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CTRI Number  CTRI/2025/07/090054 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 28/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   How Gentle Electrical Therapies Like TENS and Microcurrent Can Help with Period Pain, Improve Daily Life, and Possibly Affect Stress Levels for period pain among young girls 
Scientific Title of Study   Effects of micro current therapy and transcutaneous electrical nerve stimulation on menstrual symptoms, quality of life and cortisol levels in primary dysmenorrhea 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suriya N 
Designation  Lecturer 
Affiliation  Saveetha Institute of Medical and Technical Sciences 
Address  Room 5A2, 5th floor health science block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai.

Kancheepuram
TAMIL NADU
602105
India 
Phone  9840267039  
Fax    
Email  suriya11nedunchezhiyan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kamalakannan M 
Designation  Professor 
Affiliation  Saveetha Institute of Medical and Technical Sciences 
Address  Room 5B2, 5th floor health science block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai.

Kancheepuram
TAMIL NADU
602105
India 
Phone  9600004487  
Fax    
Email  kamal1712@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kamalakannan M 
Designation  Professor 
Affiliation  Saveetha Institute of Medical and Technical Sciences 
Address  Room 5B2, 5th floor health science block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai.

Kancheepuram
TAMIL NADU
602105
India 
Phone  9600004487  
Fax    
Email  kamal1712@gmail.com  
 
Source of Monetary or Material Support  
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences 
 
Primary Sponsor  
Name  Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences 
Address  Room No E4, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai 602105 
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 
Suriya  Saveetha College of Physiotherapy  Room no 4E, 4th floor health science block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai.
Kancheepuram
TAMIL NADU 
09840267039

suriya11nedunchezhiyan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N944||Primary dysmenorrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Micro current therapy  30 mins per session, 3 menstrual days, 3 consecutive months 
Comparator Agent  Transcutaneus elecrtical nerve stimulation  30 mins per session, 3 menstrual days for 3 consecutive months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  Self- reported dysmenorrhea in the age group of 18-25 years
Had regular menstrual cycles (28-32 days)
Menstrual pain scoring at least 4 on NPRS for at least two consecutive months.
Both single and married women
Nullipara 
 
ExclusionCriteria 
Details  Women on oral contraceptives and hormonal therapy.
Continued pain medication (analgesics or NSAIDs) for pain
History of hospitalization due to any pelvic diseases or gynecological diseases
Female with history of any specific diseases and compulsory use of specific drugs
Contraindication to the use of Microcurrent and TENS
Recent abdominal or skin lesions 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Cortisol
Menstrual symptom questionnaire
36-item short-form quality of life 
Baseline and Post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="274"
Sample Size from India="274" 
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   Phase 1 
Date of First Enrollment (India)   21/07/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This randomized controlled trial aims to assess the effectiveness of Microcurrent Therapy and Transcutaneous Electrical Nerve Stimulation  in managing Primary Dysmenorrhea in young women. Primary dysmenorrhea refers to menstrual pain without underlying pelvic pathology and is a common gynecological complaint that impacts the quality of life, daily functioning, and psychological well-being.

Participants will be randomly allocated into two groups: Group A will receive Microcurrent therapy and group B will receive trancutaneuos electrical nerve stimulation therapy

Both interventions will be administered during the first three days of menstruation for three consecutive menstrual cycles. Each session will follow standardized parameters and treatment duration under the supervision of a trained physiotherapist. These therapies are safe, non-invasive, drug-free, and simple to administer, with minimal to no side effects, making them suitable for routine clinical use.

The study population will be recruited based on the selection criteria.
The following outcome measures will be assessed- cortisol, menstrual symptoms questionnaire, quality of life. Basic menstrual and Gynecological physiotherapy assessment will be carried out before intervention. Outcome assessments will be conducted at baseline and after completion of three treatment cycles to evaluate the treatment effects.

All participants will receive a participant information sheet that clearly outlines the study’s purpose, procedures, potential benefits, and risks. Written informed consent will be obtained prior to participation, ensuring full understanding, confidentiality and voluntary involvement. Participants may withdraw from the study at any point without penalty.

This trial aims to explore effective, non-pharmacological strategies for the management of primary dysmenorrhea and promote physiotherapy-based pain relief methods that can enhance the overall health and well-being of affected women.
 
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