| CTRI Number |
CTRI/2021/03/031838 [Registered on: 09/03/2021] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| 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
|
Effectiveness of physical therapy intervention on primary painful menstrual cycle. |
|
Scientific Title of Study
|
Effectiveness of Non-Invasive Intervention on Anterior Uterocervical Angle in Primary Dysmenorrhea Patients: A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U111112653764 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vandana Esht |
| Designation |
Associate Professor |
| Affiliation |
MMIPR |
| Address |
Maharishi Markandeshwar (Deemed to be university), Maharishi Markandeshwar Institute of Physiotherapy and Rehablitation (MMIPR), room no- 37, Ambala, Haryana
Ambala
HARYANA
133203
India |
| Phone |
8059930235 |
| Fax |
|
| Email |
vandanaesht@mmumullana.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunita Sharma |
| Designation |
Assitant Professor |
| Affiliation |
MMIPR |
| Address |
Maharishi Markandeshwar (Deemed to be university), Maharishi Markandeshwar Institute of Physiotherapy and Rehablitation (MMIPR), Ambala, Haryana
Ambala
HARYANA
133203
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Sunita Sharma |
| Designation |
Assitant Professor |
| Affiliation |
MMIPR |
| Address |
Maharishi Markandeshwar (Deemed to be university), Maharishi Markandeshwar Institute of Physiotherapy and Rehablitation (MMIPR), Ambala, Haryana
Ambala
HARYANA
133203
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Deemed to be university |
| Address |
Maharishi Markandeshwar (Deemed to be university), Maharishi Markandeshwar Institute of Physiotherapy and Rehablitation (MMIPR), Ambala, Haryana |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sunita Sharma |
Maharishi Markandeshwar (Deemed to be university), Maharishi Markandeshwar Institute of Physiotherapy and Rehablitation (MMIPR), Ambala, Haryana |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sunita Sharma |
Maharishi Markandeshwar Hospital |
Maharishi Markandeshwar hospital outpatient department, Musculoskeletal Physiotherapy research lab, room no-B 30, Mullana, Ambala, Haryana
Ambala
HARYANA |
9467633734
drsunita.sharma@mmumullana.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHARISHI MARKANDESHWAR (DEEMED TO BE UNIVERSITY), INSTITUTIONAL ETHICS COMMITTEE, MULLANA, AMBALA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M60-M63||Disorders of muscles, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy including (deep breathing exercise, music therapy, core strengthening, stretching exercise) |
A conventional intervention will be provided for 4 months, 2days before the date of menstruation with1week of protocol every month. |
| Intervention |
Manual therapy including (uterus manipulation, cranial electric stimulation, deep breathing, music therapy, stretching of hamstring muscle, quadriceps, quadratus lumborum muscle, core strengthening)
|
4 months, starting 2 days before the expected date of menstruation, and 1 week of protocol will be provided every month along with a home exercise program |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
I. Medical, Physiotherapy and Nursing female students of regional medical university.
II. Age group 18-35 years
III. Willing Participants
IV. Participants were diagnosed with primary dysmenorrhea according to pathos-physiology of dysmenorrhea.
|
|
| ExclusionCriteria |
| Details |
I. Hypertension, Diabetes, any other chronic disease
II. Secondary Dysmenorrhea.
III. Any Neurological and Cardiological disorder.
IV. Irregular periods
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic ultrasound |
it will be measured prior and after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| International physical activity questionnaire, Depression anxiety scale (DASS21), and Visual Analogue scale (VAS). |
it will be measured prior and after intervention |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2021 |
| Date of Study Completion (India) |
24/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
24/11/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Dysmenorrhea is a common problem in females which causes pain in the lower abdomen and lower back, cramp in thighs and give rise to stress, anxiety, and depression. So in primary dysmenorrhea girls lose their quality of life. Purpose: The purpose of this study is to compare the effect of quality of life and the improvement of pain along with evidence based tool (diagnostic ultrasound). Material and Methods: Participants of primary dysmenorrhea of age between 18-35 years will be recruited based on selection criteria by the purposive sampling method. All participants will be randomly allocated into 2 groups, group A (experimental group 1) and group B(Comparison group 2) All participants will be assessed at baseline with outcome measures of quality of life, improvement of pain, vas, depression scale, and diagnostic ultrasound. Duration of interventions would be 25 days during menstruation cycle treatment shall be provided 2 days before and during the menstrual cycle so that is a 1-week protocol 2days before the menstrual cycle and 5days during menstrual cycle. |