跳至主要内容
临床试验/CTRI/2022/06/043223
CTRI/2022/06/043223已完成不适用

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.

SHIKSHITA SHARAN1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年6月13日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
1.Pain assessment – VAS Scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
Female

入选标准

  • 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.

排除标准

  • Any medical history for the following: 1.PID, PCOD, Endometriosis, surgery 2.Traumatic injury, diseases in genital organs, abnormal vaginal bleeding.

结局指标

主要结局

1.Pain assessment – VAS Scale

时间窗: 1.Baseline study- Pre-intervention | 2.Post intervention- After 4 weeks from the Baseline reading

2.QOL assessment – DASS 21

时间窗: 1.Baseline study- Pre-intervention | 2.Post intervention- After 4 weeks from the Baseline reading

3.Dysmenorrhea Symptoms – MDQ

时间窗: 1.Baseline study- Pre-intervention | 2.Post intervention- After 4 weeks from the Baseline reading

次要结局

  • 1.ADL(2.QOL)

研究者

发起方
SHIKSHITA SHARAN
申办方类型
Other [self]

研究点 (1)

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