| CTRI Number |
CTRI/2024/03/064302 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Physiotherapy management for pain and cramps in Periods/ Menstruation |
|
Scientific Title of Study
|
Effect of Thermotherapy and Electrical Stimulation in Primary Dysmenorrhea: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raksha Somare Magar |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
8059403414 |
| Fax |
|
| Email |
rakshasomare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Rani |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9034627420 |
| Fax |
|
| Email |
dr.vandanaravi7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Rani |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
HARYANA
125001
India |
| Phone |
9034627420 |
| Fax |
|
| Email |
dr.vandanaravi7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
|
|
Primary Sponsor
|
| Name |
Raksha Somare Magar |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| Dr Vandana |
Health Centre of GJUS&T Hisar |
Health Centre of GJUS&T Room no. 7 and University campus, Hisar. Guru Jambheshwar
University of Science
and Technology
Hisar Haryana
Hisar
HARYANA |
9034627240
dr.vandanaravi7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of GJUS&T |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary Dysmenorrhea
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NMES plus thermotherapy |
Subjects of this group will receive intervention with NMES plus hot pack on lower abdomen on first day of menstruation. on first day of menstruation. Intervention will be of 20 minutes for one day. |
| Intervention |
TENS plus thermotherapy |
Subjects of this group will receive treatment with TENS plus hot pack on lower abdomen on first day of menstruation. Intervention will be of 20 minutes for one day. |
| Comparator Agent |
Thermotherapy |
Subjects of this group will receive intervention with hot pack on lower abdomen on first day of menstruation. on first day of menstruation. Intervention will be of 20 minutes for one day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Nulliparous women
Adult females having regular menstrual cycle
Females experiencing menstrual pain on a severity level of 4 or higher on the VAS scale
|
|
| ExclusionCriteria |
| Details |
Women with gastrointestinal, psychiatric, or autoimmune diseases, as well as other chronic pain syndromes
Women who have given birth and tested positive for pregnancy, undergone pelvic surgery, used intrauterine devices, taken chronic medications including oral contraceptives or antidepressants for at least six months prior to study.
•Displayed signs of secondary dysmenorrhea on ultrasonography
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Menstrual Pain
Sleep Quality |
The outcome will be measured two time i.e. pre and post intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/03/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Primary dysmenorrhea (PD) is defined as menstrual discomfort that is linked to regular ovulatory cycles but does not have a physiological origin or pelvic disease. Adolescents and young adults are most likely to experience it. Despite the fact that primary dysmenorrhea has a significant negative impact on women’s health, many of these women choose not to seek medical attention from a health care professional for primary dysmenorrhea for a variety of reasons, including: believing that symptoms are normal; choosing to manage oneself. For physiotherapy management, mainly TENS is used for intervention. Neuro muscular electrical stimulation is rarely used. So from this study I want to investigate the more suitable and effective way to treat primary dysmenorrhea and to investigate whether the NMES plus thermotherapy is more effective than TENS plus thermotherapy in Primary dysmenorrhea. |