| CTRI Number |
CTRI/2023/11/060030 [Registered on: 20/11/2023] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing TENS and core exercises to relieve pain during menstruation |
|
Scientific Title of Study
|
Comparative study of Transcutaneous electrical nerve stimulation versus Core Stabilization exercises on pain in primary dysmenorrehea |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya jain |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy Sumandeep Vidyapeth Deemed to be Unviersity |
| Address |
College of Physiotherapy Sumandeep Vidyapeth Deemed to be Unviersity
Piparia,Waghodia,Vadodara-391760
Vadodara
GUJARAT
391760
India |
| Phone |
8999295011 |
| Fax |
|
| Email |
jainaish2303@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNeha Mukkamala |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy Sumandeep Vidyapeth Deemed to be Unviersity |
| Address |
College of Physiotherapy Sumandeep Vidyapeth Deemed to be Unviersity
Piparia,Waghodia,Vadodara-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9898216184 |
| Fax |
|
| Email |
neha.cop@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrNeha Mukkamala |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy Sumandeep Vidyapeth Deemed to be Unviersity |
| Address |
College of Physiotherapy Sumandeep Vidyapeth Deemed to be Unviersity
Piparia,Waghodia,Vadodara-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9898216184 |
| Fax |
|
| Email |
neha.cop@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Electrotherapy lab of College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University |
|
|
Primary Sponsor
|
| Name |
Aishwarya Jain |
| Address |
College of Physiotherapy, Sumandeep VIdyapeeth Deemed to be Unviersity Piparia ,Wagaghodia,vadodara 391760 |
| Type of Sponsor |
Other [Self Funded ] |
|
|
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 |
| Aishwarya Jain |
Constituent Institutes of Sumandeep Vidyapeeth |
College of Physiotherapy, Sumandeep Vidyapeeth PIparia,Waghodia,Vadodara 391760
Vadodara
GUJARAT
Vadodara
GUJARAT |
8999295011
jainaish2303@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary Dysmenorrehea |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Core Stabilization Exercises |
5 core stabilization exercises will be given to the females with dysmenorrhea.Duration of intervention is 2 months. |
| Intervention |
Transcutaneous Electrical Nerve Stimulation |
High TENS will be given At the lumbar region and suprapubic region to females with dysmenorrhea.Duration of intervention is 2 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1] Females diagnosed with primary dysmenorrhea. Females Age of group 18-25 years and with a regular menstrual cycle
|
|
| ExclusionCriteria |
| Details |
1] Females with any other gynecological condition Such as Polycystic ovary disease or polycystic ovarian disease
2] Females attending regular exercise 3 days per week
3] Females who are having chronic low back pain
4] Females taking regular medication during menstruation
5] Females who have undergone any surgery in lower back region / gynecological surgery
6] Females having open wounds, scar or skin infection
7] Females having any neurological condition such as epilepsy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| visual analog Scale |
In the TENS group outcome measures will be taken in all three menstrual cycles
the pre-treatment outcome measure will be taken on 1st day and the post-treatment outcome measure will be taken on 3rd day of each menstrual cycle
In the Core stabilization group, pre-treatment outcome measures will be taken on 1st day of 1st menstrual cycle and
post-treatment outcome measures will be taken on 1st day of 2nd menstrual cycle and 1st day of 3rd menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Menstrual Distress Questionnaire |
In the TENS group outcome measures will be taken in all three menstrual cycles
the pre-treatment outcome measure will be taken on 1st day & the post-treatment outcome measure will be taken on 3rd day of each menstrual cycle
In the Core stabilization group, pre-treatment outcome measures will be taken on 1st day of 1st menstrual cycle &
post-treatment outcome measures will be taken on 1st day of 2nd menstrual cycle & 1st day of 3rd menstrual cycle |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/11/2023 |
| Date of Study Completion (India) |
25/03/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, Females will allocated into 2 random groups. 1 Group will receive Transcutaneous electrical nerve stimulation during the menses for 1st 3 days with frequency of 50-120 Hz, pulse width of 100ms, and intensity as tolerated. On the 1st day of 1st menstrual cycle outcome measures (visual analog scale and menstrual distress questionnaire) will be taken pretreatment and immediately post-treatment. The participants will be treated for 3 days with TENS and at the end of the 3rd day, outcome measures (visual analog scale and menstrual distress questionnaire) will be taken.2nd group will receive core stabilization exercises will commence from the 6th day of the menstrual cycle and continued till the next menstrual cycle. The whole program will last for 45 minutes with 10 minutes of warm-up, 10 minutes of cool down, and 20-25 minutes of the main program, 5 core stabilization exercises including exercises and 5 repetitions will be given. 1 session per day will be given for 3 days per week and continued for 3 menstrual cycles. On the first day of 1st menstrual cycle outcome measures (visual analog scale and menstrual distress questionnaire) will be taken and post-treatment outcome measures (visual analog scale and menstrual distress questionnaire) will be taken on 1st day of 2nd menstrual cycle and 1st of last menstrual cycle and data will be statistically analyzed
|