Effect of transcutaneous electrical nerve stimulation of T6 dermatome on appetite and weight reduction in obese individuals: a pilot study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 1. Appetite level: A visual analogue scale (VAS) will be used to measure the appetite level. The scale is caliberated from 0 to 100 with mm interval. VAS (0mm) is considered as "not at all hungry and (100 mm) is "as hungry as I have ever felt". The other side of the scale with marking only 0 and 100 will be shown to subjects and they will mark their current appetite level.
Study Overview
Brief Summary
This will be a open label pilot study aimed to find the effect of transcutaneous electrical nerve stimulation of T6 dermatome on appetite and weight loss in obese individuals. Interventions will be carried out once a week and for 12 weeks. The outcome measures will be level of appetite on visual analogue scale, weight and BMI evaluated before intervention, on each intervention day and 8 weeks after final treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •BMI > 30 kg/m2
- •Appetite level on VAS ≥ 3
- •Dietary treatment failure.
Exclusion Criteria
- •Any known endocrine disease resulting in obesity
- •Evidence of metabolic, neurological, psychiatric, gynecological and cardiovascular disorders
- •Any evidence of infection or malignant conditions
- •Previous abdominal surgeries
- •Withdrawal of consent.
Outcomes
Primary Outcomes
1. Appetite level: A visual analogue scale (VAS) will be used to measure the appetite level. The scale is caliberated from 0 to 100 with mm interval. VAS (0mm) is considered as "not at all hungry and (100 mm) is "as hungry as I have ever felt". The other side of the scale with marking only 0 and 100 will be shown to subjects and they will mark their current appetite level.
Time Frame: 1. Baseline | 2. on each intervention session | 3. 8 weeks after the final intervetion
Secondary Outcomes
- 1. Weight will be measured by caliberated standardized weigh machine.(2. BMI: After weight and height measurement by measuring tools,BMI will be calculated.)