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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   
Secondary IDs if Any  
Secondary ID  Identifier 
MSRMC/ERB/2013  Other 
 
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    
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    
Fax    
Email  veenakiran_nambiar@yahoo.co.in  
 
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  
 
Source of Monetary or Material Support  
MS ramaiah hospitals 
 
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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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. 
 
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 
 
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    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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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