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

NCT02610335 | Terminated

• 1 other identifier: CHUBX 2012/36
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis

Keywords

lumbar spinal stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (35)

• evaluation of the lumbar pain

  Day 0

• evaluation of the lumbar pain

  Day 4

• evaluation of the lumbar pain

  Day 30

• evaluation of the lumbar pain

  Day 90

• evaluation of the lumbar pain

  Day 365

Study Arms (2)

Control group (C)

ACTIVE COMPARATOR

Kyphosis reeducation + patient education + auto-reeducation at home

Other: Control group (C)

Test group (M)

OTHER

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

Other: Test group

Interventions

Control group (C) OTHER

* 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.

Control group (C)

Test group OTHER

* 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.

Test group (M)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Hospital of Bordeaux - Hospital Pellegrin

Bordeaux, 33000, France

Location

Related Publications (5)

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

  PMID: 7723924 BACKGROUND

• 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.

  PMID: 17538085 BACKGROUND

• 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.

  PMID: 16741459 BACKGROUND

• 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.

  PMID: 14699308 BACKGROUND

• 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.

  PMID: 17671033 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mathieu DE-SÈZE, MD

  service de médecine physique et de réadaptation, Centre Hospitalier Universitaire de Bordeaux,

  STUDY DIRECTOR

• Antoine BENARD, MD

  USMR CHU Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: November 20, 2015
• Study Start: January 15, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 26, 2020

Record last verified: 2020-10

Locations

FR (1)