional impotence)

  15. evaluation scales [ Time Frame: Day 365 ]
    evaluation scales : score of Quebec (functional impotence)

  16. maximal walking distance [ Time Frame: Day 0 ]
    maximal walking distance : on a defined road

  17. maximal walking distance [ Time Frame: Day 4 ]
    maximal walking distance : on a defined road

  18. maximal walking distance [ Time Frame: Day 30 ]
    maximal walking distance : on a defined road

  19. maximal walking distance [ Time Frame: Day 90 ]
    maximal walking distance : on a defined road

  20. maximal walking distance [ Time Frame: Day 365 ]
    maximal walking distance : on a defined road

  21. compliance with the auto-reeducation at home [ Time Frame: Day 30 ]
    compliance with the auto-reeducation at home : questionnaire.

  22. compliance with the auto-reeducation at home [ Time Frame: Day 90 ]
    compliance with the auto-reeducation at home : questionnaire.

  23. compliance with the auto-reeducation at home [ Time Frame: Day 365 ]
    compliance with the auto-reeducation at home : questionnaire.

  24. Score of Japanese Orthopaedic Association (llumbar radiculopathy) [ Time Frame: Day 4 ]
  25. Score of Japanese Orthopaedic Association (llumbar radiculopathy) [ Time Frame: Day 30 ]
  26. Score of Japanese Orthopaedic Association (llumbar radiculopathy) [ Time Frame: Day 90 ]
  27. Score of Japanese Orthopaedic Association (llumbar radiculopathy) [ Time Frame: Day 365 ]
  28. score of "Douleur Neuropathique 4" (DN4 - neuropathy) [ Time Frame: Day 4 ]
  29. score of "Douleur Neuropathique 4" (DN4 - neuropathy) [ Time Frame: Day 30 ]
  30. score of "Douleur Neuropathique 4" (DN4 - neuropathy) [ Time Frame: Day 90 ]
  31. score of "Douleur Neuropathique 4" (DN4 - neuropathy) [ Time Frame: Day 365 ]
  32. score Medical Outcomes Study Short-Form General Health Survey 12 (health status) [ Time Frame: Day 4 ]
  33. score Medical Outcomes Study Short-Form General Health Survey 12 (health status) [ Time Frame: Day 30 ]
  34. score Medical Outcomes Study Short-Form General Health Survey 12 (health status) [ Time Frame: Day 90 ]
  35. score Medical Outcomes Study Short-Form General Health Survey 12 (health status) [ Time Frame: Day 365 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610335


Contacts
Contact: Audrey GIGNOL 05 56 79 56 79 ext 14522 audrey.gignol@chu-bordeaux.fr

Locations
France
University Hospital of Bordeaux - Hospital Pellegrin Recruiting
Bordeaux, France, 33000
Contact: Agnes GIGNOL    +335 56 79 56 79    audrey.gignol@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Study Director: Mathieu DE-SÈZE, MD service de médecine physique et de réadaptation, Centre Hospitalier Universitaire de Bordeaux,
Study Chair: Antoine BENARD, MD USMR CHU Bordeaux

Publications:
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02610335     History of Changes
Other Study ID Numbers: CHUBX 2012/36
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by University Hospital, Bordeaux:
lumbar spinal stenosis

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases