Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-03-07 @ 11:47 PM
Study NCT ID:
NCT02027168
Status:
TERMINATED
Last Update Posted:
2015-01-26
First Post:
2014-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-22', 'studyFirstSubmitDate': '2014-01-02', 'studyFirstSubmitQcDate': '2014-01-02', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in endocrine levels post treatment', 'timeFrame': 'baseline, pre-treatment and 30 and 60 days post treatment', 'description': 'Change in FSH, LH and estradiol levels from baseline and pre-treatment, baseline and 30 and 60 day post treatment.'}], 'secondaryOutcomes': [{'measure': 'Pain levels and sexual function before treatment', 'timeFrame': '30 days before treatment', 'description': 'Pain levels and sexual function before treatment as compared to baseline.'}, {'measure': 'Pain levels and sexual function post treatment', 'timeFrame': '30 days post treatment', 'description': 'Pain levels and sexual function as measured by survey 30 days post treatment compared to baseline.'}, {'measure': 'Pain levels and sexual function post treatment', 'timeFrame': '60 days post treatment', 'description': 'Pain levels and sexual function as measured by survey 60 days post treatment compared to baseline.'}, {'measure': 'Pregnancy', 'timeFrame': 'study duration; 60 days post treatment', 'description': 'Subjects will be monitored for natural intrauterine pregnancy for the duration of the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infertility', 'elevated FSH', 'alternative treatment', 'Clear Passage Approach', 'Clear Passage Physical Therapy'], 'conditions': ['FSH Hypersecretion', 'Endocrine System Diseases', 'Infertility']}, 'referencesModule': {'references': [{'pmid': '18251317', 'type': 'BACKGROUND', 'citation': 'Wurn BF, Wurn LJ, King CR, Heuer MA, Roscow AS, Hornberger K, Scharf ES. Treating fallopian tube occlusion with a manual pelvic physical therapy. Altern Ther Health Med. 2008 Jan-Feb;14(1):18-23.'}, {'pmid': '15775874', 'type': 'BACKGROUND', 'citation': 'Wurn LJ, Wurn BF, King CR, Roscow AS, Scharf ES, Shuster JJ. Increasing orgasm and decreasing dyspareunia by a manual physical therapy technique. MedGenMed. 2004 Dec 14;6(4):47.'}, {'pmid': '15266276', 'type': 'BACKGROUND', 'citation': 'Wurn BF, Wurn LJ, King CR, Heuer MA, Roscow AS, Scharf ES, Shuster JJ. Treating female infertility and improving IVF pregnancy rates with a manual physical therapy technique. MedGenMed. 2004 Jun 18;6(2):51.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine the impact of manual physical therapy on endocrine function in women diagnosed as being infertile due to elevated follicle stimulating hormone (FSH) levels (10 mIU/mL or higher) on days 2-5 of their menstrual cycle. It is hypothesized that the manual physical therapy will decrease FSH levels.', 'detailedDescription': 'This study will investigate the effect of manual physical therapy on the endocrine levels of women by comparison of pre- and post- treatment hormone levels (FSH, LH and Estradiol). Secondary measures include assessment of pain and sexual function via questionnaires.\n\nHormones will be measured at prescribed time points:\n\n* baseline: 30-60 days before treatment\n* pre-treatment: 7-30 days before treatment\n* post treatment 1: 10-30 days post treatment\n* post treatment 2: 30-60 days post treatment\n\nPain and sexual function questionnaires will be completed:\n\n* baseline: 30-60 days before treatment\n* pre-treatment: 7-30 days before treatment\n* post treatment 1: 30 days post treatment\n* post treatment 2: 60 days post treatment'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with elevated FSH levels that undergo the CPA treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed as infertile\n* FSH greater than 10mIU/mL on days 2-5 of menstrual cycle\n* Regular menstrual cycle\n* Residing in the US, accessible to a LabCorp testing facility\n\nExclusion Criteria:\n\n* Active infection including HIV or inflammation\n* Cancer within the past 5 years\n* Currently pregnant\n* Hemophilia, abnormal bleeding or clotting disorder\n* Immune system disorder\n* Abnormal ovarian cyst or endometrioma\n* BMI of 35 or greater\n* Any other condition in which deep manual physical therapy is contraindicated\n* Currently taking any fertility medications or planning to take any fertility related medications during the course of the study. This includes all ovarian stimulating medications, artificial hormones and birth control medications.\n* Participation in any assisted reproductive technique (such as IVF) other than intra-uterine insemination during the course of the study.'}, 'identificationModule': {'nctId': 'NCT02027168', 'briefTitle': 'Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clear Passage Therapies, Inc'}, 'officialTitle': 'Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women', 'orgStudyIdInfo': {'id': 'FSH-2012-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CPA treatment', 'description': 'CPA treatment group receives 20 hours of patient centered manual physical therapy', 'interventionNames': ['Other: CPA']}], 'interventions': [{'name': 'CPA', 'type': 'OTHER', 'otherNames': ['Clear Passage Approach', 'Wurn Technique'], 'description': 'Site specific, patient centered manual physical therapy regimen focused on restoring function to the entire body', 'armGroupLabels': ['CPA treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32606', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Clear Passage Physical Therapy', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Lawrence J Wurn, LMT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clear Passage Physical Therapy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clear Passage Therapies, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}