Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000040460
Ethics application status
Approved
Date submitted
16/08/2006
Date registered
12/01/2007
Date last updated
14/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised clinical trial (RCT) of the effect of Neuro-Emotional Technique (NET) on the clinical manifestations of primary overt hypothyroidism
Scientific title
A randomised clinical trial (RCT) of the effect of Neuro-Emotional Technique (NET) on the clinical manifestations of primary overt hypothyroidism
Secondary ID [1] 252148 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypothyroidism 1534 0
Condition category
Condition code
Metabolic and Endocrine 1631 1631 0 0
Other metabolic and endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neuro-Emotional Technique (NET) Neuro-Emotional Technique is a technique used by chiropractors which is similar to Cognitive behavioural therapy (CBT). Participants in the treatment group will receive 10 NET treatments over a period of 6 weeks. The treatments will last for approximately 5-20 mins in duration.
Intervention code [1] 1315 0
Treatment: Other
Comparator / control treatment
Participants in the placebo (sham) intervention group will receive a non-therapeutic sham intervention. This placebo intervention mimics the NET protocol with the purported therapeutic components removed and replaced with innocous steps. The placebo intervention will be administered at the same frequency as the treatment group.
Control group
Placebo

Outcomes
Primary outcome [1] 258734 0
To evaluate the influence of Neuro-Emotional Technique (NET) on the clinical manifestations of individuals with primary overt hypothyroidism. Outcome measures include: Depression scores as measured by the Depression, Anxiety, Stress (DASS) questionnaire.
Timepoint [1] 258734 0
Administered at the beginning of the trial, and at 6 weeks and 6 months.
Secondary outcome [1] 3927 0
Basal Temperature (BT) measurement
Timepoint [1] 3927 0
Measures will be performed every day for the duration of the trial (6 months).
Secondary outcome [2] 3928 0
Basal Heart Rate (BHR) measurement
Timepoint [2] 3928 0
Measures will be performed every day for the duration of the trial (6 months).
Secondary outcome [3] 263471 0
Self report daily health and well being questionniare.
Timepoint [3] 263471 0
Measures will be performed every day for the duration of the trial (6 months).
Secondary outcome [4] 264780 0
To evaluate the influence of Neuro-Emotional Technique (NET) on the clinical manifestations of individuals with primary overt hypothyroidism. Outcome measures include measurement of Anxiety and Stress using the DASS questionnaire.
Timepoint [4] 264780 0
Administered at the beginning of the trial, and at 6 weeks and 6 months.
Secondary outcome [5] 264781 0
To evaluate the influence of Neuro-Emotional Technique (NET) on the clinical manifestations of individuals with primary overt hypothyroidism. Outcome measures include: Serum thyroid stimulating hormone (TSH)
Timepoint [5] 264781 0
Administered at the beginning of the trial, and at 6 weeks and 6 months.
Secondary outcome [6] 264782 0
To evaluate the influence of Neuro-Emotional Technique (NET) on the clinical manifestations of individuals with primary overt hypothyroidism. Outcome measures include: Serum thyroxine (T4)
Timepoint [6] 264782 0
Administered at the beginning of the trial, and at 6 weeks and 6 months.
Secondary outcome [7] 264783 0
To evaluate the influence of Neuro-Emotional Technique (NET) on the clinical manifestations of individuals with primary overt hypothyroidism. Outcome measures include: Serum Triiodothyronine (T3)
Timepoint [7] 264783 0
Administered at the beginning of the trial, and at 6 weeks and 6 months.
Secondary outcome [8] 264784 0
To evaluate the influence of Neuro-Emotional Technique (NET) on the clinical manifestations of individuals with primary overt hypothyroidism. Outcome measures include: Serum Thyroid peroxidase antibodies (anti-TPO)
Timepoint [8] 264784 0
Administered at the beginning of the trial, and at 6 weeks and 6 months.
Secondary outcome [9] 264785 0
To evaluate the influence of Neuro-Emotional Technique (NET) on the clinical manifestations of individuals with primary overt hypothyroidism. Outcome measures include: Serum Thyroglobulin antibodies (anti-TG)
Timepoint [9] 264785 0
Administered at the beginning of the trial, and at 6 weeks and 6 months.
Secondary outcome [10] 264786 0
To evaluate the influence of Neuro-Emotional Technique (NET) on the clinical manifestations of individuals with primary overt hypothyroidism. Outcome measures include: Short Form -36 (SF-36) questionnaire
Timepoint [10] 264786 0
Administered at the beginning of the trial, and at 6 weeks and 6 months.

Eligibility
Key inclusion criteria
Hypothyroid sufferers.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Iatrogenic hypothyroidism, < 18 years, significant co-morbidities, Deaf/mute, Non-English speaking, Serious illness/mental illness, Pregnant, Individuals recently diagnosed (within the last 6 months) with hypothyroidism, medications that are known to influence thyroid function other than standard meds for hypothyroidism.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Person responsible for applying inclusion/exclusion criteria was not aware of the group to which the participant would be allocated. Participants are not advised which group they have been allocated. Central randomisation performed by phone /computer well after participants have been accepted into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using random.org This is a web site which assists the randomisation of participants by providing a true random sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Doube blind. Participants are blind as to the group they have been allocated (treatment or sham). In addition, the assessors (pathologists) are blind to the allocation. The data analyst is also blinded to the status of the participants.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1777 0
Charities/Societies/Foundations
Name [1] 1777 0
Australian Spinal Research Foundation
Country [1] 1777 0
Australia
Primary sponsor type
Individual
Name
A/Prof Rod Bonello
Address
Department of Chiropractic, Macquarie University, NSW 2109
Country
Australia
Secondary sponsor category [1] 1582 0
None
Name [1] 1582 0
None
Address [1] 1582 0
Country [1] 1582 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3333 0
Macquarie University Human Ethics Committee-Macquarie University Sydney
Ethics committee address [1] 3333 0
Ethics committee country [1] 3333 0
Australia
Date submitted for ethics approval [1] 3333 0
Approval date [1] 3333 0
Ethics approval number [1] 3333 0

Summary
Brief summary
This project is a comparative study investigating the effects of Neuro-Emotional Technique (NET) treatment on Hypothyroidism. Hypothyroidism is defined as any condition that results in a decrease in the amount of circulating thyroid hormones in the body. NET is a therapeutic procedure developed by Chiropractors as an adjunct to standard Chiropractic techniques. The development and structure of this technique ties in with the biopsychosocial model of health care, which represents a holistic approach to patient management. General aims: -To determine the effect of Neuro-Emotional Technique (NET) in the treatment and management of primary hypothyroidism. Specific Aims: - To determine the emotional/ psychological/ social/ hormonal profile of a group of primary overt hypothyroid participants. - To determine if the emotional/psychological/ social/hormonal profile of a group of primary overt hypothyroid participants changes with NET treatment. - To determine if primary overt hypothyroidism can be affected by NET treatment in the short term (2 months) and the medium term (6 months) Interpretation of Results and Discussion Accumulated data will be statistically analysed using T-tests, longitudinal analysis with an alpha value of 0.05
Trial website
Trial related presentations / publications
1) Brown BT, Bonello R, Pollard H. The biopsychosocial model and hypothyroidism Chiropractic & Osteopathy 2005, 13:5

2) Brown BT, Bonello R, Pollard H. The use of Traditional Chinese Medical Principles in Chiropractic Technique Chiropr J Aust 2008, 38: 18-26

3) Brown, BT, Bonello R, Pollard H. Response to a letter to the editor Re:”The use of Traditional Chinese Medical Principles in Chiropractic Technique” Chiropr J Aust 2008, 38: 18-26. in Chiropr J Aust 2008, 39:122

4) Brown BT, Bonello R, Pollard H, Graham, P. The influence of a biopsychosocial-based treatment approach on the clinical manifestations of primary overt hypothyroidism: a protocol for a pilot study Trials 2010, 11:106

Conference Proceedings
1) Brown BT. “A Biopsychosocial Approach to Hypothyroidism” Third International Congress of Complementary Medicine Research 29-31 March 2008, Sydney Australia
Public notes

Contacts
Principal investigator
Name 27922 0
Address 27922 0
Country 27922 0
Phone 27922 0
Fax 27922 0
Email 27922 0
Contact person for public queries
Name 10504 0
Benjamin Brown
Address 10504 0
Department of Chiropractic, Macquarie University, 2109
Country 10504 0
Australia
Phone 10504 0
+61 02 9850 7694
Fax 10504 0
+61 02 9850 6565
Email 10504 0
benjamin.brown@students.mq.edu.au
Contact person for scientific queries
Name 1432 0
Benjamin Brown
Address 1432 0
Department of Chiropractic, Macquarie University, 2109
Country 1432 0
Australia
Phone 1432 0
+61 02 9850 7694
Fax 1432 0
+61 02 9850 6565
Email 1432 0
benjamin.brown@students.mq.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe influence of a biopsychosocial-based treatment approach to primary overt hypothyroidism: A protocol for a pilot study.2010https://dx.doi.org/10.1186/1745-6215-11-106
N.B. These documents automatically identified may not have been verified by the study sponsor.