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CTRI Number  CTRI/2024/04/065057 [Registered on: 02/04/2024] Trial Registered Prospectively
Last Modified On: 03/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Low back pain among post menopausal women  
Scientific Title of Study   Efficacy of pilates on lumbago, flexibility and endurance among post menopausal women 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  C Nageswari 
Designation  Professor, Research scholar 
Affiliation  Annamalai University 
Address  Room No B318 third floor, Annamalai University Department of Physiotherapy, Out patient department, Tamil Nadu, nagesmpt@gmail.com
Room No B319 third floor, Annamalai University Department of Physiotherapy, Out patient department, Tamil Nadu, nagesmpt@gmail.com
Cuddalore
TAMIL NADU
608002
India 
Phone  9843073406  
Fax    
Email  nagesmpt@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  C Nageswari 
Designation  Research scholar 
Affiliation  Annamalai University 
Address  Room no B319 third floor, Annamalai University Department of Physiotherapy, Out patient department Tamil Nadu, nagesmpt@gmail.com
Room no B319, third floor Annamalai University, Department of Physiotherapy Tamil Nadu
Cuddalore
TAMIL NADU
608002
India 
Phone  9843073406  
Fax    
Email  nagesmpt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. N. Meena 
Designation  Senior lecturer 
Affiliation  Annamalai University 
Address  Room no 201- second floor, Department of physical medicine and rehabilitation, Annamalai University, Annamalai Nagar, chidambaram, Tamil Nadu
Room no 201- second floor, Department of physical medicine and rehabilitation, Annamalai University, Annamalai Nagar, chidambaram, Tamil Nadu
Cuddalore
TAMIL NADU
608002
India 
Phone  8667420200  
Fax    
Email  easwar8@gmail.com  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  Annamalai University 
Address  Room No 2- 1 A,Second floor, Annamalai University, Annamali Nagar, chidambaram, Cuddalore 
Type of Sponsor  Research institution 
 
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 
Dr Balakrishnan  Shri Indra Ganesan Institute of Medical Science College of Physiotherapy  Room no 2 - 1 A, second floor, Department of physiotherapy, Out patient department, Madurai main road, Tiruchirapalli
Tiruchirappalli
TAMIL NADU 		 8508688840

sigimsphysiotherapyproject@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Post menopausal women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional back care exercises   They are given for 40 minutes weekly thrice for four weeks  
Intervention  Pilates exercises   This exercise is given for 40 minutes weekly thrice for four weeks  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  56.00 Year(s)
Gender  Female 
Details  • Females of age group between 45 to 56 years diagnosed with Menopause
• Post menopausal women experiencing non specific low back pain without a specific identifiable cause.
• Post menopausal women with non specific low back pain experiencing for duration of three months.
• Post menopausal women with severity of pain more than 5 as assessed in Numerical pain rating scale.
• Post menopausal women who have not responded adequately to previous physiotherapy modalities.
• Post Menopausal with functional limitation and decreased ability to perform the work due to low back pain as assessed by Oswetry Disability Index score less than 24.
• Decreased quality of life due to low back pain as assessed by MENQOL Questionnaire score more than 40
 
 
ExclusionCriteria 
Details  • Age more than 57
• Pre Menopausal women
• Women with psychological pain
• Menopause Women diagnosed with Lumbar fractures
• Menopause women who have undergone any Lumbar Surgery
• Stroke, spinal cord pathology.
• Inflammatory joint disease.
• Lumbar spine infection
• Marked osteoporosis, Lumbar spine cancer

• Congestive heart failure, uncontrolled hypertension ,pacemaker, internalized metal stent
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Menopause specific quality of life questionnaire
Numeric pain scale
oswetry disability index 		 Baseline and 3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Over all well being of post menopausal women  Baseline & 3 weeks 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/04/2024 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nagesmpt@gmail.com].

  6. For how long will this data be available start date provided 03-04-2024 and end date provided 24-07-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - na
Brief Summary  

Pilates training is a new emerging concept. we are going to study of giving the pilates training for the post menopausal women having non specific low back pain for post menopausal women and how it is decreasing the lumbago and improving the flexibility and endurance. Post menopausal women having low back pain will be asked to for the informed consent and they will be selected for the two groups. One group will be getting Pilates exercise, another group will be getting conservative back exercises.

 
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