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

Lumbar Spinal Stenosis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02610335
• Other study ID #: CHUBX 2012/36
• Status: Terminated
• Phase: N/A
• Start date: January 15, 2016
• Est. completion date: June 1, 2018

Study information

• Verified date: October 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

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
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.

Locations

Country	Name	City	State
France	University Hospital of Bordeaux - Hospital Pellegrin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (5)

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

Outcome

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