Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-25 @ 6:56 PM
Study NCT ID:
NCT03892759
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2019-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteopathic Manipulative Treatment for Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D002637', 'term': 'Chest 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': 'D026301', 'term': 'Manipulation, Osteopathic'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pre/post prospective one group pilot study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2019-03-22', 'studyFirstSubmitQcDate': '2019-03-25', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Functional Status at 8 weeks', 'timeFrame': '8 weeks', 'description': 'Functional Status as measured by Roland-Morris Disability Questionnaire. Question responses are totaled for a score of 0 to 24 with higher number indicating a worse outcome or greater level of disability.'}, {'measure': 'Change from Baseline Functional Status at 12 weeks', 'timeFrame': '12 weeks', 'description': 'Functional Status as measured by Roland-Morris Disability Questionnaire. Question responses are totaled for a score of 0 to 24 with higher number indicating a worse outcome or greater level of disability.'}, {'measure': 'Change from Baseline Back Range of Motion at 3 weeks', 'timeFrame': '3 Weeks', 'description': 'Range of Motion a measured by Back Range of Motion (BROM) Instrument'}, {'measure': 'Change from Baseline Back Range of Motion at 8 weeks', 'timeFrame': '8 weeks', 'description': 'Range of Motion a measured by Back Range of Motion (BROM) Instrument'}, {'measure': 'Change from Baseline Back Pain at 3 weeks', 'timeFrame': '3 weeks', 'description': 'Pain as measured by Visual Analog Scale (VAS). The scale indicates a level of pain from 0 to 10 with higher number associated with a worse outcome or greater level of pain.'}, {'measure': 'Change from Baseline Back Pain at 8 weeks', 'timeFrame': '8 weeks', 'description': 'Pain as measured by Visual Analog Scale (VAS). The scale indicates a level of pain from 0 to 10 with higher number associated with a worse outcome or greater level of pain.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Assessment of Quality of Life at 8 weeks', 'timeFrame': '8 weeks', 'description': 'Quality of Life as measured by PROMIS Global Health Questionnaire. Total Physical Health Score of 7 to 17 with lower numbers indicating better physical health outcome and Total Mental Health Score of 8 to 16 with lower numbers indicating better mental health outcome.'}, {'measure': 'Change from Baseline Assessment of Quality of Life at 12 weeks', 'timeFrame': '12 weeks', 'description': 'Quality of Life as measured by PROMIS Global Health Questionnaire. Total Physical Health Score of 7 to 17 with lower numbers indicating better physical health outcome and Total Mental Health Score of 8 to 16 with lower numbers indicating better mental health outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteopathic Manipulative Treatment'], 'conditions': ['Back Pain', 'Lumbar Pain', 'Thoracic Pain', 'Somatic Dysfunction', 'Fascial Distortion']}, 'descriptionModule': {'briefSummary': 'This study will investigate if Osteopathic Manipulative Treatment (OMT) is beneficial for patients presenting with back pain.', 'detailedDescription': 'Low back pain is the most common cause of disability in people under age 45 and accounts for 20% of all physician visits. Osteopathic manual treatment (OMT) has been used to manage patients with acute and chronic back pain. These treatments are often reported as beneficial by patients.\n\nThis study will examine the effect on functional status, range of motion, quality of life, and pain with Osteopathic Manipulative Treatment (OMT). Baseline will be defined as someone who has never had OMT, chiropractic, or massage, or has not received such treatments in the last 90 days. Back pain will be specific to pain presenting in the lumbar or thoracic regions of the spine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult 18 years of age or older\n* Back pain\n* Able to arrange transportation and arrive to three study appointments.\n\nExclusion Criteria:\n\n* May not have had manual treatment (massage, chiropractic, or OMT) in the last 90 days\n* May not have any labs or imaging for their back pain recommended by their physicians the subject has not yet completed\n* May not have had back surgery in past 60 days\n* May not be pregnant or have given birth in the last 30 days\n* May not have be unable to tell a member of the study team their name, city they live in and the current year.'}, 'identificationModule': {'nctId': 'NCT03892759', 'briefTitle': 'Osteopathic Manipulative Treatment for Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Pacific Northwest University of Health Sciences'}, 'officialTitle': 'Osteopathic Manipulative Treatment for Back Pain: Evaluation of Short Term Changes in Functional Status, Quality of Life, and Pain', 'orgStudyIdInfo': {'id': '2019-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Evaluation and Treatment', 'description': 'Subjects will be evaluated through inspection and palpation of the thoracic and lumbar spine, and other body regions as necessary. The provider will make a diagnosis of somatic dysfunction based off the TART (tissue texture change, asymmetry, restriction of motion, tenderness/pain) findings.', 'interventionNames': ['Other: Osteopathic Manipulative Therapy']}], 'interventions': [{'name': 'Osteopathic Manipulative Therapy', 'type': 'OTHER', 'description': 'A set of hands-on techniques used by Osteopathic Physicians for the assessment and treatment of somatic dysfunction.', 'armGroupLabels': ['Evaluation and Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98901', 'city': 'Yakima', 'state': 'Washington', 'country': 'United States', 'facility': 'Pacific Northwest University of Health Sciences', 'geoPoint': {'lat': 46.60207, 'lon': -120.5059}}], 'overallOfficials': [{'name': 'Crystal Martin, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor of Osteopathic Principles and Practice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pacific Northwest University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Crystal Martin', 'investigatorAffiliation': 'Pacific Northwest University of Health Sciences'}}}}