| 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
|
|
|
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
|
|
|
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. |