| CTRI Number |
CTRI/2020/12/029910 [Registered on: 18/12/2020] Trial Registered Prospectively |
| Last Modified On: |
21/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of a simple, feasible and new TENS device for appetite reduction and weight loss in obesity |
|
Scientific Title of Study
|
Effect of transcutaneous electrical nerve stimulation of T6 dermatome by a portable, simple and cost-effective novel device on appetite reduction and weight loss in obese individuals |
| Trial Acronym |
|
|
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,
All India Institute of Medical Sciences
South
DELHI
110029
India |
| Phone |
8384065426 |
| Fax |
|
| Email |
pksahu9938@gmail.com |
|
Details of Contact Person
Public Query
|
| 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 |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
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
|
|
|
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, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Trancutaneous electrical nerve stimulation |
First T6 dermatome will be identified which is located at left upper quadrant of abdomen 2cm below the ribcage at left midclavicular line and will be marked. The T6 dermatome identification is already done in previous studies in similar fashion (Ruiz Tovar et al., 2014). Then, the left Thoracic 6 costovertebral junction will be marked and both these points will be used to stimulate. We will be using a wearable calibrated TENS machine (Avair Digital, AV-20). We will be using Gel-pad adhesive surface electrodes on the above mentioned sites to stimulate the T6 dermatome. The parameters of TENS selected to be applied are burst mode, frequency- 2.0 Hz, width- 300 microseconds. Participants will be treated before and after three meals of the day with T6 dermatomal electrical stimulation delivered by a Transcutaneous Electrical Nerve Stimulation (TENS) unit. Participants will receive 10-minute T6 dermatome cutaneous stimulation with TENS unit applied immediately before ingestion of the three main meals of the day (breakfast, lunch and dinner), and 10 minute stimulation applied immediately after ingestion of these meals. Participants will apply the stimulus six times daily for a treatment period of 1 month.Participants will keep a diary of weight once weekly and a weekly appetite sensation record. |
|
|
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 (VAS is found to be a reliable and valid tool to measure appetite level and the whole method is described in procedure section, Livingstone et al., 2000)
3. Dietary treatment failure
|
|
| ExclusionCriteria |
| Details |
1. Any known endocrine disease resulting in obesity
2. Evidence of metabolic, neurological, psychiatric, gynecological and cardiovascular disorder
3. Any evidence of infective 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 |
I. Appetite :
a.Desire to eat before and after meal (breakfast, lunch and dinner separately) from pre-post intervention and follow-up
b.Fullness before and after meal (breakfast, lunch and dinner separately) from pre-post intervention and follow-up
c.Hunger before and after meal (breakfast, lunch and dinner separately) from pre-post intervention and follow-up
II. Weight loss from pre-post intervention and follow-up
III. Body mass index in Kg/m2.
|
1. Before intervention
2. Each week during intervention and till after 4 weeks of completion of treatment
3. 4 weeks after completion of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Daily Caloric intake: Having patients their daily calories on ‘My fitness app’ on their smartphone. |
1. Everyday before starting intevention to 4 weeks after final intervention. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/12/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 single arm experimental trial aimed to find the effect of a portable, simple and cost-effective novel device on appetite reduction and weight loss in obese patients. Compared to other devices which is cumbersome and patients usually visit hospital for the interventions, we will be using a new device which is feasible to use at home and workplace after proper guidance from the investigators.The interventions will be carried out for 1 month and all subjects will be followed up 4 weeks after final intervention. |