Osteopathy and Latent Hypothyroidism

May 17, 2015 updated by: Emanuel Amier Diekmann

Osteopathy and Latent Hypothyroidism: Effectiveness of Osteopathic Treatment on TSH in Patients With Latent Hypothyroidism

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OMT-Group
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.
Other: OMT
Manuel osteopathic treatment of the spine
No Intervention: Controll Group
This group will receive no treatment. A blood screening is made again after 5 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in TSH Concentration
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emanuel Amier Diekmann

Investigators

  • Principal Investigator: Emanuel Diekmann, DO, Praxis fuer Osteopathy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

April 27, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimate)

April 30, 2015

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 17, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-5-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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