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Osteopathy and Latent Hypothyroidism

Primary Purpose

Latent Hypothyroidism

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OMT
Sponsored by
Emanuel Amier Diekmann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Latent Hypothyroidism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • latent hypothyroidism

Exclusion Criteria:

  • Factors that Alter Thyroxine and Triiodothyronine Binding in Serum
  • Increased thyroxin-binding globulin
  • Decreased thyroxin-binding globulin
  • Binding inhibitors
  • Inherited Salicylates
  • Pregnancy
  • Androgens
  • Furosemide
  • Neonatal state
  • Anabolic steroids
  • Free fatty acids
  • Estrogens
  • Glucocorticoids
  • Phenytoin
  • Hepatitis
  • Severe illness
  • Carbamazepine
  • Porphyria
  • Hepatic failure
  • nonsteroidal antiinflammatory drug (variable, transient)
  • Heroin
  • Nephrosis
  • Heparin
  • Methadone
  • Nicotinic acid
  • Mitotane L-Asparaginase
  • 5-Fluorouracil
  • SERMS (e.g., tamoxifen, raloxifene)
  • Perphenazine
  • spinal pathologies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    OMT-Group

    Controll Group

    Arm 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.

    This group will receive no treatment. A blood screening is made again after 5 weeks.

    Outcomes

    Primary Outcome Measures

    Change in TSH Concentration

    Secondary Outcome Measures

    Full Information

    First Posted
    April 27, 2015
    Last Updated
    May 17, 2015
    Sponsor
    Emanuel Amier Diekmann
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02430857
    Brief Title
    Osteopathy and Latent Hypothyroidism
    Official Title
    Osteopathy and Latent Hypothyroidism: Effectiveness of Osteopathic Treatment on TSH in Patients With Latent Hypothyroidism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    October 2015 (Anticipated)
    Study Completion Date
    January 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Emanuel Amier Diekmann

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluates the effectiveness of stimulating the neurological segments c8-th5 in patients with latent hypothyroidism. One half of the participants will receive an osteopathic manuel treatment in order to stimulate the relevant segments, the other half will receive no treatment.
    Detailed Description
    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. A follow up blood screening (TSH, fT4) will be done. The results of both groups will be compared.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Latent Hypothyroidism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    OMT-Group
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Controll Group
    Arm Type
    No Intervention
    Arm Description
    This group will receive no treatment. A blood screening is made again after 5 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    OMT
    Intervention Description
    Manuel osteopathic treatment of the spine
    Primary Outcome Measure Information:
    Title
    Change in TSH Concentration
    Time Frame
    5 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: latent hypothyroidism Exclusion Criteria: Factors that Alter Thyroxine and Triiodothyronine Binding in Serum Increased thyroxin-binding globulin Decreased thyroxin-binding globulin Binding inhibitors Inherited Salicylates Pregnancy Androgens Furosemide Neonatal state Anabolic steroids Free fatty acids Estrogens Glucocorticoids Phenytoin Hepatitis Severe illness Carbamazepine Porphyria Hepatic failure nonsteroidal antiinflammatory drug (variable, transient) Heroin Nephrosis Heparin Methadone Nicotinic acid Mitotane L-Asparaginase 5-Fluorouracil SERMS (e.g., tamoxifen, raloxifene) Perphenazine spinal pathologies
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emanuel Diekmann, DO
    Phone
    0041788800341
    Email
    Emanuel.diekmann@gmx.de
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emanuel Diekmann, DO
    Organizational Affiliation
    Praxis fuer Osteopathy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Osteopathy and Latent Hypothyroidism

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