| CTRI Number |
CTRI/2024/07/070661 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of pelvis exercises on pelvic imbalance and jaw pain in women with menstrual pain |
|
Scientific Title of Study
|
Effect of Pelvis Reposition Exercise on Pelvic Asymmetry and Temporomandibular Disorder among 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 |
Neeraja Raj Arayamparambil M R |
| Designation |
Post Graduate student |
| Affiliation |
SRM College of Physiotherapy SRM institute of science and technology |
| Address |
Room no PT05 5th floor
SRM College of Physiotherapy SRM Medical College Hospital and Research center
Potheri SRM Nagar Kattankulathur Chengalpattu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9961267420 |
| Fax |
|
| Email |
neerajaraj610@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S F Mariyam Farzana |
| Designation |
Assistant Professor |
| Affiliation |
SRM College of Physiotherapy SRM institute of science and technology |
| Address |
Room no PT 05 5th floor SRM college of physiotherapy SRM medical college hospital and research center SRM nagar Potheri Kattankulathur Chengalpattu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884654310 |
| Fax |
|
| Email |
mariyamf@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
S F Mariyam Farzana |
| Designation |
Assistant Professor |
| Affiliation |
SRM College of Physiotherapy SRM institute of science and technology |
| Address |
Room no PT05 5th floor SRM college of Physiotherapy SRM medical college hospital and research center SRM nagar potheri kattankulathur chengalpattu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884654310 |
| Fax |
|
| Email |
mariyamf@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM medical college hospital and research center SRM nagar potheri kattankulathur chengalpattu kancheepuram Tamil Nadu India 603203 |
|
|
Primary Sponsor
|
| Name |
Neeraja Raj Arayamparambil M R |
| Address |
Room no PT05, SRM college of Physiotherapy SRM medical college hospital and research center SRM nagar potheri kattankulathur chengalpattu kanchipuram Tamil Nadu India 603203 |
| Type of Sponsor |
Other [SELF] |
|
|
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 S F Mariyam Farzana MPT |
SRM Medical College Hospital and Research Center |
Outpatient Department of Obstetrics and Gynecology
SRM nagar Potheri
Kattankulathur
Chengalpattu 603203
Kancheepuram
TAMIL NADU |
9884654310
mariyamf@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre 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 |
Pelvis Reposition Exercise |
Pelvis reposition exercise will be given for 3 times a week for first week and then a follow up session for second week. A post-test will be conducted at the end of second week. Sessions will resume for the third week for 3 times followed by a follow up session on the 4th week. |
| Comparator Agent |
without pelvis reposition exercise |
patient will be verbally educated about appropriate posture awareness during daily activities, relaxation exercises for pain relief during menstrual cycle |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Women who have been diagnosed with primary dysmenorrhea
WaLIDD score of 1-7 which indicates painful menstruation
Score of 1-19 on the Helkimo index as a diagnostic measure for TMD
Women who have pelvic asymmetry, screened by APECS body posture evaluation |
|
| ExclusionCriteria |
| Details |
Previous history of pelvic surgeries
Previous history of temporomandibular surgeries
Previous history of spine surgeries
Previous trauma or injury to the pelvis or TMJ or both
Musculoskeletal disorders
Other gynaecological conditions- endometriosis, uterine fibroids/endometriomas, adenomyosis, endometrial polyps, pelvic inflammatory disease, PCOS, hormonal disorders
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
WaLIDD Score of 1- 7
Helkimo index with a score of 1 -19
APECS score |
Pre test
Post test (at end of 4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
WaLIDD Score
Helkimo Index
APECS Score |
Immediate post test (at end of 2 weeks) |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/08/2024 |
| 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
|
Participants will be screened according to the inclusion and exclusion criteria. Research objectives will be clearly explained to the participants (n=46) and informed consent will be taken. The participants will be included in the study and will be grouped as Group A (n=23) and Group B (n=23). Pre-test will be conducted for both the groups, after which pelvis reposition exercises will be taught for group A and patient education will be given for group B. The sessions will go on for 3 times a week for the first week after which there will be a follow up session for the 2nd week. For each session, a new exercise will be added. At the end of 2 weeks, an immediate post-test will be taken. Sessions will be resumed on the 3rd week with 3 sessions in a week followed by a follow up session during the 4th week. Post-test will be taken after the 4th week for all the parameters. All the parameters will be subjected to statistical analysis. |