Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-05 @ 11:00 AM
Study NCT ID:
NCT05132894
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2021-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Osteopathic Assessment of Lower Extremity Somatic Dysfunction in Runners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-02', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2021-11-12', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Structural exam to determine type of Lower Extremity Somatic Dysfunctions in participants', 'timeFrame': 'up to 8 weeks', 'description': 'Osteopathic Structural Exam to assess changes to muscles, bones, bursae, and ligaments'}, {'measure': "Questionnaire to analyze data on runners' background/history", 'timeFrame': 'up to 8 weeks', 'description': "Questionnaire to learn about runners' background"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['somatic dysfunction', 'runners', 'osteopathic', 'osteopathic assessment', 'lower extremity', 'lower extremity somatic dysfunction', 'running injury'], 'conditions': ['Somatic Dysfunction of Sacral Region', 'Somatic Dysfunction of Both Sacroiliac Joints', 'Somatic Dysfunction of Bilateral Lower Extremities']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.practiceupdate.com/content/amount-of-running-and-association-with-risk-of-all-cause-cardiovascular-and-cancer-mortality/92176/37/6/1?elsca1=TrendMD_CPA&origin=b3610ec5cf201fa8306d1680c13278de', 'label': 'Amount of Running and Association With Risk of All-Cause, Cardiovascular, and Cancer Mortality'}, {'url': 'https://bjsm.bmj.com/content/early/2019/09/25/bjsports-2018-100493', 'label': 'Is running associated with a lower risk of all-cause, cardiovascular and cancer mortality, and is the more the better? A systematic review and meta-analysis'}, {'url': 'https://doi.org/10.1186/s12891-019-2898-0', 'label': 'Controlled trial to compare the Achilles tendon load during running in flatfeet participants using a customized arch support orthoses vs an orthotic heel lift.'}, {'url': 'https://journals.lww.com/acsm-essr/Abstract/2019/10000/Overuse_Injury__The_Result_of_Pathologically.6.aspx', 'label': 'Overuse Injury: The Result of Pathologically Altered Myofascial Force Transmission?'}, {'url': 'https://europepmc.org/article/MED/28236094', 'label': 'Diseases and overuse injuries of the lower extremities in long distance runners'}, {'url': 'https://link.springer.com/article/10.1007/s40279-015-0333-8', 'label': 'Incidence of Running-Related Injuries Per 1000 h of running in Different Types of Runners: A Systematic Review and Meta-Analysis'}, {'url': 'https://link.springer.com/article/10.2165/00007256-199213010-00005', 'label': 'Lower Extremity Injuries in Runners'}]}, 'descriptionModule': {'briefSummary': 'Runners often experience acute/chronic pain due to pre-existing structural somatic dysfunction and/or acquired various overuse injuries of the lower extremity, specifically affecting the ligaments, tendons, muscles and bones. Common structural and function dysfunctions include but are not limited to patellofemoral pain syndrome (PFPS), Achilles tendonitis, iliotibial band syndrome (ITBS), ligamentous and muscle tears, muscle sprains/strains, stress fractures, pes planus, plantar fasciitis, and shin splints.\n\nThe purpose of this study is to assess the correlation between acute and chronic pain, overuse injuries, and observational and palpatory findings upon evaluation. With an understanding of the common trends of somatic dysfunctions and etiology of the pain/injury, modified regimen/routine and improved treatment plans can be developed and recommended for runners to better rehabilitate, minimize relapse and reduce compensatory injuries. No medical or osteopathic treatment will be provided.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes any adult-aged males and females that are self-proclaimed runners confirming that they run at least 1 mile per week. The runners will be categorized based on the quantity of miles run weekly.\n\nThe sampling method is non-probability for convenience to easily gather data.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-proclaimed runners that run at least 1 mile per week consistently\n* Minimum 18 years old\n\nExclusion Criteria:\n\n* Non-runners\n* Inconsistent runners, do not log at least 1 mile weekly'}, 'identificationModule': {'nctId': 'NCT05132894', 'briefTitle': 'An Osteopathic Assessment of Lower Extremity Somatic Dysfunction in Runners', 'organization': {'class': 'OTHER', 'fullName': 'The Touro College and University System'}, 'officialTitle': 'An Osteopathic Assessment of Lower Extremity Somatic Dysfunction in Runners', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Novice Runners', 'description': '1-5 miles / week 18+ yo', 'interventionNames': ['Other: Osteopathic Assessment']}, {'label': 'Moderate Runners', 'description': '6-15 miles / week 18+ yo', 'interventionNames': ['Other: Osteopathic Assessment']}, {'label': 'Advanced Runners', 'description': '16+ miles / week 18+ yo', 'interventionNames': ['Other: Osteopathic Assessment']}], 'interventions': [{'name': 'Osteopathic Assessment', 'type': 'OTHER', 'description': 'As osteopathic structural exam will be performed to assessment somatic dysfunctions of the lower extremities.', 'armGroupLabels': ['Advanced Runners', 'Moderate Runners', 'Novice Runners']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10027', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Touro College of Osteopathic Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Touro College and University System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, OMS-IV', 'investigatorFullName': 'Abbey Santanello', 'investigatorAffiliation': 'The Touro College and University System'}}}}