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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Other: Control group (C); Other: Test group

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
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • University Hospital of Bordeaux - Hospital Pellegrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	the 90 days visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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),	Day 0
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),	Day 4
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),	Day 30
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),	Day 90
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),	Day 365
evaluation of the radicular pain	measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),	Day 0
evaluation of the radicular pain	measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),	Day 4
evaluation of the radicular pain	measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),	Day 30
evaluation of the radicular pain	measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),	Day 90
evaluation of the radicular pain	measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),	Day 365
evaluation scales	evaluation scales : score of Quebec (functional impotence)	Day 0
evaluation scales	evaluation scales : score of Quebec (functional impotence)	Day 4
evaluation scales	evaluation scales : score of Quebec (functional impotence)	Day 30
evaluation scales	evaluation scales : score of Quebec (functional impotence)	Day 90
evaluation scales	evaluation scales : score of Quebec (functional impotence)	Day 365
maximal walking distance	maximal walking distance : on a defined road	Day 0
maximal walking distance	maximal walking distance : on a defined road	Day 4
maximal walking distance	maximal walking distance : on a defined road	Day 30
maximal walking distance	maximal walking distance : on a defined road	Day 90
maximal walking distance	maximal walking distance : on a defined road	Day 365
compliance with the auto-reeducation at home	compliance with the auto-reeducation at home : questionnaire.	Day 30
compliance with the auto-reeducation at home	compliance with the auto-reeducation at home : questionnaire.	Day 90
compliance with the auto-reeducation at home	compliance with the auto-reeducation at home : questionnaire.	Day 365
Score of Japanese Orthopaedic Association (llumbar radiculopathy)		Day 4
Score of Japanese Orthopaedic Association (llumbar radiculopathy)		Day 30
Score of Japanese Orthopaedic Association (llumbar radiculopathy)		Day 90
Score of Japanese Orthopaedic Association (llumbar radiculopathy)		Day 365
score of "Douleur Neuropathique 4" (DN4 - neuropathy)		Day 4
score of "Douleur Neuropathique 4" (DN4 - neuropathy)		Day 30
score of "Douleur Neuropathique 4" (DN4 - neuropathy)		Day 90
score of "Douleur Neuropathique 4" (DN4 - neuropathy)		Day 365
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)		Day 4
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)		Day 30
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)		Day 90
score Medical Outcomes Study Short-Form General Health Survey 12 (health status)		Day 365

Collaborators and Investigators

• Sponsor: 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 and helpful links

General Publications

• 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.
• Berney J. [Epidemiology of narrow spinal canal]. Neurochirurgie. 1994;40(3):174-8. French.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: November 18, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: lumbar spinal stenosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: CHUBX 2012/36