Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-02 @ 11:04 PM
Study NCT ID:
NCT02276794
Status:
TERMINATED
Last Update Posted:
2017-02-16
First Post:
2014-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020393', 'term': 'Manipulation, Spinal'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000529', 'term': 'Complementary Therapies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'Time and funding constraints', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2014-10-22', 'studyFirstSubmitQcDate': '2014-10-27', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Foot contact area', 'timeFrame': 'Up to 10 minutes after intervention', 'description': 'Foot contact area will be measured by a digital baropodometer (FootWork Pro)'}], 'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Up to 10 minutes after intervention', 'description': 'Pain will me measured Up to 10 minutes after intervention by an 11 point (0-11) Numeric Pain Rating Scale (NPRS)'}], 'secondaryOutcomes': [{'measure': 'Global Perceived Effect', 'timeFrame': 'Up to 10 minutes after intervention', 'description': 'Global Perceived effect will be measured by an 11 point (-5-+5) Global Perceived Effect (GPE)'}, {'measure': 'Lumbar joint position sense', 'timeFrame': 'Up to 10 minutes after intervention', 'description': 'Lumbar joint position sense will be measured by a isokinetic dynamometer (BIODEX System 4 Pro™, Shirley, NY)'}, {'measure': 'Peak plantar pressure', 'timeFrame': 'Up to 10 minutes after intervention', 'description': 'Peak plantar pressure will be measured by a digital baropodometer (FootWork Pro)'}, {'measure': 'Center of Pressure displacement', 'timeFrame': 'Up to 10 minutes after intervention', 'description': 'CoP displacement will be measured by a digital baropodometer (FootWork Pro) by means of stabilometry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Low back pain', 'Thrust manipulation', 'Spinal manipulation', 'Joint mobilization', 'Non-thrust manipulation', 'proprioception', 'Postural stability', 'Baropodometry'], 'conditions': ['Low Back Pain', 'Mechanical Low Back Pain', 'Backache']}, 'descriptionModule': {'briefSummary': 'This study aims to verify the effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain.', 'detailedDescription': 'Forty individuals with chronic low back pain will be randomly assigned, by a researcher not involved in data collection, to two treatment groups: Thrust manipulation (side-lying rotational manipulation standardized to the L4-L5 level) or non-thrust manipulation (side-lying grade III rotational non-thrust manipulation). A single treatment session will be provided.\n\nOutcome measurement will be conducted immediately after the treatment session. Data will be collected by a blinded assessor. Between-group differences will be calculated by constructing mixed linear models following an intention-to-treat principle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than 18 years\n* Chronic Low back pain (pain lasting for at least 12 weeks)\n* NPRS ≥ 3\n\nExclusion Criteria:\n\n* Previous surgery or fracture at the lumbar spine\n* Pregnancy\n* Inflammatory disorders\n* Symptoms distal to the gluteal line\n* Having received manipulative treatment in the past four weeks'}, 'identificationModule': {'nctId': 'NCT02276794', 'briefTitle': 'Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Health Science of Porto Alegre'}, 'officialTitle': 'The Effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain', 'orgStudyIdInfo': {'id': '19051513.5.0000.5345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thrust manipulation (TM)', 'description': 'The patients allocated to the TM group will receive TM aimed at the L4-L5 intervertebral segments. All the patients will be positioned in a standardized position (right side-lying) and will receive a rotational TM technique. The treating therapist will have up to two attempts to perform the TM in each patient.\n\nThere is no need for cavitation in order to consider the TM successful; the occurence of cavitation, however, will be recorded.\n\nA single treatment will be provided.', 'interventionNames': ['Other: Thrust Manipulation']}, {'type': 'EXPERIMENTAL', 'label': 'Non-thrust manipulation (NTM)', 'description': 'The patients allocated to the NTM group will receive TM aimed at the L4-L5 intervertebral segments. All the patients will be positioned in a standardized position (right side-lying) and will receive 30 oscilations of a grade III rotational NTM.\n\nA single treatment will be provided', 'interventionNames': ['Other: Non-thrust manipulation (NTM)']}], 'interventions': [{'name': 'Thrust Manipulation', 'type': 'OTHER', 'otherNames': ['Spinal manipulation', 'Lumbar manipulation', 'Lumbar thrust', 'Manual Therapy', 'Manipulative therapy'], 'description': 'After positioning patients in right side-lying, a rotational TM technique will be addressed at the L4-L5 lumbar segments. The treating therapist will have up to two attempts to apply the TM.', 'armGroupLabels': ['Thrust manipulation (TM)']}, {'name': 'Non-thrust manipulation (NTM)', 'type': 'OTHER', 'otherNames': ['Mobilization', 'Joint mobilization', 'lumbar mobilization', 'Manual therapy', 'Maitland'], 'description': 'A grade III rotational non-thrust manipulation will be addressed at the L4-L5 lumbar segments. Thirty oscilations will be performed.', 'armGroupLabels': ['Non-thrust manipulation (NTM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90050-170', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Federal University of Health Sciences of Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Marcelo F Silva, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Adjunct professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Health Science of Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT', 'investigatorFullName': 'Giovanni Esteves Ferreira', 'investigatorAffiliation': 'Federal University of Health Science of Porto Alegre'}}}}