Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT02982369
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2016-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck 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': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-25', 'studyFirstSubmitDate': '2016-11-28', 'studyFirstSubmitQcDate': '2016-12-01', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '4 weeks after randomization', 'description': 'Intensity of pain will be measured by the numeric pain rating scale (NPRS)'}], 'secondaryOutcomes': [{'measure': 'Cytokines', 'timeFrame': '4 weeks after randomization', 'description': 'Level of concentration of pro and anti-inflammatory cytokines'}, {'measure': 'Pressure Pain Threshold', 'timeFrame': '4 weeks and 3 months after randomization', 'description': 'Pressure pain Threshold will be measured with a digital algometer'}, {'measure': 'Disability', 'timeFrame': '4 weeks and 3 months after randomization', 'description': 'Disability will be measured by the Neck Disability Index (NDI)'}, {'measure': 'Fear Avoidance Beliefs', 'timeFrame': '4 weeks and 3 months after randomization', 'description': 'Fear Avoidance will be measured by the Fear Avoidance Beliefs Questionnaire (FABQ)'}, {'measure': 'Health-related Quality of Life', 'timeFrame': '4 weeks and 3 months after randomization', 'description': 'Quality of Life will be measured by the 12-Item Health Survey (SF-12)'}, {'measure': 'Kinesiophobia', 'timeFrame': '4 weeks and 3 months after randomization', 'description': 'Kinesiophobia will be measured byTampa Scale for Kinesiophobia'}, {'measure': 'Pain Intensity', 'timeFrame': '3 months after randomization', 'description': 'Intensity of pain will be measured by the numeric pain rating scale (NPRS)'}]}, 'conditionsModule': {'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effects of vertebral manipulation and pain education on subjects with neck pain. For this purpose, 90 subjects who present chronic neck pain will be selected and allocated randomly into 2 groups: vertebral manipulation group and pain education group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Main complaint of Neck Pain for at least six (6) months;\n* Score of at least 10 points in NDI (Neck Disability Index);\n* Pain and / or restriction of cervical movements;\n* Pain reported at least 3 points on the NPRS (Numeric Pain Rating Scale);\n* The definition of the term Neck Pain follows the classification of TFNP.\n\nExclusion Criteria:\n\n* Previous history of rheumatic disease, cervical myelopathy, tumors, vertebrobasilar insufficiency, central or peripheral neurological disorders;\n* History of major trauma, fracture or surgery in the neck, shoulder and/or upper limb;\n* Signs of nerve root compression as important muscle weakness affecting the upper limbs, reduction, loss or increase of biceps and triceps reflexes, decreased sensation in the dermatomes of the upper limb;\n* Red flags contraindicating spinal manipulation.'}, 'identificationModule': {'nctId': 'NCT02982369', 'briefTitle': 'The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Santa Catarina Federal University'}, 'officialTitle': 'The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain', 'orgStudyIdInfo': {'id': 'MBracht'}, 'secondaryIdInfos': [{'id': 'U1111-1190-4280', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spinal Manipulation', 'description': 'High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region and pain education.\n\nThe subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes.', 'interventionNames': ['Other: Spinal Manipulation', 'Other: Pain Education']}, {'type': 'SHAM_COMPARATOR', 'label': 'Pain Education', 'description': 'Pain education and a simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.\n\nThe subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes.', 'interventionNames': ['Other: Pain Education', 'Other: Sham']}], 'interventions': [{'name': 'Spinal Manipulation', 'type': 'OTHER', 'otherNames': ['Vertebral Manipulation'], 'description': 'High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region', 'armGroupLabels': ['Spinal Manipulation']}, {'name': 'Pain Education', 'type': 'OTHER', 'otherNames': ['Pain Neuroscience Education'], 'description': 'Subjects will receive pain education based in biopsychosocial approach', 'armGroupLabels': ['Pain Education', 'Spinal Manipulation']}, {'name': 'Sham', 'type': 'OTHER', 'description': 'A simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.', 'armGroupLabels': ['Pain Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88040-900', 'city': 'Florianópolis', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Santa Catarina Federal University', 'geoPoint': {'lat': -27.59667, 'lon': -48.54917}}], 'overallOfficials': [{'name': 'Adair R Soares dos Santos, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Santa Catarina Federal University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santa Catarina Federal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marcelo Anderson Bracht', 'investigatorAffiliation': 'Santa Catarina Federal University'}}}}