Osteopathy and Latent Hypothyroidism

Latent Hypothyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02430857
• Other study ID #: 17-5-2015
• Status: Not yet recruiting
• Phase: N/A
• First received: April 27, 2015
• Last updated: May 17, 2015
• Start date: October 2015
• Est. completion date: January 2016

Study information

• Verified date: May 2015
• Source: Diekmann, Emanuel Amier
• Contact: Emanuel Diekmann, DO
• Phone: 0041788800341
• Email: Emanuel.diekmann[@]gmx.de
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothyroidism
• Latent Hypothyroidism

Intervention

Other:
• OMT
Manuel osteopathic treatment of the spine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Emanuel Amier Diekmann

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in TSH Concentration		5 weeks	No