Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-04 @ 5:58 AM
Study NCT ID:
NCT02430857
Status:
UNKNOWN
Last Update Posted:
2015-05-19
First Post:
2015-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteopathy and Latent Hypothyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-17', 'studyFirstSubmitDate': '2015-04-27', 'studyFirstSubmitQcDate': '2015-04-27', 'lastUpdatePostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in TSH Concentration', 'timeFrame': '5 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Latent Hypothyroidism']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of stimulating the neurological segments c8-th5 in patients with latent hypothyroidism.\n\nOne half of the participants will receive an osteopathic manuel treatment in order to stimulate the relevant segments, the other half will receive no treatment.', 'detailedDescription': 'Patients with latent hypothyroidism show an increased hormone status in TSH and a normal hormone status in fT4. A study has shown that osteopathic treatment had positive effects to some symptoms in patients with latent hypothyroidism. The study was using the pain inventory as the instrument to measure the effect. In this study we want to evaluate the effectiveness of the treatment on the hormone status (TSH, fT4) The intervention group will receive a neurological osteopathic stimulation over 5 weeks. A parallel control group will not receive any therapy.\n\nA follow up blood screening (TSH, fT4) will be done. The results of both groups will be compared.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* latent hypothyroidism\n\nExclusion Criteria:\n\n* Factors that Alter Thyroxine and Triiodothyronine Binding in Serum\n* Increased thyroxin-binding globulin\n* Decreased thyroxin-binding globulin\n* Binding inhibitors\n* Inherited Salicylates\n* Pregnancy\n* Androgens\n* Furosemide\n* Neonatal state\n* Anabolic steroids\n* Free fatty acids\n* Estrogens\n* Glucocorticoids\n* Phenytoin\n* Hepatitis\n* Severe illness\n* Carbamazepine\n* Porphyria\n* Hepatic failure\n* nonsteroidal antiinflammatory drug (variable, transient)\n* Heroin\n* Nephrosis\n* Heparin\n* Methadone\n* Nicotinic acid\n* Mitotane L-Asparaginase\n* 5-Fluorouracil\n* SERMS (e.g., tamoxifen, raloxifene)\n* Perphenazine\n* spinal pathologies'}, 'identificationModule': {'nctId': 'NCT02430857', 'briefTitle': 'Osteopathy and Latent Hypothyroidism', 'organization': {'class': 'INDIV', 'fullName': 'Diekmann, Emanuel Amier'}, 'officialTitle': 'Osteopathy and Latent Hypothyroidism: Effectiveness of Osteopathic Treatment on TSH in Patients With Latent Hypothyroidism', 'orgStudyIdInfo': {'id': '17-5-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OMT-Group', 'description': 'The OMT-group will get an osteopathic treatment once a week for 1 hour for 5 weeks. The blood will be screened again after the treatment.', 'interventionNames': ['Other: OMT']}, {'type': 'NO_INTERVENTION', 'label': 'Controll Group', 'description': 'This group will receive no treatment. A blood screening is made again after 5 weeks.'}], 'interventions': [{'name': 'OMT', 'type': 'OTHER', 'description': 'Manuel osteopathic treatment of the spine', 'armGroupLabels': ['OMT-Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Emanuel Diekmann, DO', 'role': 'CONTACT', 'email': 'Emanuel.diekmann@gmx.de', 'phone': '0041788800341'}], 'overallOfficials': [{'name': 'Emanuel Diekmann, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Praxis fuer Osteopathy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emanuel Amier Diekmann', 'class': 'INDIV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'DO', 'investigatorFullName': 'Emanuel Amier Diekmann', 'investigatorAffiliation': 'Diekmann, Emanuel Amier'}}}}