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CTRI Number  CTRI/2019/08/020858 [Registered on: 23/08/2019] Trial Registered Prospectively
Last Modified On: 10/04/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   TENS in the management of obesity 
Scientific Title of Study   Effect of transcutaneous electrical nerve stimulation of T6 dermatome on appetite and weight reduction in obese individuals: a pilot study 
Trial Acronym  TENSOBESE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Agrawal 
Designation  Professor, Neurosurgery 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  7th floor, Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  9811282043  
Fax    
Email  drdeepak@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pradeep Kumar Sahu 
Designation  Physiotherapist 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no- 17, 6th floor, neurosciences centre, AIIMS

South
DELHI
110029
India 
Phone  8384065426  
Fax    
Email  pksahu9938@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pradeep Kumar Sahu 
Designation  Physiotherapist 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no- 17, 6th floor, neurosciences centre, AIIMS

South
DELHI
110029
India 
Phone  8384065426  
Fax    
Email  pksahu9938@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  Dr Deepak Agrawal 
Address  7th floor, Department of Neurosurgery, AIIMS, New Delhi, 110029 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Pradeep Kumar Sahu  Room no-17, 6th floor, Neurosciences Centre, AIIMS,New Delhi,110029 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Pradeep kumar sahu  All India Institute of Medical Sciences, New Delhi   Room no-23, Physiotherapy room, Neurosciences centre, AIIMS, New Delhi
South
DELHI 		 8384065426

pksahu9938@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E660||Obesity due to excess calories,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Transcutaneous electrical nerve stimulation (TENS) of T6 dermatome will be done.   A caliberated TENS equipment will be used to stimulate the T6 dermatome. The parameters of TENS selected to be applied are burst mode, frequency- 2.0 Hz, width- 300 microsec, Duration- 30 mins, once a day, once in a week and for 12 weeks.Intensity will be gradually increased from 0mA till the subject will feel a comfortable tingling sensation beneath and surrounding to the electrode and 20mA is considered as the maximum intensity. If subjects unable to feel any sensation with more than 20mA intensity they will be excluded from the study. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. BMI > 30 kg/m2
2. Appetite level on VAS ≥ 3
3. Dietary treatment failure
 
 
ExclusionCriteria 
Details  1. Any known endocrine disease resulting in obesity
2. Evidence of metabolic, neurological, psychiatric, gynecological and cardiovascular disorders
3. Any evidence of infection or malignant conditions
4. Previous abdominal surgeries
5. Withdrawal of consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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.   1. Baseline
2. on each intervention session
3. 8 weeks after the final intervetion 
 
Secondary Outcome  
Outcome  TimePoints 
1. Weight will be measured by caliberated standardized weigh machine.
2. BMI: After weight and height measurement by measuring tools,BMI will be calculated. 		 1. Baseline
2. on each intervention session
3. 8 weeks after the final intervetion 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/08/2019 
Date of Study Completion (India) 17/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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