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 Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- 1.Pain assessment – VAS Scale
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 25.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Age group: 18-25 years
- •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.
Exclusion Criteria
- •Any medical history for the following: 1.PID, PCOD, Endometriosis, surgery 2.Traumatic injury, diseases in genital organs, abnormal vaginal bleeding.
Outcomes
Primary Outcomes
1.Pain assessment – VAS Scale
Time Frame: 1.Baseline study- Pre-intervention | 2.Post intervention- After 4 weeks from the Baseline reading
2.QOL assessment – DASS 21
Time Frame: 1.Baseline study- Pre-intervention | 2.Post intervention- After 4 weeks from the Baseline reading
3.Dysmenorrhea Symptoms – MDQ
Time Frame: 1.Baseline study- Pre-intervention | 2.Post intervention- After 4 weeks from the Baseline reading
Secondary Outcomes
- 1.ADL(2.QOL)