Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-03 @ 9:20 AM
Study NCT ID:
NCT00298935
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2006-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-21', 'studyFirstSubmitDate': '2006-03-02', 'studyFirstSubmitQcDate': '2006-03-02', 'lastUpdatePostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale for pain, Roland-Morris Disability Questionnaire, and SF-12 Health Status Survey during third trimester of pregnancy and continuing six weeks post-partum'}], 'secondaryOutcomes': [{'measure': 'Occurrence of premature labor and delivery as well as obstetrical complications during delivery'}]}, 'conditionsModule': {'keywords': ['Randomized Controlled Trial', 'Pregnant Women'], 'conditions': ['Low Back Pain', 'Musculoskeletal Diseases', 'Pregnancy Complications']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether osteopathic manipulative treatment (OMT):\n\n* decreases pain and improves physical functioning in women during the third trimester of pregnancy\n* decreases complications during obstetrical delivery\n* improves quality of life in the post-partum period', 'detailedDescription': 'Women experience multiple changes in their anatomy and physiology during pregnancy that may cause pain and adversely affect quality of life. Additionally, about ten percent of women will experience signs and symptoms of pre-eclampsia or pre-term labor during their first pregnancy.\n\nPreliminary studies of osteopathic manipulative treatment (OMT) have demonstrated a decrease in pain during pregnancy, although the mechanisms responsible for this effect are unclear.\n\nAnother theory is that osteopathic manipulative treatment (OMT) may help normalize sympathetic outflow, thereby minimizing pregnancy complications. A recently published retrospective study also suggests that pregnant women receiving osteopathic manipulative treatment (OMT) may be at lower risk for pre-term delivery and the presence of meconium during delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Third trimester pregnancy\n\nExclusion Criteria:\n\n* High risk pregnancy\n* Previous use of chiropractic manipulation, osteopathic manipulative treatment (OMT), physical therapy, or therapeutic ultrasound during the current pregnancy'}, 'identificationModule': {'nctId': 'NCT00298935', 'briefTitle': 'Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'University of North Texas Health Science Center'}, 'officialTitle': 'Pilot Clinical Trial of Osteopathic Manipulative Treatment (OMT) in Pregnancy', 'orgStudyIdInfo': {'id': '20-102'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Osteopathic manipulative treatment (OMT)', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76107', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Osteopathic Research Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'John C. Licciardone, D.O., M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osteopathic Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Texas Health Science Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Osteopathic Heritage Foundations', 'class': 'OTHER'}]}}}