Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-03-16 @ 8:51 AM
Study NCT ID:
NCT01591967
Status:
COMPLETED
Last Update Posted:
2012-05-04
First Post:
2012-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-02', 'studyFirstSubmitDate': '2012-04-30', 'studyFirstSubmitQcDate': '2012-05-02', 'lastUpdatePostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The purpose of this randomized controlled trial (RCT) was to measure the effects of specific thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both normotensive and hypertensive humans.', 'timeFrame': 'Baseline, pre-adjustment, post-adjustment', 'description': 'OBJECTIVE: Previous studies on the effects of chiropractic treatment on blood pressure (BP) and pulse rate (PR) have reported decreases in both systolic and diastolic BP, as well as PR. However, many of those studies have been criticized for various study flaws, and accused of drawing erroneous conclusions, due to small sample size and various methodological concerns. The purpose of this randomized controlled trial (RCT) was to measure the effects of specific thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both normotensive and hypertensive humans.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chiropractic', 'Blood pressure', 'Pulse Rate', 'Thoracic'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized controlled trial (RCT) is to measure the effects of specific thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both normotensive and hypertensive humans.', 'detailedDescription': 'OBJECTIVE: Previous studies on the effects of chiropractic treatment on blood pressure (BP) and pulse rate (PR) have reported decreases in both systolic and diastolic BP, as well as PR. However, many of those studies have been criticized for various study flaws, and accused of drawing erroneous conclusions, due to small sample size and various methodological concerns. The purpose of this randomized controlled trial (RCT) is to measure the effects of specific thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both normotensive and hypertensive humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects were invited to participate in accordance with the Guidelines for Chiropractic Quality Assurance and Practice Parameters: proceedings of the Mercy Center Consensus Conference, Gaithersburg, MD, 1993, Aspen Publishers Inc.\n\nAdditionally and specifically for this RCT:\n\n1. Both male and female subjects age 18 years and older were invited to participate\n2. Subjects must not be pregnant\n3. Subjects must not have any recent or current fractures of the arms or legs\n4. Subjects must not have any visceral or abdominal condition such that being in the prone position would be detrimental to their health\n5. Subjects must not have any known primary cancers of the spine or spinal column, nor any secondary metastatic process of the spine or spinal column\n6. Subjects must not be under the influence of drugs or alcohol\n7. Subjects must not have vertigo or any other imbalance condition\n8. Subjects must not have any arm or leg prosthetic device\n9. Subjects must be able to understand spoken and/or written Spanish and/or English\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01591967', 'briefTitle': 'Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate', 'organization': {'class': 'OTHER', 'fullName': 'Spinal Missions, Inc., LLC'}, 'officialTitle': 'A Randomized Controlled Trial to Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate', 'orgStudyIdInfo': {'id': 'SM001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control -- no intervention'}, {'type': 'NO_INTERVENTION', 'label': 'Placebo w/ sham', 'description': 'Sham intervention with the adjusting tool turned "off"'}, {'type': 'EXPERIMENTAL', 'label': 'Activator treatment', 'description': 'Treatment with Activator', 'interventionNames': ['Device: Activator IV Adjusting Instrument']}], 'interventions': [{'name': 'Activator IV Adjusting Instrument', 'type': 'DEVICE', 'otherNames': ['Activator adjusting instrument', 'http://www.activator.com/products-page/'], 'description': 'Activator (http://www.activator.com/products-page/) adjustment effects on BP and PR', 'armGroupLabels': ['Activator treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Steven D. Roffers, DC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spinal Missions, Inc., LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spinal Missions, Inc., LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research', 'investigatorFullName': 'Dr. Steven D. Roffers', 'investigatorAffiliation': 'Spinal Missions, Inc., LLC'}}}}