Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-12 @ 10:07 PM
Study NCT ID:
NCT02387567
Status:
COMPLETED
Last Update Posted:
2015-03-13
First Post:
2014-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paraspinal Block in Nonspecific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 378}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-12', 'studyFirstSubmitDate': '2014-05-22', 'studyFirstSubmitQcDate': '2015-03-12', 'lastUpdatePostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse effects questionnaire', 'timeFrame': 'Immediately after intervention and 3 months post application'}], 'primaryOutcomes': [{'measure': 'Change from baseline in pain on the visual analog scale (VAS) score for pain at week 1', 'timeFrame': 'Baseline, week 1'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in pain on the Brazilian Roland-Morris tool at week 1', 'timeFrame': 'Baseline, week 1'}, {'measure': 'Change from baseline in pain on the Brazilian Roland-Morris tool at week 12', 'timeFrame': 'baseline, week 12'}, {'measure': 'Change from baseline in pain on the visual analog scale (VAS) score for pain', 'timeFrame': 'Baseline, week 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '26828801', 'type': 'DERIVED', 'citation': 'Imamura M, Imamura ST, Targino RA, Morales-Quezada L, Onoda Tomikawa LC, Onoda Tomikawa LG, Alfieri FM, Filippo TR, da Rocha ID, Neto RB, Fregni F, Battistella LR. Paraspinous Lidocaine Injection for Chronic Nonspecific Low Back Pain: A Randomized Controlled Clinical Trial. J Pain. 2016 May;17(5):569-76. doi: 10.1016/j.jpain.2016.01.469. Epub 2016 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of a treatment involving the application of lidocaine injected on the low back area for pain control. The study will compare this form of treatment with other options such as physical exercises or pain killer medication, different measurements are going to be used to quantify the response to each of these treatments.', 'detailedDescription': 'This trial was conducted in the Department of Rehabilitation, Hospital das Clinicas, University, of Sao Paulo Medical School, one of the largest rehabilitation centers in Brazil. The trial was initiated in January of 2007 and close to enrollment in January of 2013. Investigators included patients with a diagnosis of chronic nonspecific low back pain who were referred from various clinics in São Paulo that were linked to this rehabilitation center. Thus, patients were referred primarily by physiatrists, general practitioners, neurologists, orthopedic surgeons, and physiotherapists.\n\nParticipants were randomized to receive: (i) paraspinal lidocaine injection (LID-INJ) and standard treatment, (ii) sham lidocaine injection (SH-INJ) and standard treatment, or (iii) standard treatment only (STD-TTR). Randomization was performed using a computerized random number generator.\n\nAssessments The evaluations were performed by an independent and blinded appraiser before treatment, after 1 week, and 3 months after the end of the applications. Baseline assessments consisted of a demographic and baseline clinical assessment \\[gender, age, occupation, duration of pain (months), pain intensity, associated diseases, and usual occupation\\] and a physical examination \\[measurements of weight and height to calculate body mass index (BMI)\\].\n\nPrimary Outcome Measure The primary outcome measure was the visual analog scale (VAS) score for pain. The VAS comprised a 10-cm ruler from 0 to 10, with 0 corresponding to no pain and 10 corresponding to maximum pain. Patients were asked to rate their average pain in the preceding 24 hs.\n\nSecondary Outcome Measures Investigators also measured low back pain using the Brazilian Roland-Morris tool, which consisted of a specific questionnaire to assess function in patients with low back pain and has been validated in Brazil. Scores range from 0 to 24, wherein higher scores reflect greater disability due to low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age between 20 to 60 years;\n* Clinical symptoms of vertebral pain that is unresponsive to symptomatic treatment with anti-inflammatory drugs for 3 months;\n* Moderate to severe pain: visual analog scale (VAS) \\> 4;\n* Diagnosis of chronic nonspecific low back pain;\n* MiniMental test (MEEM) between 24 and 30;\n* Availability to comply with the visits;\n* Agree with signing the Informed Consent Form\n\nExclusion criteria:\n\n* Severe psychiatric disease that requires psychiatric care;\n* Neurological disorders (lumbosciatic pain);\n* Concurrent fibromyalgia, per the 1990 diagnostic criteria of the American Academy of Rheumatology\n* Concurrent rheumatic disease\n* History of allergy to lidocaine (used for paraspinal blocks)\n* Labor problems\n* History of surgery on the lumbar spine\n* No availability to visit the clinic for treatment and evaluations.'}, 'identificationModule': {'nctId': 'NCT02387567', 'briefTitle': 'Paraspinal Block in Nonspecific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Study on the Effects of Paraspinal Lidocaine Injection on Nonspecific Low Back Pain', 'orgStudyIdInfo': {'id': 'PS-block-Pain'}, 'secondaryIdInfos': [{'id': 'U1111-1155-7609', 'type': 'OTHER', 'domain': 'WHO-UTN U1111-1155-7609'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine', 'description': 'Paraspinal infusion of 3ml lidocaine at 1%, once a week for three weeks, combined with standard treatment.', 'interventionNames': ['Drug: Lidocaine', 'Other: Standard treatment']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham lidocaine', 'description': 'Sham Injection, without lidocaine, combined with standard treatment.', 'interventionNames': ['Drug: Sham Lidocaine', 'Other: Standard treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment only', 'description': 'The only intervention is the standard treatment. No lidocaine or shame injection was used.', 'interventionNames': ['Other: Standard treatment']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['3ml lidocaine 1% Injection'], 'description': 'Paraspinal block with 3ml lidocaine injection at 1%.', 'armGroupLabels': ['Lidocaine']}, {'name': 'Sham Lidocaine', 'type': 'DRUG', 'otherNames': ['3ml sham injection'], 'description': 'Sham injection, without lidocaine.', 'armGroupLabels': ['Sham lidocaine']}, {'name': 'Standard treatment', 'type': 'OTHER', 'otherNames': ['Lowback pain standard treatment'], 'description': 'Standard treatment only, without lidocaine or sham injection.', 'armGroupLabels': ['Lidocaine', 'Sham lidocaine', 'Standard treatment only']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Marta Imamura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Medicina Física e Reabilitação HCFMUSP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marta Imamura', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': '1. Head of Technical Section of Physical and Rehabilitation Medicine of the Orthopedics and Traumatology Institute of HC FMUSP, Coordinator of the Center for Physical and Rehabilitation Medicine of HC FMUSP', 'investigatorFullName': 'Marta Imamura', 'investigatorAffiliation': 'University of Sao Paulo'}}}}