Abstract
BackgroundHypothyroidism is a prevalent endocrine condition. Individuals with this disease are commonly managed through supplementation with synthetic thyroid hormone, with the aim of alleviating symptoms and restoring normal thyroid stimulating hormone levels. Generally this management strategy is effective and well tolerated. However, there is research to suggest that a significant proportion of hypothyroid sufferers are being inadequately managed. Furthermore, hypothyroid patients are more likely to have a decreased sense of well-being and more commonly experience constitutional and neuropsychiatric complaints, even with pharmacological intervention.The current management of hypothyroidism follows a biomedical model. Little consideration has been given to a biopsychosocial approach to this condition. Within the chiropractic profession there is growing support for the use of a biopsychosocial-based intervention called Neuro-Emotional Technique (NET) for this population.Methods/DesignA placebo-controlled, single-blinded, randomised clinical pilot-trial has been designed to assess the influence of Neuro-Emotional Technique on a population with primary overt hypothyroidism. A sample of 102 adults (≥18 years) who meet the inclusion criteria will be randomised to either a treatment group or a placebo group. Each group will receive ten treatments (NET or placebo) over a six week period, and will be monitored for six months. The primary outcome will involve the measurement of depression using the Depression, Anxiety and Stress Scale (DASS). The secondary outcome measures to be used are; serum thyroid stimulating hormone, serum free-thyroxine, serum free-triiodothyronine, serum thyroid peroxidase auto-antibodies, serum thyroglobulin auto-antibodies as well as the measurement of functional health and well-being using the Short-Form-36 Version 2. The emotional states of anxiety and stress will be measured using the DASS. Self-measurement of basal heart rate and basal temperature will also be included among the secondary outcome measures. The primary and secondary measures will be obtained at commencement, six weeks and six months. Measures of basal heart rate and basal temperature will be obtained daily for the six month trial period, with recording to commence one week prior to the intervention.DiscussionThe study will provide information on the influence of NET when added to existing management regimens in individuals with primary overt hypothyroidism.Trial RegistrationANZCTR Number: 12607000040460
Highlights
The study will provide information on the influence of Neuro-Emotional Technique (NET) when added to existing management regimens in individuals with primary overt hypothyroidism
This manuscript has been compiled to outline the methodology for a randomised-controlled clinical study investigating a biopsychosocial approach to primary overt hypothyroidism that adheres to the Consolidated Standard of Reporting Trials (CONSORT) [14] checklist in its design
We have presented the design and protocol for a placebo-controlled, single-blinded RCT that will investigate the influence of a biopsychosocial-based treatment approach for primary overt hypothyroidism
Summary
Hypothyroidism is a frequently encountered clinical condition and is the most common cause of pathological hormone deficiency. Laboratory testing in individuals with primary overt hypothyroidism typically depicts an elevated serum thyroid stimulating hormone (TSH) level, and a decrease in serum free-thyroxine (FT4) levels [3]. The gold standard treatment for individuals with hypothyroidism is supplementation using a synthetic version (Levothyroxine Sodium) of the thyroid hormone thyroxine [1]. Within the chiropractic profession there are anecdotal reports and case studies [13] to suggest that a biopsychosocial-based treatment approach may be applicable to hypothyroidism. This manuscript has been compiled to outline the methodology for a randomised-controlled clinical study investigating a biopsychosocial approach to primary overt hypothyroidism that adheres to the CONSORT [14] checklist in its design
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