Latent HypothyroidismNCT02430857
Osteopathy and Latent Hypothyroidism
A study testing OMT in people with Latent Hypothyroidism, run by Emanuel Amier Diekmann.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Latent Hypothyroidism
- What is being tested?
- OMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- latent hypothyroidism
Who cannot join
- Factors that Alter Thyroxine and Triiodothyronine Binding in Serum
- Increased thyroxin-binding globulin
- Decreased thyroxin-binding globulin
- Binding inhibitors
- Inherited Salicylates
- Pregnancy
Show all 30Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Latent Hypothyroidism
- Being tested
- OMT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMTOther
Manuel osteopathic treatment of the spine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: OMT |
| Controll Group | No intervention | This group will receive no treatment. A blood screening is made again after 5 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TSH Concentration
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emanuel Amier Diekmann
- Responsible party
- Sponsor-investigator, Emanuel Amier Diekmann, Diekmann, Emanuel Amier
- Investigators
- Emanuel Diekmann, DO, Principal investigator, Praxis fuer Osteopathy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430857
- Sponsor's protocol ID
- 17-5-2015
- Status last verified
- May 2015
- First submitted
- 27 Apr 2015
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathy and Latent Hypothyroidism: Effectiveness of Osteopathic Treatment on TSH in Patients With Latent Hypothyroidism
- ClinicalTrials.gov ID
- NCT02430857
- Acronym / sponsor ID
- 17-5-2015
- Conditions
- Latent Hypothyroidism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Emanuel Amier Diekmann
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMT-Group | Experimental | Other: OMTThe 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. |
| Controll Group | No intervention | –This group will receive no treatment. A blood screening is made again after 5 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- latent hypothyroidism
Key exclusion criteria (30 listed)
- Factors that Alter Thyroxine and Triiodothyronine Binding in Serum
- Increased thyroxin-binding globulin
- Decreased thyroxin-binding globulin
- Binding inhibitors
- Inherited Salicylates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMTManuel osteopathic treatment of the spine | Other | OMT-Group |
Primary outcome
Change in TSH Concentration
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuel Diekmann, DO principal investigator
Praxis fuer Osteopathy
Questions about this trial
What is this clinical trial studying?
A study testing OMT in people with Latent Hypothyroidism, run by Emanuel Amier Diekmann.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emanuel Diekmann, DO (0041788800341, Emanuel.diekmann@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TSH Concentration (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015; AzTrials last refreshed its copy on 31 Oct 2026.