Osteopathy and Latent Hypothyroidism | NCT02430857

Studies
Osteopathy and Latent Hypothyroidism

NCT02430857

Sponsor

Emanuel Amier Diekmann

Status

Unknown status

Last Update Posted

May 19, 2015Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Latent Hypothyroidism

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2015Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Apr 27, 2015

First Submission Date that Met QC Criteria

Apr 27, 2015

First Posted Date

Apr 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2015

Last Update Posted Date

May 19, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OMT-Group	Experimental	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
Controll Group	No Intervention	This group will receive no treatment. A blood screening is made again after 5 weeks.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OMT	Other	Manuel osteopathic treatment of the spine	OMT-Group

Measure	Description	Time Frame
Change in TSH Concentration		5 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emanuel Diekmann, DO	Contact	0041788800341		Emanuel.diekmann@gmx.de

Overall Officials

Name	Affiliation	Role
Emanuel Diekmann, DO	Praxis fuer Osteopathy	Principal Investigator

Locations

Not provided