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CTRI Number  CTRI/2026/01/100038 [Registered on: 01/01/2026] Trial Registered Prospectively
Last Modified On: 31/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on Digestive, Urinary, and Breathing Symptoms in People with Long-Term Low Back Pain 
Scientific Title of Study   Exploring Gastrointestinal Function, Continence, and Respiratory Patterns in Individuals with Chronic Low Back Pain: A Cross-Sectional Study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tamilarasi S 
Designation  Post Graduate student  
Affiliation  Sri Ramachandra institute of higher education and reeducation  
Address  Room No: 2.2 second floor, Sri Ramachandra faculty of physiotherapy, Sri Ramachandra institute of higher education and research, Porur, Chennai, Tamil Nadu 600116

Chennai
TAMIL NADU
600116
India 
Phone  8754013434  
Fax    
Email  tamilarasi3085@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Soundararajan K 
Designation  Assistant professor 
Affiliation  Sri ramachandra faculty of physiotherapy 
Address  Room No: 2.3 second floor, Sri Ramachandra faculty of physiotherapy, Sri Ramachandra institute of higher education and research, Porur, Chennai, Tamil Nadu 600116

Chennai
TAMIL NADU
600116
India 
Phone  9551163416  
Fax    
Email  soundararajan.k@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Soundararajan K 
Designation  Assistant professor 
Affiliation  Sri ramachandra faculty of physiotherapy 
Address  Room No: 2.3 second floor, Sri Ramachandra faculty of physiotherapy, Sri Ramachandra institute of higher education and research, Porur, Chennai, Tamil Nadu 600116

Chennai
TAMIL NADU
600116
India 
Phone  9551163416  
Fax    
Email  soundararajan.k@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of higher education and research,New Block Physiotherapy OPD,Ground floor,NO 1,sri ramachandra Nagar, Porur, Chennai ,Tamil Nadu ,India-600116  
 
Primary Sponsor  
Name  Sri Ramachandra institute of higher education and research 
Address  No: 1 Sri Ramachandra faculty of physiotherapy, Sri Ramachandra institute of higher education and research, Porur, Chennai, Tamil Nadu 600116 
Type of Sponsor  Research institution 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 
Dr K Soundararajan   Sri Ramachandra G block Physiotherapy OPD   New g block Physiotherapy OPD, Ground floor , Sri Ramachandra Hospital, Sri Ramachandra institute of higher education and research, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU 
9551163416

soundararajan.k@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee For Students project  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age 30-65
2. Patient with back pain more than 3 months
3. Willingness to participate and provide informed consent
4. Both male and female participants 
 
ExclusionCriteria 
Details  1. Severe mental health conditions
2. History of abdominal or pelvic surgeries that could alter the gastrointestinal symptoms or
urological function
3. Neurological condition affecting bladder and bowel function
4.Diagnosed respiratory disorder like COPD Asthma or interstitial lung disease 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Gastrointestinal pain rating scale
Nijimegan questionnire
International consultation on incontinence questionnaire  
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Start back screening tool
Lowback disability index 
Baseline 
 
Target Sample Size   Total Sample Size="424"
Sample Size from India="424" 
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)   20/01/2026 
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="4"
Days="5" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Chronic low back pain (CLBP) is one of the most common health problems worldwide and often affects a person’s daily life and well-being. Recent studies suggest that back pain may not only be linked to muscles and joints but could also be connected to other health issues such as stomach and gut problems, urinary incontinence, and abnormal breathing patterns.The reasons for these links are not yet fully understood. Scientists believe that the nervous system, which connects the brain, gut, and muscles, may play a role. However, only a few studies have looked at how these problems occur together in people with chronic low back pain.This study aims to explore whether people with CLBP also commonly experience gastrointestinal (GI) symptoms, incontinence, and changes in their breathing pattern. To do this, we will use simple questionnaires that ask about stomach issues, urinary symptoms, and breathing difficulties, along with a back pain disability scale.By finding these associations, the research hopes to improve our understanding of how back pain is connected to other health problems. This knowledge could help healthcare providers design better, more holistic treatment approaches that address not just the pain, but also related issues like digestion, bladder control, and breathing.

 

 
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