Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-24 @ 3:13 PM
Study NCT ID:
NCT02883634
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2016-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Specific or Non-Specific Manipulation for Patients With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2016-08-25', 'studyFirstSubmitQcDate': '2016-08-25', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '4 weeks', 'description': 'Pain intensity will be measured using a 0-10 numerical rating scale'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '3 and 6 months after randomization', 'description': 'Pain intensity will be measured using a 0-10 numerical rating scale'}, {'measure': 'Disability', 'timeFrame': '4 weeks, 3 and 6 months after randomization', 'description': 'Disability will be measured by the 0-24 Roland Morris Disability Questionnaire'}, {'measure': 'Global Impression of Recovery', 'timeFrame': '4 weeks, 3 and 6 months after randomization', 'description': 'Global impression of recovery will be measured by an 11-item Global Perceived Effect Scale'}, {'measure': 'Pressure Pain Threshold', 'timeFrame': '4 weeks after randomization', 'description': 'Pressure Pain Threshold will be measure by a digital pressure algomoter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Back pain', 'spinal manipulation'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '32660919', 'type': 'DERIVED', 'citation': 'de Oliveira RF, Costa LOP, Nascimento LP, Rissato LL. Directed vertebral manipulation is not better than generic vertebral manipulation in patients with chronic low back pain: a randomised trial. J Physiother. 2020 Jul;66(3):174-179. doi: 10.1016/j.jphys.2020.06.007. Epub 2020 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'We aim to evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization.', 'detailedDescription': 'To evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization.\n\n148 patients with chronic non-specific low back pain will be enrolled for this clinical trial. Patients will undergo to a specific physical examination in order to determine the ideal lumbar spine level to be manipulated. The outcomes of interest are pain intensity, pain pressure threshold, global perceived effect and disability associated with back pain. After the first assessment patients will be randomly assigned to two groups that will receive 10 sessions of spinal manipulation over a period of four weeks, and may receive manipulation according to the findings on physical examination (specific manipulation) or may receive manipulation in the upper thoracic region, disregarding the physical examination findings (nonspecific manipulation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients with low back pain duration from 3 to 24 months.\n\nExclusion criteria:\n\n* Patients with a pain duration lower than 3 months and higher than 24 months.\n* Patients with nerve root compromise or with serious spinal pathology,\n* Pregnant patients,\n* Previous back surgery\n* Patients with any contra-indication to spinal manipulation.'}, 'identificationModule': {'nctId': 'NCT02883634', 'briefTitle': 'Specific or Non-Specific Manipulation for Patients With Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Cidade de Sao Paulo'}, 'officialTitle': 'Short, Medium and Long Term Effects of Specific and Nonspecific Spinal Manipulative Therapy in Patients With Chronic Non-specific Low Back Pain: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UNICID10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'specific manipulation', 'description': 'Participants allocated to group "specific manipulation", will have their lumbar spine manipulated according to the previous clinical examination.', 'interventionNames': ['Other: Specific manipulation']}, {'type': 'EXPERIMENTAL', 'label': 'non-specific manipulation', 'description': 'Participants allocated to group "non-specific manipulation" will have their upper thoracic spine manipulated (also known as "global manipulation") regardless of the previous clinical examination.', 'interventionNames': ['Other: Non-specific manipulation']}], 'interventions': [{'name': 'Specific manipulation', 'type': 'OTHER', 'description': 'Patients allocated to the specific manipulation group will receive spinal manipulation according to the physical examination performed prior to the treatment allocation.', 'armGroupLabels': ['specific manipulation']}, {'name': 'Non-specific manipulation', 'type': 'OTHER', 'description': 'Patients allocated to the specific manipulation group will receive spinal manipulation on the upper thoracic spine that will be not related to the physical examination performed prior to the treatment allocation.', 'armGroupLabels': ['non-specific manipulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03071-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Cidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Leonardo Costa, PT, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidade Cidade de São Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We are happy to share our data with researchers that would like to use it on an IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Cidade de Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Ronaldo Fernando de Oliveira', 'investigatorAffiliation': 'Universidade Cidade de Sao Paulo'}}}}