Osteopathy and Latent Hypothyroidism

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: Latent Hypothyroidism
• Intervention / Treatment: Other: OMT

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

• Study Contact: Name: Emanuel Diekmann, DO; Phone Number: 0041788800341; Email: Emanuel.diekmann@gmx.de

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	5 weeks

Collaborators and Investigators

• Sponsor: Emanuel Amier Diekmann
• Investigators: Principal Investigator: Emanuel Diekmann, DO, Praxis fuer Osteopathy

Study record dates

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: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: 17-5-2015