CTRI Number |
CTRI/2013/05/003634 [Registered on: 13/05/2013] Trial Registered Retrospectively |
Last Modified On: |
11/03/2013 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Randomized, Crossover Trial |
Public Title of Study
|
Pain in Pre menstrual syndrome (PMS) - A physiotherapy appraoch |
Scientific Title of Study
|
Effect of Kinesio taping on pain in healthy females having pre menstrual syndrome(PMS) |
Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
MSRMC/ERB/2013 |
Other |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Veena Kiran Nambiar |
Designation |
Associate Professor |
Affiliation |
department of physiotherapy, M.S.Ramaiah medical college |
Address |
department of physiotherapy, M.S.Ramaiah medical college, MSRIT post, MSR nagar, Bangalore
Dakshina Kannada KARNATAKA 560054 India |
Phone |
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Fax |
|
Email |
veenakiran_nambiar@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
Name |
Veena Kiran Nambiar |
Designation |
Associate Professor |
Affiliation |
department of physiotherapy, M.S.Ramaiah medical college |
Address |
department of physiotherapy, M.S.Ramaiah medical college, MSRIT post, MSR nagar, Bangalore
KARNATAKA 560054 India |
Phone |
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Fax |
|
Email |
veenakiran_nambiar@yahoo.co.in |
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Details of Contact Person Public Query
|
Name |
Veena Kiran Nambiar |
Designation |
Associate Professor |
Affiliation |
department of physiotherapy, M.S.Ramaiah medical college |
Address |
department of physiotherapy, M.S.Ramaiah medical college, MSRIT post, MSR nagar, Bangalore
KARNATAKA 560054 India |
Phone |
|
Fax |
|
Email |
veenakiran_nambiar@yahoo.co.in |
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Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Veena Kiran Nambiar |
Address |
Department of Physiotherapy, MS ramaiah medical college and hospital, MSRIT post, MSR nagar, Bangalore |
Type of Sponsor |
Other [Self] |
|
Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Veena kiran nambiar |
MS ramaiah institutions |
Department of Physiotherapy
M S Ramaiah Medical College and Hospital
MSR Nagar
MSRIT Post Dakshina Kannada KARNATAKA |
919880575407
veenakiran_nambiar@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
MS Ramaiah medical college and hospitals, ethical review board |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Pre menstrual syndrome |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Effect of Kinesio taping on pain in healthy females having pre menstrual syndrome |
50 healthy female subjects with the symptoms of PMS will be selected. The purpose of the study will be explained and an informed consent will be obtained from the subjects. Once the subjects satisfying the inclusion criteria they will be selected and will be asked to fill up the questionnaire i.e. Personal Health Questionnaire Depression scale (PHQ – 9), Fatigue Assessment Scale (FAS) and Visual Analog Scale (VAS) for Pain. Kinesiotaping will be applied and subjects will be advised not to remove the kinesiotape for 24 hours. A 24 hour pain pattern will be recorded on VAS by the subjects. Post 24 hours the subjects will be asked to fill up the FAS and PHQ 9 questionnaire and the results will be compared. |
Comparator Agent |
Effect of sham kinesio taping on pain in healthy females having pre menstrual syndrome |
50 healthy female subjects with the symptoms of PMS will be selected. The purpose of the study will be explained and an informed consent will be obtained from the subjects. Once the subjects satisfying the inclusion criteria they will be selected and will be asked to fill up the questionnaire i.e. Personal Health Questionnaire Depression scale (PHQ – 9), Fatigue Assessment Scale (FAS) and Visual Analog Scale (VAS) for Pain. Kinesiotaping will be applied and subjects will be advised not to remove the kinesiotape for 24 hours. A 24 hour pain pattern will be recorded on VAS by the subjects. Post 24 hours the subjects will be asked to fill up the FAS and PHQ 9 questionnaire and the results will be compared. |
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Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
27.00 Year(s) |
Gender |
Female |
Details |
Healthy female subjects between 18 -27 years, Symptoms of PMS (Somatic and/or Psychosocial) |
|
ExclusionCriteria |
Details |
PCOD (Polycystic ovarian disease), Subjects on any type of medication, Married females, Endometriosis |
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Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Other |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Fatigue Assessment Scale (FAS), PHQ 9(Personal health questionnaire), Visual analogue scale (VAS) |
Day 1 of PMS and After 24 hours reassessment will be done. |
|
Secondary Outcome
|
Outcome |
TimePoints |
none |
none |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/04/2013 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
ABSTRACT Introduction: Pre Menstrual syndrome (PMS), also called as Premenstrual tension (PMT) is used to describe physical, cognitive, affective and behavioural symptoms that occur cyclically during the luteal phase of the menstrual cycle and resolve quickly at or within a few days of the onset of duration.The impact of PMS on women’s daily activity is also huge. The activities reported to be limited were concentration in class (48.3%), college attendance (46%), going out of the home (43.8%), and homework tasks (36%). Limitations of these activities were significantly more frequent among severe cases. In a study in Morocco, menstrual pain was often cited as the main single cause of school absenteeism among adolescent girls. Since pain is an integral part of PMS, it is oftenly disregarded by women. This study reported that about 16% of the students had symptoms which were severe enough for them to be absent from the college. Other studies have shown that the rates of absenteeism from school and work range from 34% to 50 %. Around 40 % of women showed that their ability to perform work was affected. Many studies have shown that kinesiotaping can be used as a treatment method to reduce pain. Studies conducted by P.L. Chen et al, proved that kinesio taping can reduce pain in patients with Patellofemoral pain syndrome. There are few studies which highlights the effect of physical exercise on PMS. Kinesiotaping can also be used in reducing the effects of PMS. The role of kinesiotaping used in PMS is not determined. Therefore, this study has been undertaken to investigate the role of kinesiotaping in PMS for reducing the pain and improving the QOL. Objectives: 1. To assess pain in healthy females with PMS pre and post kinesiotaping. 2. To measure the level of fatigue in healthy females with PMS pre and post kinesiotaping.3.To correlate pain and fatigue in healthy females with PMS pre and post kinesiotaping..Materials and Methods: Study design: Interventional, Study Duration: 6 months, Sample size: 50 (Pilot Study), Cases: Healthy females having premenstrual syndrome. Inclusion criteria 1. Healthy female subjects between 18 -27 years. 2. Symptoms of PMS (Somatic and/or Psychosocial). Exclusion Criteria: 1. PCOD (Polycystic ovarian disease). 2. Subjects on any type of medication. 3. Married females 4.Endometriosis. Methodology: 50 healthy female subjects with the symptoms of PMS will be selected. The purpose of the study will be explained and an informed consent will be obtained from the subjects. Once the subjects satisfying the inclusion criteria they will be selected and will be asked to fill up the questionnaire i.e. Personal Health Questionnaire Depression scale (PHQ – 9), Fatigue Assessment Scale (FAS) and Visual Analog Scale (VAS) for Pain. Kinesiotaping will be applied and subjects will be advised not to remove the kinesiotape for 24 hours. A 24 hour pain pattern will be recorded on VAS by the subjects. Post 24 hours the subjects will be asked to fill up the FAS and PHQ 9 questionnaire and the results will be compared. Application of the tape For dorsal ligaments - Patient stands with the trunk flexed and the tape strip is fixed over S1 with maximum tension. The tape ends are fixed with no tension. For ventral ligament – patient stands with the trunk extended. Vertical tape is fixed above the symphysis with maximum tension and horizontal tape is fixed with maximum tension above the symphysis. The tape ends are fixed without tension. The outcome measures taken to determine the effect will be FAS, VAS and PHQ – 9. Statistical Analysis All the data collected will be summarized in through descriptive statistics in terms of mean, median and standard deviation. Paired t- test will and Wilcoxon test will be used to determine the effectiveness and to find the correlation respectively. Implication of study: The decrease in pain which will be achieved by kinesiotaping would result in improved performance in activity levels among females with PMS.
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