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

U

University Hospital of Bordeaux

Status

Terminated

Conditions

Lumbar Spinal Stenosis

Treatments

Other: Test group
Other: Control group (C)

Study type

Interventional

Funder types

Other

Identifiers

NCT02610335
CHUBX 2012/36

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

All

Ages

50+ years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

23 participants in 2 patient groups

Control group (C)
Active Comparator group
Description:
Kyphosis reeducation + patient education + auto-reeducation at home
Treatment:
Other: Control group (C)
Test group (M)
Other group
Description:
Spinal mobility reeducation + patient education + auto-reeducation at home.
Treatment:
Other: Test group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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