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CTRI Number  CTRI/2024/11/076519 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 27/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   An Investigation of Sleep Disturbance In Patients With Chronic Low Back Pain 
Scientific Title of Study   A Polysomnographic Investigation of Sleep Disturbance In Patients With 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  Dr Zubia Veqar 
Designation  Honorary Director and Professor 
Affiliation  Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia 
Address  Room No. 202, second floor, Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi-110025

South
DELHI
110025
India 
Phone  9958993486  
Fax    
Email  veqar.zubia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Zubia Veqar 
Designation  Honorary Director and Professor 
Affiliation  Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia 
Address  Room No. 202, second floor, Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi-110025

South
DELHI
110025
India 
Phone  9958993486  
Fax    
Email  veqar.zubia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Md Furquan 
Designation  Student 
Affiliation  Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia 
Address  Room no. 207, second floor, Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi-110025

South
DELHI
110025
India 
Phone  7065309544  
Fax    
Email  furquanobaid@gmail.com  
 
Source of Monetary or Material Support  
Jamia Millia Islamia,Okhla New Delhi 
 
Primary Sponsor  
Name  Jamia Millia Islamia 
Address  Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia Maulana Md Ali Jauhar Marg ,Okhla New Delhi -110025, India 
Type of Sponsor  Other [Central 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 Zubia Veqar  Centre for Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia   Room No.- 205, second floor, Sleep Lab, Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi 110025, India South DELHI
South
DELHI 		 9958993486

veqar.zubia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Jamia Millia Islamia  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M999||Biomechanical lesion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  Chronic Low back Pain more than twelve weeks and less than seven years

NPRS score of 3-7

participant who are healthy and free from physical illness

Willingness to participate in the present study

Working knowledge of the English language (to fill out the questionnaires and consent form)
 
 
ExclusionCriteria 
Details  They will have a history of low back pain ≥ 7 years, leading to the development of coping with pain skills
more than 50 years of age because of the decrease in slow wave sleep (SWS) that occurs in this age group
Cognitive impairment that would limit their participation
Participant who will be taking heavy caffeine (more than 350 mg/day), alcohol (more than 5 standard drinks per week), or other recreational drugs
Participant who will be performing intense regular physical exercise
Participant dealing with major life stress situations, such as examination preparation, job seeking, etc.
Participant already diagnosed with any sleep disorders
Participant having any lifestyle disorders (hypertension, diabetes, hypothyroidism, etc)
Subjects having chronic secondary musculoskeletal pain (pain due to inflammatory conditions, infections, auto-immune disease, nervous system disease, local structural musculoskeletal changes)
Participant consuming any anti-inflammatory, antidepressant drugs such as benzodiazepine, B-blockers, or any other psychotic drugs that can affect pain, autonomic function, and sleep. Psychological disorders, cognitive impairment for atleast six weeks
Any associated cardiovascular disease (valvular heart disease, coronary artery disease, recent myocardial infarction, etc.)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Objective sleep
Pain intensity
Functional disability
 		 On day 1
 
 
Secondary Outcome  
Outcome  TimePoints 
Subjective sleep quality
Quality of life 		 On Day 1 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/11/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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   The patients will be recruited from the community and the Centre for Physiotherapy and Rehabilitation Sciences(CPRS) clinic, Jamia Millia Islamia on the basis of the inclusion and exclusion criteria. Patients would be required to sign the consent form explaining the rights as research subjects. All the identifying information on the consent form and the demographic data shall be confidential. The assessment of the patient will include demographic data, anthropometric characteristrics and screening for chronic low back pain, following which the patients will be assessed for objective sleep using Polysomnography device, pain using NPRS, quality of life using WHOQOL-BREFF, subjective sleep quality using St. Mary’s Hospital Sleep Questionnaire and functional disability by 10-item Oswestry Disability Index.  
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