Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-03 @ 4:29 AM
Study NCT ID:
NCT03181802
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2017-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain (LBP)?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This study was a randomized, double-blinded, placebo-controlled phase 3 trial comparing Intramuscular injections of botulinum toxin A to a placebo in patients with chronic low-back pain (LBP)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2005-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-08', 'studyFirstSubmitDate': '2017-05-29', 'studyFirstSubmitQcDate': '2017-06-08', 'lastUpdatePostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2005-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect of paravertebral injections of BoNT-A, 30 days after its administration in chronic LBP sufferers.', 'timeFrame': 'Day 30', 'description': 'Pain intensity was measured on a horizontal visual analogue scale (VAS) 100 mm long, with " no pain " written on one end and " maximum pain " on the other. The question asked was: "How was the intensity of your LBP over the last 8 days?"'}], 'secondaryOutcomes': [{'measure': 'Evaluate the analgesic effect of paravertebral injections of BoNT-A, 90 days after its administration in chronic LBP sufferers.', 'timeFrame': 'Day 90', 'description': 'Initial pain was detailed as follows: Immediate average LBP was recorded on VAS at the first injection'}, {'measure': 'Measure the impact of paravertebral injections of 200 IU of BoNT-A in a single administration on lumbar stiffness and on spinal extensor muscle strength in patients with chronic LBP.', 'timeFrame': 'Day 30', 'description': 'Lumbar pain intensity was measured on a horizontal visual analogue scale 100 mm long, with " no pain " written on one end and "maximum pain" on the other. The question asked was: "How was the intensity of your LBP over the last 8 days?" The question asked was: "How was the intensity of your LBP over the last 8 days?"'}, {'measure': 'Measure the impact of paravertebral injections of 200 IU of BoNT-A in a single administration on lumbar stiffness and on spinal extensor muscle strength in patients with chronic LBP.', 'timeFrame': 'Day 120', 'description': 'Lumbar pain intensity was measured on a horizontal visual analogue scale 100 mm long, with " no pain " written on one end and "maximum pain" on the other. The question asked was: "How was the intensity of your LBP over the last 8 days?" The question asked was: "How was the intensity of your LBP over the last 8 days?"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Low-back Pain']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Foster et al., 2001 and Machado et al., 2016'}, {'pmid': '29141611', 'type': 'DERIVED', 'citation': 'Cogne M, Petit H, Creuze A, Liguoro D, de Seze M. Are paraspinous intramuscular injections of botulinum toxin a (BoNT-A) efficient in the treatment of chronic low-back pain? A randomised, double-blinded crossover trial. BMC Musculoskelet Disord. 2017 Nov 15;18(1):454. doi: 10.1186/s12891-017-1816-6.'}], 'seeAlsoLinks': [{'url': 'http://www.cebm.net/wp-content/uploads/2014/06/CEBM-Levels-of-Evidence-2.1.pdf', 'label': 'Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence'}]}, 'descriptionModule': {'briefSummary': 'Studying the therapeutic effect of paravertebral injections of BoNT-A (botulinum toxin A) requires further studies to confirm the reported short-term therapeutic effect and to determine potential predictive factors of efficacy.', 'detailedDescription': 'This study was a randomized, double-blinded, placebo-controlled phase 3 trial comparing BoNT-A Type A injections to a placebo in patients with chronic Low-back Pain (LBP). This superiority trial obtained support from the French Hospital Clinical Research Project (PHRC) and the approval of a French ethics committee (2003/02) ("Comité Sud-Ouest et Outre-Mer III", consent obtained in February 2003).\n\nThe number of participants included in the study was chosen to be similar as those included in previous studies, that showed a strong positive effect of BoNT-A injections on LBP. Furthermore, the design of our study (i.e. a crossover) increased the power of the statistical analysis. A scientific committee has been solicited at this step, after including 19 patients, to assess the results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LBP defined as a pain located between the thoracic lumbar hinge and the gluteal sulcus, where pain had evolved over a period of 6 months despite well conducted medical treatment, self-assessed lumbar pain intensity over 50 millimeters long on a visual analogue scale of 100 millimeters (0=no pain; 100=maximal pain),\n* having been on sick leave for 60 or more days in the year preceding the inclusion (in order to include patients with high consequences of chronic low-back pain on their work),\n* same long-term chronic pain treatment for at least 6 weeks\n\nExclusion Criteria:\n\n* age under 18 or over 55 years (to avoid secondary causes of low back pain, like spinal tumor),\n* ongoing pregnancy or breast-feeding,\n* a neuromuscular pathology (myasthenia gravis, amyotrophic lateral sclerosis, myopathy, polymyositis), aminoglycoside treatment at the time of inclusion,\n* skin infection at injection points,\n* diabetes and alcoholism (in order to avoid other etiologies of chronic pain),\n* a history of injecting BoNT-A A,\n* anticoagulation treatment, sciatica,\n* suspected spinal inflammatory disorder (spondylitis, inflammatory rheumatism, tumoral pathology),\n* a failed back surgery syndrome (when surgery failed to relieve low-back pain), - incapacity to stand, cardiorespiratory deficiency which does not allow the isokinetic exploration of the spinal muscles,\n* cognitive disorders limiting patient participation,\n* conflicts of interest owing to existing pain (unconsolidated work accident, ongoing damage compensation).\n* Spine infection, tumour or trauma had been specifically excluded by an MRI done by all patients before the inclusion in the present study.\n* No patient was allowed to take opiates during the time of the study,\n* facet joint injections were also not permitted during the study period.'}, 'identificationModule': {'nctId': 'NCT03181802', 'acronym': 'BoNT-A', 'briefTitle': 'Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain (LBP)?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain?', 'orgStudyIdInfo': {'id': 'CHUBX2003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'botulinum toxin A', 'interventionNames': ['Drug: Botox']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Botox', 'type': 'DRUG', 'description': 'single injection of 200 International Unit of BoNT-A in 10 bilateral paravertebral intramuscular points for treating chronic LBP', 'armGroupLabels': ['botulinum toxin A']}, {'name': 'Placebos', 'type': 'DRUG', 'description': '4 ml of physiological serum injected intramuscularly into the lumbar paravertebral muscles.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Bordeaux University Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Matthieu DE SEZE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}