Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-09 @ 12:41 PM
Study NCT ID:
NCT02610335
Status:
TERMINATED
Last Update Posted:
2020-10-26
First Post:
2015-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': '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.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-22', 'studyFirstSubmitDate': '2015-06-04', 'studyFirstSubmitQcDate': '2015-11-18', 'lastUpdatePostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximal walking distance', 'timeFrame': 'the 90 days visit', '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).'}], 'secondaryOutcomes': [{'measure': 'evaluation of the lumbar pain', 'timeFrame': 'Day 0', 'description': 'evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),'}, {'measure': 'evaluation of the lumbar pain', 'timeFrame': 'Day 4', 'description': 'evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),'}, {'measure': 'evaluation of the lumbar pain', 'timeFrame': 'Day 30', 'description': 'evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),'}, {'measure': 'evaluation of the lumbar pain', 'timeFrame': 'Day 90', 'description': 'evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),'}, {'measure': 'evaluation of the lumbar pain', 'timeFrame': 'Day 365', 'description': 'evaluation of the lumbar pain: measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),'}, {'measure': 'evaluation of the radicular pain', 'timeFrame': 'Day 0', 'description': 'measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),'}, {'measure': 'evaluation of the radicular pain', 'timeFrame': 'Day 4', 'description': 'measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),'}, {'measure': 'evaluation of the radicular pain', 'timeFrame': 'Day 30', 'description': 'measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),'}, {'measure': 'evaluation of the radicular pain', 'timeFrame': 'Day 90', 'description': 'measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),'}, {'measure': 'evaluation of the radicular pain', 'timeFrame': 'Day 365', 'description': 'measured by a verbal analog scale 0-100 mm (0 : no pain, 100 : maximal pain),'}, {'measure': 'evaluation scales', 'timeFrame': 'Day 0', 'description': 'evaluation scales : score of Quebec (functional impotence)'}, {'measure': 'evaluation scales', 'timeFrame': 'Day 4', 'description': 'evaluation scales : score of Quebec (functional impotence)'}, {'measure': 'evaluation scales', 'timeFrame': 'Day 30', 'description': 'evaluation scales : score of Quebec (functional impotence)'}, {'measure': 'evaluation scales', 'timeFrame': 'Day 90', 'description': 'evaluation scales : score of Quebec (functional impotence)'}, {'measure': 'evaluation scales', 'timeFrame': 'Day 365', 'description': 'evaluation scales : score of Quebec (functional impotence)'}, {'measure': 'maximal walking distance', 'timeFrame': 'Day 0', 'description': 'maximal walking distance : on a defined road'}, {'measure': 'maximal walking distance', 'timeFrame': 'Day 4', 'description': 'maximal walking distance : on a defined road'}, {'measure': 'maximal walking distance', 'timeFrame': 'Day 30', 'description': 'maximal walking distance : on a defined road'}, {'measure': 'maximal walking distance', 'timeFrame': 'Day 90', 'description': 'maximal walking distance : on a defined road'}, {'measure': 'maximal walking distance', 'timeFrame': 'Day 365', 'description': 'maximal walking distance : on a defined road'}, {'measure': 'compliance with the auto-reeducation at home', 'timeFrame': 'Day 30', 'description': 'compliance with the auto-reeducation at home : questionnaire.'}, {'measure': 'compliance with the auto-reeducation at home', 'timeFrame': 'Day 90', 'description': 'compliance with the auto-reeducation at home : questionnaire.'}, {'measure': 'compliance with the auto-reeducation at home', 'timeFrame': 'Day 365', 'description': 'compliance with the auto-reeducation at home : questionnaire.'}, {'measure': 'Score of Japanese Orthopaedic Association (llumbar radiculopathy)', 'timeFrame': 'Day 4'}, {'measure': 'Score of Japanese Orthopaedic Association (llumbar radiculopathy)', 'timeFrame': 'Day 30'}, {'measure': 'Score of Japanese Orthopaedic Association (llumbar radiculopathy)', 'timeFrame': 'Day 90'}, {'measure': 'Score of Japanese Orthopaedic Association (llumbar radiculopathy)', 'timeFrame': 'Day 365'}, {'measure': 'score of "Douleur Neuropathique 4" (DN4 - neuropathy)', 'timeFrame': 'Day 4'}, {'measure': 'score of "Douleur Neuropathique 4" (DN4 - neuropathy)', 'timeFrame': 'Day 30'}, {'measure': 'score of "Douleur Neuropathique 4" (DN4 - neuropathy)', 'timeFrame': 'Day 90'}, {'measure': 'score of "Douleur Neuropathique 4" (DN4 - neuropathy)', 'timeFrame': 'Day 365'}, {'measure': 'score Medical Outcomes Study Short-Form General Health Survey 12 (health status)', 'timeFrame': 'Day 4'}, {'measure': 'score Medical Outcomes Study Short-Form General Health Survey 12 (health status)', 'timeFrame': 'Day 30'}, {'measure': 'score Medical Outcomes Study Short-Form General Health Survey 12 (health status)', 'timeFrame': 'Day 90'}, {'measure': 'score Medical Outcomes Study Short-Form General Health Survey 12 (health status)', 'timeFrame': 'Day 365'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lumbar spinal stenosis'], 'conditions': ['Lumbar Spinal Stenosis']}, 'referencesModule': {'references': [{'pmid': '7723924', 'type': 'BACKGROUND', 'citation': 'Berney J. [Epidemiology of narrow spinal canal]. Neurochirurgie. 1994;40(3):174-8. French.'}, {'pmid': '17538085', 'type': 'BACKGROUND', '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.'}, {'pmid': '16741459', 'type': 'BACKGROUND', '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.'}, {'pmid': '14699308', 'type': 'BACKGROUND', '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.'}, {'pmid': '17671033', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nYet 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 :\n\n* group C (control group) : kyphosis reeducation + patient education + auto-reeducation at home,\n* group M (test group) : spinal mobility reeducation + patient education + auto-reeducation at home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 50 years,\n* central, acquired and multi-staged lumbar spinal stenosis,\n* pain since at least three months,\n* radicular pains higher than the lumbar pains,\n* walking distance \\< 1000 m,\n* oral consent.\n\nExclusion Criteria:\n\n* intercurrent pathology limiting the walking distance (arteriopathy, cardio-respiratory insufficiency, disabling arthrosis affecting the lower limbs...),\n* history of spinal surgery for lumbar spinal stenosis,\n* extended lumbar arthrodesis (equal to or greater than 2 levels),\n* monosegmental and degenerative spondylolisthesis,\n* foraminal stenosis,\n* 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),\n* bleeding disorders or allergies contraindicating the epidural infiltration.'}, 'identificationModule': {'nctId': 'NCT02610335', 'acronym': 'CLEMOB', 'briefTitle': 'Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CHUBX 2012/36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group (C)', 'description': 'Kyphosis reeducation + patient education + auto-reeducation at home', 'interventionNames': ['Other: Control group (C)']}, {'type': 'OTHER', 'label': 'Test group (M)', 'description': 'Spinal mobility reeducation + patient education + auto-reeducation at home.', 'interventionNames': ['Other: Test group']}], 'interventions': [{'name': 'Control group (C)', 'type': 'OTHER', 'description': '* kyphosis reeducation on Huber platform during 2 weeks,\n* 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),\n* 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),\n* exercises on cycle ergometer or walking on treadmill : to continue at home.', 'armGroupLabels': ['Control group (C)']}, {'name': 'Test group', 'type': 'OTHER', 'description': '* spinal mobility reeducation on Huber platform during 2 weeks,\n* 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),\n* flexibility exercises and mobilization exercises : to continue at home (the exercises will be reported on a book that will be given to the patient),\n* exercises on cycle ergometer or walking on treadmill : to continue at home.', 'armGroupLabels': ['Test group (M)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'University Hospital of Bordeaux - Hospital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Mathieu DE-SÈZE, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'service de médecine physique et de réadaptation, Centre Hospitalier Universitaire de Bordeaux,'}, {'name': 'Antoine BENARD, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'USMR CHU Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}