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CTRI Number  CTRI/2024/12/077791 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 02/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Pain severity, Physical Performance, and Quality of life in Individuals with Low Back Pain: A Cross-Sectional Analysis 
Scientific Title of Study   Impact of pain severity on physical performance and quality of life among low back pain subjects: a cross-sectional observational 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  Mr S J GHOKKUL  
Designation  Under graduate  
Affiliation  Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] 
Address  Faculty of Physiotherapy, Room No 4.3, Floor 4, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India.

Chennai
TAMIL NADU
600116
India 
Phone  9092324444  
Fax    
Email  t0121020@sriher.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Soundararajan 
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] 
Address  Faculty of Physiotherapy, Room No 2.3, Floor 2, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India.

Chennai
TAMIL NADU
600116
India 
Phone  9551163416  
Fax    
Email  soundararajan.k@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr K Soundararajan 
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] 
Address  Faculty of Physiotherapy, Room No 2.3, Floor 2, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India.


TAMIL NADU
600116
India 
Phone  9551163416  
Fax    
Email  soundararajan.k@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India. 
 
Primary Sponsor  
Name  Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] 
Address  Faculty of Physiotherapy, Room No 4.3, Floor 4, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Hospital  New Block Physiotherapy OPD, ground Floor , Room No 1, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university], Porur, Chennai-600116, Tamil Nadu, India
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, Faculty of Physiotherapy,Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur, Chennai-600116,Tamil Nadu,India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
Subjects identified with LBP.
Age above 18 years including both men and women. 
 
ExclusionCriteria 
Details  Exclusion criteria:
Healthy people.
People with walking aids.
Subjects who had spinal fractures or surgery.
People who are unable to understand instructions due to cognitive impairment.
Individuals who have a medical impairment that affects their ability to walk.
Pain Score of more than 7 in NRS. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Timed up and go test (TUG)
Health-related Quality of Life(SF-36 questionnaire)
 
At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Numeric rating scale (NRS)  At baseline 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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)   18/12/2024 
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="6"
Days="0" 
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  

BACKGROUND

It’s common for individuals to experience low back pain (LBP) at some point in their lives, which is typically harmless and lasts for a few days or weeks. LBP affects the lumbar region of the spine, located between the hips and the bottom of the ribcage, and is often associated with muscle tension that limits movement. While the prevalence of LBP varies across populations, disability due to back pain is the leading cause of activity limitation for adults under 45 years old and second only to arthritis for those aged 45 to 65 years old. Prevalence refers to the number of individuals in a defined population who have a specific disease or condition at a given time (Jekel J, Elmore J, Katz D. Epidemiology, Biostatistics, and preventative medicine. Toronto, Ontario, Canada: WB Saunders Co;1996: 20-22). In India, the point, annual, and lifetime prevalence rates of LBP were 48% (95% CI 40-56%), 51% (95% CI 45-58%), and 66% (95% CI 56-75%), respectively, with higher rates among females, rural populations, and elementary workers. However, data on LBP prevalence and risk factors are limited in developing countries like India. Therefore, this study aims to fill this gap by investigating the relationship between pain severity and critical outcomes.

AIM: 

To study the pain severity on performance and quality of life in individuals with Low Back Pain.

OBJECTIVE:

Primary objective:

➢  To explore the association between pain severity and physical performance.

Secondary objectives:

➢  To investigate the pain severity on health-related quality of life(HRQoL)

➢  To examine the effect of LBP using SF-36 Questionnaire and Timed up and go Test(TUG)

➢  To analyze the effect of  LBP using the Numeric rating scale(NRS).

Need for the Study:

While previous research has established the impact of LBP on various aspects of well-being, there remains a gap in understanding how pain severity specifically affects physical performance and quality of life. This study seeks to address this gap by examining the relationship between pain severity and these critical outcomes.

Procedure:

 Institutional Ethical Committee, SRIHER will be obtained and the Study will be registered in the Clinical Trial Registry of India. The participants will be screened for eligibility criteria. Once the participant fulfils the inclusion criteria, informed consent will be obtained and all baseline outcome measures will be recorded. The study will measure pain severity in participants using a Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Next, the participant will perform the Timed Up and Go (TUG) test, which involves standing up from a seated position, walking up to 3 meters, returning to the starting point, and sitting down on a chair while the time is recorded. Finally, the participant will complete a set of questionnaires that assess their Health-Related Quality of Life (HRQoL) using a survey similar to the SF-36.


 
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