Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-01 @ 1:50 AM
Study NCT ID:
NCT01884818
Status:
COMPLETED
Last Update Posted:
2017-08-21
First Post:
2013-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracic Spine Manipulation for Patients With Thoracic Spine Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-16', 'studyFirstSubmitDate': '2013-02-25', 'studyFirstSubmitQcDate': '2013-06-21', 'lastUpdatePostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Work absent', 'timeFrame': 'Baseline, after treatment, 3, 8 and 49 week follow-up'}], 'primaryOutcomes': [{'measure': 'Thoracic spine pain (Visual analogue scale)', 'timeFrame': 'up to 49 week follow-up'}], 'secondaryOutcomes': [{'measure': 'Thoracic spine mobility (computer controllod spine PA measurement, tape measurements, inclinometer)', 'timeFrame': 'Baseline, after treatment, 3, 8, and 49 week follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thoracic spine, pain, manipulation'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '32778081', 'type': 'DERIVED', 'citation': 'Takatalo J, Ylinen J, Pienimaki T, Hakkinen A. Intra- and inter-rater reliability of thoracic spine mobility and posture assessments in subjects with thoracic spine pain. BMC Musculoskelet Disord. 2020 Aug 10;21(1):529. doi: 10.1186/s12891-020-03551-4.'}]}, 'descriptionModule': {'briefSummary': 'The study includes two phases. In phase one the reliability of thoracic spine mobility measurements are studied in subjects with thoracic spine pain. In phase two the reliable measurements are used to measure the effects of thoracic spine manipulation in subjects with thoracic spine pain. The changes in pain is measured as well.\n\nIn second phase the control group receives TNS treatment six times at home as a placebo so that the power of TNS is limited to very low level. The number of treatments are controlled as well as the time of treatment. The treatment group receives six manipulation treatments within 3 week period. The effects are measured immediately after the treatment weeks, and 3 and 8 week follow-up. Moreover the one year follow-up will be performed by mail questionnaire.', 'detailedDescription': 'Outcome measures are intensity of pain (VAS, Roland-Morris questionnaire) thoracic mobility (measured with computer, tape measurements, inclinometer and manually).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thoracic spine pain,\n* 18-55 years old\n\nExclusion Criteria:\n\n* Inflammatory spine disease,\n* previous surgery on thoracic spine area,\n* osteoporosis'}, 'identificationModule': {'nctId': 'NCT01884818', 'briefTitle': 'Thoracic Spine Manipulation for Patients With Thoracic Spine Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Jyvaskyla'}, 'officialTitle': 'The Effect of Manipulation for Thoracic Spine Pain and Mobility, and Reliability of Used Mobility Measurements.', 'orgStudyIdInfo': {'id': 'Thoracic'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manipulation', 'description': 'Subjects will receive 6 manipulation treatments within 3 weeks period. The manipulated segments are determined individually in baseline assessment.', 'interventionNames': ['Other: Manipulation vs. TNS thoracic pain']}, {'type': 'SHAM_COMPARATOR', 'label': 'TNS for thoracic spine', 'description': '6 TNS treatments at home for 20min in limited power of devices in three weeks period.', 'interventionNames': ['Other: Manipulation vs. TNS thoracic pain']}], 'interventions': [{'name': 'Manipulation vs. TNS thoracic pain', 'type': 'OTHER', 'armGroupLabels': ['Manipulation', 'TNS for thoracic spine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oulu', 'country': 'Finland', 'facility': 'Fysioteekki', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Jani Takatalo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Jyvaskyla'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jyvaskyla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project expert', 'investigatorFullName': 'Jtakatalo', 'investigatorAffiliation': 'University of Jyvaskyla'}}}}