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CTRI Number  CTRI/2021/09/036366 [Registered on: 09/09/2021] Trial Registered Prospectively
Last Modified On: 02/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A comparative study on the effect of high and low frequency nerve stimulation on pain, physical activity and quality of life in caesarean section patients.    
Scientific Title of Study   A comparative study on the effect of conventional TENS and acupuncture TENS on pain, physical activity and quality of life post lower segment caesarean section (LSCS).    
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kajal Rajendra Vyas 
Designation  Post Graduate Student-Masters in Community Physiotherapy 
Affiliation  Sancheti Institute College of Physiotherapy. 
Address  Sancheti Institute College of Physiotherapy, Thube Park, Shivajinagar, Pune.

Pune
MAHARASHTRA
411005
India 
Phone  8793148068  
Fax    
Email  kajal.vyas01@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suroshree Mitra 
Designation  Associate Professor, Department of Community Physiotherapy 
Affiliation  Sancheti Institute College of Physiotherapy. 
Address  Sancheti Institute College of Physiotherapy, Thube Park, Shivajinagar, Pune.

Pune
MAHARASHTRA
411005
India 
Phone  8087715596  
Fax    
Email  drsurmitra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suroshree Mitra 
Designation  Associate Professor, Department of Community Physiotherapy 
Affiliation  Sancheti Institute College of Physiotherapy. 
Address  Sancheti Institute College of Physiotherapy, Thube Park, Shivajinagar, Pune.

Pune
MAHARASHTRA
411005
India 
Phone  8087715596  
Fax    
Email  drsurmitra@gmail.com  
 
Source of Monetary or Material Support  
Sancheti Institute College of Physiotherapy 
 
Primary Sponsor  
Name  Sancheti Institute College of Physiotherapy 
Address  Sancheti Institue College of Physiotherapy, Thube Park, Shivajinagar, Pune. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kajal Rajendra Vyas  Kamala Nehru Hospital  Ward number 10 and 11, Division: Post Natal Care (PNC), Department: Obstetrics and Gynecology, Mangalwar Peth Rd, near Kasba Post Office, Gandhinagar, Mangalwar Peth, Kasba Peth.
Pune
MAHARASHTRA 		 8793148068

kajal.vyas01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sancheti Institute for Orthopaedics and Rehabilitation Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Acupuncture TENS  Low TENS of 4hz frequency applied for 20 mins for 3 days. 
Intervention  Conventional TENS  High TENS of 100hz frequency applied for 20 mins for 3 days.  
Comparator Agent  Placebo TENS  Placebo TENS with no electrical stimulation will be applied for 20 mins for 3 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1)Women undergone LSCS (Day 1-3)
2)Pain on VAS (having pain intensity more than 4mm)
3)Age group: 18-35
4)Subject who is conscious and oriented for device installation after anesthetic effect.
5)Subject who gives consent and is willing to participate in the clinical study.



 
 
ExclusionCriteria 
Details  1)Subjects diagnosed with other diseases such as preoperative presence of maternal mental or neurological diseases affecting evaluation of pain.
2)Subjects diagnosed with psychiatric conditions.
3)Having metallic implants.
4)Altered sensations.
5)Any open wound or infection surrounding the incision site.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Scale  Pre and Post application of TENS 
 
Secondary Outcome  
Outcome  TimePoints 
Kartz Index  On 1st and 3rd postoperative day, Pre and Post application of TENS 
Brief Pain Inventory questionnaire  On 1st and 3rd postoperative day, Pre and Post application of TENS 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/09/2021 
Date of Study Completion (India) 01/04/2022 
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
Modification(s)  		 Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 This is a randomized, parallel group, active control trial. It is a single blinded study that studies the effect of conventional and acupuncture TENS on pain, physical activity and quality of life post LSCS. The intervention group will receive conventional TENS, acupuncture TENS and placebo TENS in 3 groups along with conventional physiotherapy treatment. The duration of TENS application will be 20 minutes for 3 days. 
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