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CTRI Number  CTRI/2024/07/070671 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 14/07/2024
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   Effect of kinesiotaping with TENS on menstrual pain in college going female students 
Scientific Title of Study   Effect of kinesiotaping with TENS on Dysmenorrhea in college going female students:An Experimental Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Megha Bhagatram Kukreja 
Designation  Intern 
Affiliation  Dr. Ulhas Patil College of Physiotherapy 
Address  NH 06 Gat No 57 1 Khirdi Shivar Tal And Dist Jalgaon Jalgaon MAHARASHTRA 42530 INDIA

Jalgaon
MAHARASHTRA
42530
India 
Phone  7020788856  
Fax    
Email  meghakukreja42@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chaitali Neve 
Designation  Assistant professor 
Affiliation  Dr. Ulhas Patil College of Physiotherapy 
Address  NH 06 Gat No 57 1 Khirdi Shivar Tal And Dist Jalgaon Jalgaon MAHARASHTRA 42530 INDIA

Jalgaon
MAHARASHTRA
42530
India 
Phone  9518719182  
Fax    
Email  chaitalisneve123@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chaitali Neve 
Designation  Assistant professor 
Affiliation  Dr. Ulhas Patil College of Physiotherapy 
Address  NH 06 Gat No 57 1 Khirdi Shivar Tal And Dist Jalgaon Jalgaon MAHARASHTRA 42530 INDIA

Jalgaon
MAHARASHTRA
42530
India 
Phone  9518719182  
Fax    
Email  chaitalisneve123@gmail.com  
 
Source of Monetary or Material Support  
Dr. Ulhas Patil College of Physiotherapy 
 
Primary Sponsor  
Name  Megha Kukreja 
Address  NH 06 Gat No 57 1 Khirdi Shivar Tal And Dist Jalgaon Jalgaon Maharashtra 42530 India 
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 Chaitali Neve  Dr.Ulhas Patil College of Physiotherapy  NH 06 Gat No 57 1 Khirdi Shivar Tal And Dist Jalgaon Jalgaon MAHARASHTRA 42530 India
Jalgaon
MAHARASHTRA 		 9518719182

chaitalisneve123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Of Dr.Ulhas Patil College Of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N719||Inflammatory disease of uterus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Kinesiotaping with TENS  A piece of tape 5cm in width and 7-8 cm in length will be applied right from navel or in suprapubic region and other piece of tape 10cm in length will be applied to make cross shape with first piece. Rub the tape for adhesiveness. Along with tape TENS was given.  
Intervention  Transcutaneous Electrical Nerve Stimulator(TENS)   Electrodes will be placed over more painful area. Depending upon area 2 or 4 electrodes will be used. High frequency TENS is used for 10 to 15 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  26.00 Year(s)
Gender  Female 
Details  1.Unmarried and Nullliparous Females.
2.Age between 18-26 years
3.Pain on VAS (moderate to severe)
4.Regular Menstruation Cycle (28±7) Females who had Menstrual cramps for more than 3 months.

 
 
ExclusionCriteria 
Details  1.Females with other MSK and Neuromuscular pathological findings.
2.Females who uses other form of non- pharmacological method or pain medications.
3.Females who complaining about LBP and Lower abdomen pain in between their cycles.
4.Mental health problems
5.Any spinal conditions
6.Surgeries 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Visual Analogue Scale(VAS)
2.Menstrual Symptom Questionnaire(MSQ) 		 Pre and Post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   25/07/2024 
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="0"
Months="6"
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  

AIM: The aim of the study is to see the effect of  kinesiotaping with TENS on dysmenorrhea in college going female students.

  OBJECTIVE:     To determine the effect of kinesiotaping with TENS on dysmenorrhea in college going female students.       

To determine the effect of TENS on dysmenorrhea in college going female students.  

  To compare the effect of kinesiotaping with TENS and TENS on dysmenorrhea  in college going female students.


HYPOTHESIS

   Null Hypothesis[HO]: There will be no significant effect of kinesiotaping with TENS on dysmenorrhea in college going females students.

 There will be no significant effect of TENS on dysmenorrhea in college going females students     

  Alternate Hypothesis[HA]:There will be significant effect of kinesiotaping with TENS on dysmenorrhea in college going females students.

       There will be significant effect of TENS on dysmenorrhea in college going female          students.


    PROCEDURE:

An intervention study among the age group 18-26 years. To conduct the following study approval from the ethical committee from Dr. Ulhas Patil College of Physiotherapy was taken.

Total 32 females were selected according to inclusion criteria and exclusion criteria.

The female will be allotted randomly in 2 groups,(Group A=16,Group B=16). The procedure will be explained and written consent will be obtained from the individuals.

Treatment will be given on first or second day of menses, depending upon the day of severe pain experienced by females.

 

Pain will be measured using VAS and other dysmenorrheal symptoms will be measured using menstrual symptom questionnaire before the treatment.

Post treatment evaluation will be done after 24hr of treatment.

Females will be evaluated according to the format.

All the harms will be explained to the participants before the treatments.

 

GROUP A:

TENS will be given to one group for 10-15 minutes. Electrodes will be placed over lower abdomen over the painful region. Depending upon the painful area 2 or 4 electrodes will be placed.

In this study high frequency TENS will be used.

 

GROUP B:

 TENS along with  taping will be given to other group. Tape will remain for 24 hrs. Re-Taping will be done if necessary.

For taping the skin should be inspect properly and skin should be clean from debris. A piece of tape 5 cm in width and 7-8 cm in length will be applied right from below navel or in suprapubic region and other piece of tape 10 cm in length will be applied to make a cross shape with the first piece. Rub the tape for proper adhesiveness.


 

 
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