Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-17 @ 9:45 PM
Study NCT ID:
NCT01438203
Status:
COMPLETED
Last Update Posted:
2012-09-05
First Post:
2011-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thrust Manipulation Versus Non-Thrust Manipulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C083180', 'term': 'Mob protein, Bacteria'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-31', 'studyFirstSubmitDate': '2011-09-19', 'studyFirstSubmitQcDate': '2011-09-20', 'lastUpdatePostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry disability index', 'timeFrame': 'Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.', 'description': 'Change score'}], 'secondaryOutcomes': [{'measure': 'Numeric Pain Rating Scale (NPRS)', 'timeFrame': 'Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.', 'description': 'Change score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['manipulation', 'mobilization', 'low back pain', 'treatment'], 'conditions': ['Mechanical Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '22879443', 'type': 'DERIVED', 'citation': "Cook CE, Learman KE, O'Halloran BJ, Showalter CR, Kabbaz VJ, Goode AP, Wright AA. Which prognostic factors for low back pain are generic predictors of outcome across a range of recovery domains? Phys Ther. 2013 Jan;93(1):32-40. doi: 10.2522/ptj.20120216. Epub 2012 Aug 9."}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the comparative benefit of thrust and non-thrust manipulation on a population of patients with low back pain. The investigators hypothesize that there will be no difference in 4 week outcomes or greater, between the two groups.', 'detailedDescription': 'Thrust manipulation is considered traditional spinal manipulation. Nonthrust manipulation is considered mobilization. The mobilization will be used in a similar manner as in clinical practice and this differs from past studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients, age 18 and older, with mechanically producible low back pain, who attend care at a physical therapy outpatient setting, will be screened for eligibility for the study.\n* For patients to meet inclusion requirements, they had to display a within session change in pain and/or range of motion during the assessment phase of the clinical examination. In other words, as the clinician performed their assessment and applied a passive accessory assessment technique, the pain and/or range of motion improved during that session, which suggests a favorable outcome using a comparable treatment technique. This is hallmark clinical finding in the patient response model and has been proposed as both a predictor of a positive outcome and as a prognostic variable toward long-term improvements in impairments.\n\nExclusion Criteria:\n\n* The presence of any red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)\n* Signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°\n* Muscle weakness involving a major muscle group of the lower extremity,\n* Diminished lower extremity muscle stretch reflex\n* Diminished or absent sensation to pinprick in any lower extremity dermatome)\n* Other exclusion criteria included prior surgery to the lumbar spine and current pregnancy'}, 'identificationModule': {'nctId': 'NCT01438203', 'briefTitle': 'Thrust Manipulation Versus Non-Thrust Manipulation', 'organization': {'class': 'OTHER', 'fullName': 'Walsh University'}, 'officialTitle': 'Early Use of Thrust Manipulation Versus Non-Thrust Manipulation: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Walsh 10-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thrust manipulation', 'description': 'Clinicians will use thrust manipulation at a targeted level to provide the treatment on selected individuals', 'interventionNames': ['Procedure: Thrust manipulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-thrust manipulation', 'description': 'Clinicians will apply non-thrust manipulation (targeted) as performed in a clinical manner for treatment for included individuals', 'interventionNames': ['Procedure: Non-thrust manipulation']}], 'interventions': [{'name': 'Thrust manipulation', 'type': 'PROCEDURE', 'otherNames': ['Manipualtion (Manip)'], 'description': 'Thrust manipulation is a passive procedure which involves a high velocity low amplitude thrust to the spinal region', 'armGroupLabels': ['Thrust manipulation']}, {'name': 'Non-thrust manipulation', 'type': 'PROCEDURE', 'otherNames': ['Mobilization (Mob)'], 'description': 'Non-thrust manipulation involves a low amplitude, low speed mobilization to the targeted region while adjusting the procedure based on patient feedback', 'armGroupLabels': ['Non-thrust manipulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44720', 'city': 'North Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Walsh University', 'geoPoint': {'lat': 40.87589, 'lon': -81.40234}}], 'overallOfficials': [{'name': 'Chad E Cook, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Walsh University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walsh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Chad Cook', 'investigatorAffiliation': 'Walsh University'}}}}