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CTRI Number  CTRI/2024/06/068697 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 10/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Central sensitisation impact on Posture, Stability and walking in people with non-specific chronic low back pain  
Scientific Title of Study   Influence of Central sensitisation on posture, stability and walking among individuals with non-specific chronic low back pain 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manasa kolekar  
Designation  Post graduate student 
Affiliation  Nitte deemed to be university 
Address  Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  6362314978  
Fax    
Email  manasarajendrakolekar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nityal Kumar Alagingi 
Designation  Assistant Professor 
Affiliation  Nitte deemed to be university 
Address  Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7760547669  
Fax    
Email  nityalkumar2020@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Nityal Kumar Alagingi 
Designation  Assistant Professor 
Affiliation  Nitte deemed to be university 
Address  Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7760547669  
Fax    
Email  nityalkumar2020@nitte.edu.in  
 
Source of Monetary or Material Support  
Nitte Institute of Physiotherapy ( NITTE DEEMED TO BE UNIVERSITY) 
 
Primary Sponsor  
Name  Nitte Institute of Physiotherapy NITTE DEEMED TO BE UNIVERSITY 
Address  Nitte institute of physiotherapy deralkatte, mangaluru, karnataka, India 575018  
Type of Sponsor  Other [Constituent colleges of NITTE Deemed to be university] 
 
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 Nityal Kumar Alagingi   K S Hegde hospital   Department of physiotherapy, room no 20, second base division, Nitte institute of physiotherapy NITTE deemed to be university dakshina karnataka
Dakshina Kannada
KARNATAKA 		 7760547669

nityalkumar2020@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of NITTE Institute of Physiotherapy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  non-specific low back pain 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Male and female of 18 – 25 years of age who are having non- specific low
2. back pain Low back pain Individuals are screened under the basis of their symptom and
3. radiological findings (history of at least more than 2month has to be
considered)
4. Low back pain of a non-specific and chronic nature 
 
ExclusionCriteria 
Details  ndividuals who underwent surgery with duration of less than one month
1. History which is exceeded more than 3 months
2. Malignancy, inflammatory joint and bone disease
3. Presence of neurological signs (e.g., perceived weakness in the lower limbs)
4. A diagnosed psychiatric disorder or severe cognitive impairment 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1) FLEXI CURVE
 		 the readings of flexi CURVE will be noted to evaluate posture after recruitment of samples at the first week and second week of the study
 
 
Secondary Outcome  
Outcome  TimePoints 
balance test- multi directional reach test
2-D gait analysis  		 post diagnosis tests will be done once.
1st week of post diagnosis 
 
Target Sample Size   Total Sample Size="87"
Sample Size from India="87" 
Final Enrollment numbers achieved (Total)= "87"
Final Enrollment numbers achieved (India)="87" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) 28/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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   People with chronic low back pain are more sensitive to external cues and have varying degrees of pain, which might interfere with their ability to perform physically and engage in varied activities.[3] Patients with low back discomfort have reported swaying more in their bodies. Although the exact etiology of low back pain is unknown, research has shown that posture is a sign of sensory-motor control.[5] A variety of methods have been used to evaluate changes in motor variability in individuals with LBP, including measuring the variability of kinetic and kinematic parameters, "coordinative" elements of a movement pattern, and muscle activity patterns.Many people think that non-specific low back discomfort is related to movement and posture. Instead of being a position, posture is a complicated pattern of behaviors, reflexes, and adaptive reactions to anything that defies and resists being useful or upright. 
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