| 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
|
|
|
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
|
|
|
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. |