Osteopathy and Latent Hypothyroidism
Primary Purpose
Latent Hypothyroidism
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OMT
Sponsored by
About this trial
This is an interventional treatment trial for Latent Hypothyroidism
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
OMT-Group
Controll Group
Arm Description
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.
This group will receive no treatment. A blood screening is made again after 5 weeks.
Outcomes
Primary Outcome Measures
Change in TSH Concentration
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02430857
Brief Title
Osteopathy and Latent Hypothyroidism
Official Title
Osteopathy and Latent Hypothyroidism: Effectiveness of Osteopathic Treatment on TSH in Patients With Latent Hypothyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emanuel Amier Diekmann
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Hypothyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OMT-Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Controll Group
Arm Type
No Intervention
Arm Description
This group will receive no treatment. A blood screening is made again after 5 weeks.
Intervention Type
Other
Intervention Name(s)
OMT
Intervention Description
Manuel osteopathic treatment of the spine
Primary Outcome Measure Information:
Title
Change in TSH Concentration
Time Frame
5 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emanuel Diekmann, DO
Phone
0041788800341
Email
Emanuel.diekmann@gmx.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emanuel Diekmann, DO
Organizational Affiliation
Praxis fuer Osteopathy
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Osteopathy and Latent Hypothyroidism
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