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CTRI Number  CTRI/2017/05/008590 [Registered on: 17/05/2017] Trial Registered Retrospectively
Last Modified On: 18/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Comparison of breathing pattern in people with and without low back pain 
Scientific Title of Study   Comparison of respiratory parameters in participants with and without chronic low back pain 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Supriya Shah 
Designation  Principal Investigator 
Affiliation  Dept. of Respiratory Therapy 
Address  Centre for Sports Science, Medicine and Research,Marena Complex, Manipal University, Manipal
Dept of Respiratory Therapy, School of Allied Health Sciences, Manipal University, Manipal 576104
Udupi
KARNATAKA
576104
India 
Phone  9096963924  
Fax    
Email  dr.supriyashah@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Prabu Raja 
Designation  Guide 
Affiliation  Dept of Respiratory Therapy 
Address  Centre for Sports Science, Medicine and Research,Marena Complex, Manipal University, Manipal
Dept of Respiratory Therapy, School of Allied Health Sciences, Manipal University, Manipal 576104
Udupi
KARNATAKA
576104
India 
Phone  8867591333  
Fax    
Email  prabu.raja@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Mr Prabu Raja 
Designation  Guide 
Affiliation  Dept of Respiratory Therapy 
Address  Centre for Sports Science, Medicine and Research,Marena Complex, Manipal University, Manipal
Dept of Respiratory Therapy, School of Allied Health Sciences, Manipal University, Manipal 576104
Udupi
KARNATAKA
576104
India 
Phone  8867591333  
Fax    
Email  prabu.raja@manipal.edu  
 
Source of Monetary or Material Support  
Dept.Exercise and Sports Science,Marena Complex, Manipal University, Manipal 576104, Karnataka 
 
Primary Sponsor  
Name  Dept Exercise and Sports Science 
Address  Dept.Exercise and Sports Science,Marena Complex, Manipal University, Manipal 576104, Karnataka 
Type of Sponsor  Other [Research Institute and Hospital] 
 
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 
Supriya Shah  Centre for Sports Science, Medicine and Research,  Marena Complex,Manipal University,Manipal-576104
Udupi
KARNATAKA 		 9096963924

dr.supriyashah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital, Manipal Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  With low back pain. Control group - Healthy participants without low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Case:Low back pain on and off for more then 3 months and without any known respiratory disorders.
2. Control:Without any low back pain and without any known respiratory disorders. 
 
ExclusionCriteria 
Details  1. Acute trauma which is causing low back pain, 2. You have undergone any surgery for low back pain in the last two months
3. You have any known heart disease
4. If you are a cigarette/beedi smoker
5. If you may have any known respiratory disorders
6. You are consuming any medications affecting breathing
7. ongoing menstruation. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Maximal Voluntary Ventilation(MVV)and End-tidal carbon dioxide(ETCO2)  Immediate 
 
Secondary Outcome  
Outcome  TimePoints 
End-tidal carbon dioxide(ETCO2)  Immediate
 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/04/2017 
Date of Study Completion (India) 14/05/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 14/05/2017 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Muscles responsible for breathing (primarily diaphragm) are associated with dual function of breathing and spinal control. In case of low back pain, there is inhibition in the normal functioning breathing muscles respiratory alterations as it tries to maintain the intra-abdominal pressure. This relation of dysfunctional breathing with chronic low back pain needs to be explored as there are minimal evidences. This study is aimed to compare respiratory parameters in people with and without chronic low back pain. The study may help to modify and explore new treatment guidelines for treatment of low back pain with associated dysfunctional breathing.

 
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