| CTRI Number |
CTRI/2022/06/043223 [Registered on: 13/06/2022] Trial Registered Prospectively |
| Last Modified On: |
14/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effectiveness of Strengthening exercises and Tai chi program on Low Back Pain and Quality of Life for young female with pain during periods |
|
Scientific Title of Study
|
To Compare the Effectiveness of Strengthening exercises and Tai chi exercises on Low Back Pain and Quality of Life for Young Female with Primary Dysmenorrhea. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikshita Sharan |
| Designation |
MPT (Musculoskeletal)) |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Faridabad
HARYANA
121004
India |
| Phone |
8588865047 |
| Fax |
|
| Email |
sshikshita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka Sethi |
| Designation |
Assistant Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Department of Physiotherapy
Faculty of Allied Health Sciences
Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Department of Physiotherapy
Faculty of Allied Health Sciences
Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Faridabad
HARYANA
121004
India |
| Phone |
9910072370 |
| Fax |
|
| Email |
p.vashista09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Sethi |
| Designation |
Assistant Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Department of Physiotherapy
Faculty of Allied Health Sciences
Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Department of Physiotherapy
Faculty of Allied Health Sciences
Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
HARYANA
121004
India |
| Phone |
9910072370 |
| Fax |
|
| Email |
p.vashista09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna International Institute of Research and Studies, Faridabad |
|
|
Primary Sponsor
|
| Name |
SHIKSHITA SHARAN |
| Address |
HN RZ F22A GALI NO. 33 PRADHAN CHOWKN SADHNAGAR PALAM, N. DELHI |
| 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 |
| Priyanka Sethi |
Department of Physiotherapy |
Manav Rachna International Institute of Research and studies
Faridabad
HARYANA |
9910072370
p.vashista09@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DEPARTMENT OF PHYSIOTHERAPY |
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 |
| Comparator Agent |
CONTROL GROUP WITH GENERALISED EXERCISES FOR 4 WEEKS |
CONTROL GROUP WITH GENERALISED EXERCISES FOR 4 WEEKS |
| Intervention |
STRENGTHENING EXERCISES FOR 4 WEEKS |
STRENGTHENING EXERCISES FOR 4 WEEKS IN GROUP A |
| Intervention |
TAI CHI EXERCISE PROGRAM FOR 4 WEEKS |
TAI CHI EXERCISE PROGRAM FOR 4 WEEKS IN GROUP B |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1. Age group: 18-25 years
2. Pain intensity of 5 or above in VAS
3. Regular menstrual cycle with primary
dysmenorrhea
4. Literate and illiterate young women
5. Willing to participate in study
|
|
| ExclusionCriteria |
| Details |
Any medical history for the following:
1. PID, PCOD, Endometriosis, surgery
2. Traumatic injury, diseases in genital organs, abnormal vaginal bleeding.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain assessment – VAS Scale
2. QOL assessment – DASS 21
3. Dysmenorrhea Symptoms – MDQ
|
1. Baseline study- Pre-intervention
2. Post intervention- After 4 weeks from the Baseline reading
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. ADL
2. QOL
|
1. Baseline study- Pre-intervention
2. Post intervention- After 4 weeks from the Baseline reading
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/06/2022 |
| Date of Study Completion (India) |
07/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
THE STUDY PROTOCOL WAS APPROVED BY THE RESEACH ETHICAL COMMITY- FACULTY OF ALLIED HEALTH SCIENCES, MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES, FARIDABAD. THE STUDY WILL BE DONE IN ACCORANDANCE WITH THE NATIONAL ETHICAL GUIDELINES FOR BIOMEDICAL AND HEALTH RESEARCH INVOLVING HUMAN PARTICIPANTS- INDIAN COUNCIL OF MEDICAL RESEARCH (ICMR) GUIDELINES (REVISED-2017) AND GUIDELINES OF HELINSKI DECLARATION 2013. ALL THE PARTICIPANTS WILL BE MADE TO SIGN THE WRITTEN INFORMED CONSENT PRIOR TO THE PARTICIPATION INTO THE STUDY. THE PARTICIPANTS FROM THE DEPARTMENT OF PHYSIOTHERAPY WILL BE IDENTIFIED. FOLLOWING IDENTIFICATION OF THE PARTICIPANTS MATCHING INCLUSION AND EXCLUSION CRITERIA. A TOTAL OF 109 SUBJECTS, SAMPLING USING RANDOMISATION WILL BE DONE AND THE PARTICIPANTS WILL BE ASSIGNED ALTERNATIVELY INTO THREE GROUPS- 15 SUBJECTS IN CONTROL GROUP, 15 SUBJECTS IN EXPERIMENTAL GROUP A AND 15 SUBJECTS IN EXPERIMENTAL GROUP B. THE EXPERIMENTAL GROUP A WILL BE TREARED WITH THE STRENGTHENING EXERCISE PROGRAM, WHERE AS EXPERIMENTAL GROUP B WILL BE TREATED WITH TAI CHI EXERCISE PROGRAM. THE CONTROL GROUP WILL BE MANAGED WITH GENERALISED EXERCISE PROGRAM. BOTH THE GROUP A AND GROUP B WILL BE TREATED 5 SESSIONS IN A WEEK. POST INTERVENTIONAL READING WILL BE TAKEN AFTER 4 WEEKS POST EXPOSURE OF THE SESSIONS. |