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

Primary Purpose

Lumbar Spinal Stenosis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Control group (C)
Test group
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lumbar Spinal Stenosis focused on measuring lumbar spinal stenosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of Bordeaux - Hospital Pellegrin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Control group (C)

Test group (M)

Arm Description

Kyphosis reeducation + patient education + auto-reeducation at home

Spinal mobility reeducation + patient education + auto-reeducation at home.

Outcomes

Primary Outcome Measures

maximal walking distance
: 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

evaluation of the lumbar pain
evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
evaluation of the lumbar pain
evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
evaluation of the lumbar pain
evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
evaluation of the lumbar pain
evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
evaluation of the lumbar pain
evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
evaluation of the radicular pain
measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
evaluation of the radicular pain
measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
evaluation of the radicular pain
measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
evaluation of the radicular pain
measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
evaluation of the radicular pain
measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
evaluation scales
evaluation scales : score of Quebec (functional impotence)
evaluation scales
evaluation scales : score of Quebec (functional impotence)
evaluation scales
evaluation scales : score of Quebec (functional impotence)
evaluation scales
evaluation scales : score of Quebec (functional impotence)
evaluation scales
evaluation scales : score of Quebec (functional impotence)
maximal walking distance
maximal walking distance : on a defined road
maximal walking distance
maximal walking distance : on a defined road
maximal walking distance
maximal walking distance : on a defined road
maximal walking distance
maximal walking distance : on a defined road
maximal walking distance
maximal walking distance : on a defined road
compliance with the auto-reeducation at home
compliance with the auto-reeducation at home : questionnaire.
compliance with the auto-reeducation at home
compliance with the auto-reeducation at home : questionnaire.
compliance with the auto-reeducation at home
compliance with the auto-reeducation at home : questionnaire.
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)

Full Information

First Posted
June 4, 2015
Last Updated
October 22, 2020
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT02610335
Brief Title
Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration
Acronym
CLEMOB
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
The recruitment of participants was very difficult despite a change in the organisation. The inclusion criteria did not result in the expected number of participants, and the credits ran out.
Study Start Date
January 15, 2016 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
Keywords
lumbar spinal stenosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group (C)
Arm Type
Active Comparator
Arm Description
Kyphosis reeducation + patient education + auto-reeducation at home
Arm Title
Test group (M)
Arm Type
Other
Arm Description
Spinal mobility reeducation + patient education + auto-reeducation at home.
Intervention Type
Other
Intervention Name(s)
Control group (C)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Test group
Intervention Description
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 Measure Information:
Title
maximal walking distance
Description
: 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).
Time Frame
the 90 days visit
Secondary Outcome Measure Information:
Title
evaluation of the lumbar pain
Description
evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Time Frame
Day 0
Title
evaluation of the lumbar pain
Description
evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Time Frame
Day 4
Title
evaluation of the lumbar pain
Description
evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Time Frame
Day 30
Title
evaluation of the lumbar pain
Description
evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Time Frame
Day 90
Title
evaluation of the lumbar pain
Description
evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Time Frame
Day 365
Title
evaluation of the radicular pain
Description
measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Time Frame
Day 0
Title
evaluation of the radicular pain
Description
measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Time Frame
Day 4
Title
evaluation of the radicular pain
Description
measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Time Frame
Day 30
Title
evaluation of the radicular pain
Description
measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Time Frame
Day 90
Title
evaluation of the radicular pain
Description
measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),
Time Frame
Day 365
Title
evaluation scales
Description
evaluation scales : score of Quebec (functional impotence)
Time Frame
Day 0
Title
evaluation scales
Description
evaluation scales : score of Quebec (functional impotence)
Time Frame
Day 4
Title
evaluation scales
Description
evaluation scales : score of Quebec (functional impotence)
Time Frame
Day 30
Title
evaluation scales
Description
evaluation scales : score of Quebec (functional impotence)
Time Frame
Day 90
Title
evaluation scales
Description
evaluation scales : score of Quebec (functional impotence)
Time Frame
Day 365
Title
maximal walking distance
Description
maximal walking distance : on a defined road
Time Frame
Day 0
Title
maximal walking distance
Description
maximal walking distance : on a defined road
Time Frame
Day 4
Title
maximal walking distance
Description
maximal walking distance : on a defined road
Time Frame
Day 30
Title
maximal walking distance
Description
maximal walking distance : on a defined road
Time Frame
Day 90
Title
maximal walking distance
Description
maximal walking distance : on a defined road
Time Frame
Day 365
Title
compliance with the auto-reeducation at home
Description
compliance with the auto-reeducation at home : questionnaire.
Time Frame
Day 30
Title
compliance with the auto-reeducation at home
Description
compliance with the auto-reeducation at home : questionnaire.
Time Frame
Day 90
Title
compliance with the auto-reeducation at home
Description
compliance with the auto-reeducation at home : questionnaire.
Time Frame
Day 365
Title
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
Time Frame
Day 4
Title
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
Time Frame
Day 30
Title
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
Time Frame
Day 90
Title
Score of Japanese Orthopaedic Association (llumbar radiculopathy)
Time Frame
Day 365
Title
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
Time Frame
Day 4
Title
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
Time Frame
Day 30
Title
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
Time Frame
Day 90
Title
score of "Douleur Neuropathique 4" (DN4 - neuropathy)
Time Frame
Day 365
Title
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
Time Frame
Day 4
Title
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
Time Frame
Day 30
Title
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
Time Frame
Day 90
Title
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)
Time Frame
Day 365

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu DE-SÈZE, MD
Organizational Affiliation
service de médecine physique et de réadaptation, Centre Hospitalier Universitaire de Bordeaux,
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Antoine BENARD, MD
Organizational Affiliation
USMR CHU Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Bordeaux - Hospital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
7723924
Citation
Berney J. [Epidemiology of narrow spinal canal]. Neurochirurgie. 1994;40(3):174-8. French.
Results Reference
background
PubMed Identifier
17538085
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.
Results Reference
background
PubMed Identifier
16741459
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.
Results Reference
background
PubMed Identifier
14699308
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.
Results Reference
background
PubMed Identifier
17671033
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.
Results Reference
background

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

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