NCT02430857

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

Same day

First QC Date

April 27, 2015

Last Update Submit

May 17, 2015

Conditions

Latent Hypothyroidism

Outcome Measures

Primary Outcomes (1)

  • Change in TSH Concentration

    5 weeks

Study Arms (2)

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

OMTOTHER

Manuel osteopathic treatment of the spine

OMT-Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • latent hypothyroidism

You may not qualify if:

  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Emanuel Diekmann, DO

    Praxis fuer Osteopathy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanuel Diekmann, DO

CONTACT

0041788800341Emanuel.diekmann@gmx.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DO

Study Record Dates

First Submitted

April 27, 2015

First Posted

April 30, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

May 19, 2015

Record last verified: 2015-05