Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-28 @ 9:31 AM
Study NCT ID:
NCT03722394
Status:
COMPLETED
Last Update Posted:
2018-10-26
First Post:
2018-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Neuroscience Education for Acute and Sub-Acute Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Observational cohort'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-24', 'studyFirstSubmitDate': '2018-10-22', 'studyFirstSubmitQcDate': '2018-10-24', 'lastUpdatePostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NPRS - LBP', 'timeFrame': 'Immediate change from baseline after assigned intervention', 'description': 'Numeric Pain Rating Scale for Low Back Pain (Range 0 = no pain to 11 = maximum pain)'}, {'measure': 'NPRS - Leg pain', 'timeFrame': 'Immediate change from baseline after assigned intervention', 'description': 'Numeric Pain Rating Scale for leg pain (Range 0 = no pain to 11 = maximum pain)'}], 'secondaryOutcomes': [{'measure': 'Active trunk flexion', 'timeFrame': 'Immediate change from baseline in centimeters after assigned intervention', 'description': 'Active trunk flexion measured in centimeters from fingertips to floor'}, {'measure': 'Passive Straight Leg Raise', 'timeFrame': 'Immediate change from baseline in angular degrees after assigned intervention', 'description': 'Range of hip flexion angle during passive straight leg raise test measured in degrees'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain', 'Pain, Chronic', 'Pain, Back']}, 'descriptionModule': {'briefSummary': 'To determine if Pain Neuroscience Education (PNE) would result in positive clinical changes in patients presenting with acute or sub-acute low back pain (LBP).', 'detailedDescription': 'Background: Pain neuroscience education (PNE) has shown efficacy in treating chronic pain. Clinicians may believe PNE is not suitable for acute and sub-acute pain. Subgroupings of low back pain (LBP) imply some patients with LBP may respond favorably to PNE.\n\nObjective: To determine if PNE would result in positive clinical changes in patients presenting with acute or sub-acute LBP.\n\nMethods: Eighty consecutive patients with LBP \\< 3 months were enrolled in the study. Patients completed a demographics questionnaire, leg and LBP rating (Numeric Pain Rating Scale - NPRS), disability (Oswestry Disability Index), fear-avoidance (Fear-Avoidance Beliefs Questionnaire), pain catastrophization (Pain Catastrophization Scale), central sensitization (Central Sensitization Inventory), pain knowledge (Revised Neurophysiology of Pain Questionnaire), risk assessment (Keele STarT Back Screening Tool), active trunk flexion and straight leg raise (SLR). Patients received a 15-minute verbal, one-on-one PNE session, followed by repeat measurement of LBP and leg pain (NPRS), trunk flexion and SLR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a complaint of LBP with or without leg pain less than 3 months, and\n* a willingness to participate\n\nExclusion Criteria:\n\n* a) were under age 18 (minor);\n* b) had undergone lumbar surgery;\n* c) could not read or understand the English language;\n* d) presented with any cognitive deficits rendering them unsuitable for PNE (i.e., stroke, traumatic brain injury, etc.),\n* e) declined to participate or\n* f) presented with a medical etiology (red flag) associated with their LBP.'}, 'identificationModule': {'nctId': 'NCT03722394', 'briefTitle': 'Pain Neuroscience Education for Acute and Sub-Acute Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Nevada, Las Vegas'}, 'officialTitle': 'Pain Neuroscience Education for Acute and Sub-Acute Low Back Pain: An Exploratory Case Series', 'orgStudyIdInfo': {'id': '1202-4022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain Neuroscience Education', 'description': 'Subjects received a 15-minute verbal, one-on-one Pain Neuroscience Education (PNE) session', 'interventionNames': ['Behavioral: Pain Neuroscience Education']}], 'interventions': [{'name': 'Pain Neuroscience Education', 'type': 'BEHAVIORAL', 'description': '15 minute verbal one-on-one education session', 'armGroupLabels': ['Pain Neuroscience Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89178', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'University of Nevada Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'overallOfficials': [{'name': 'Kevin Farrell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Ambrose University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nevada, Las Vegas', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Ambrose University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project Coordinator', 'investigatorFullName': 'Emilio J Puentedura, PT, DPT, PhD', 'investigatorAffiliation': 'University of Nevada, Las Vegas'}}}}