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CTRI Number  CTRI/2023/11/060306 [Registered on: 29/11/2023] 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   Connection Of Heart Function and Sleep in Neck Pain Person and Healthy Person 
Scientific Title of Study   Association between Heart Rate Variability and Sleep among subjects with Chronic Neck Pain and Healthy Controls - A Case-control 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  Dr Zubia Veqar 
Designation  Honorary Director 
Affiliation  Jamia Millia Islamia University 
Address  Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia NEW DELHI 11OO25 India

New Delhi
DELHI
110025
India 
Phone  9958993486  
Fax    
Email  zveqar@jmi.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Zubia Veqar 
Designation  Honorary Director 
Affiliation  Jamia Millia Islamia University 
Address  Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia NEW DELHI 11OO25 India

New Delhi
DELHI
110025
India 
Phone  9958993486  
Fax    
Email  zveqar@jmi.ac.in  
 
Details of Contact Person
Public Query  
Name  Al Afshan 
Designation  Postgraduate Student 
Affiliation  Jamia Millia Islamia University 
Address  Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia NEW DELHI 11OO25 India

New Delhi
DELHI
110025
India 
Phone  7827879954  
Fax    
Email  03alafshan@gmail.com  
 
Source of Monetary or Material Support  
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia University 
 
Primary Sponsor  
Name  Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia University 
Address  Maulana Jauhar Ali Marg, Jamia Nagar, New Delhi- 110025 
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  Room no. 202, Centre for Physiotherapy and Rehabilitation Sciences, Gate No. 8, Jamia Millia Islamia, Maulana Ali Jauhar Marg, Jamia Nagar, New Delhi 110025
New Delhi
DELHI 		 9958993486

zveqar@jmi.ac.in 
 
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 
Healthy Human Volunteers  Healthy 
Patients  (1) ICD-10 Condition: G892||Chronic pain, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  FOR CASES
Chronic non-radicular neck pain lasting more than 6 months
Age between 18 and 45 years, regardless of their sex
NPRS score greater than 2 and less than 7, i.e., mild and moderate pain
Willing to participate in the study
Working knowledge of English (had to complete the questionnaires in English).

FOR CONTROLS
Aged between 18 and 45, regardless of sex
Subjects who are healthy and free from physical illness (not having any musculoskeletal pain disorder and not taking any medications currently)
Willing to participate in the study
Working knowledge of English (have to fill the questionnaires in English)

 
 
ExclusionCriteria 
Details  H/O any cardiac, spinal, upper limb and lower limb surgery
Had CNP ≥ 7 years, which lead to development of coping with pain skills
Women who are pregnant and those who are diagnosed with any gynaecological conditions (polycystic ovarian syndrome, dysmenorrhoea, regular contraceptive pills intake, menopause)
Cognitive impairment that would limit their participation
Subjects taking heavy caffeine (> 350 mg/day), alcohol (>5 standard drinks per week) or other recreational drugs and intense regular physical exercise
Subjects who are involved in major life stress situation, such as during the examination period
Subjects who are already diagnosed with any sleep disorders
Subjects having any lifestyle disorders (hypertension, diabetes, hypothyroidism, etc)
Subjects who are considered having chronic secondary musculoskeletal pain (pain due to inflammatory conditions, infections, auto-immune disease, nervous system disease, local structural musculoskeletal changes)
Subjects using anti-inflammatory, antidepressant drugs such as benzodiazepine, B-blockers, or any other psychotic drugs which can affect pain, autonomic function, and sleep.
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 
sleep quality measured by polysomnography
cardiac autonomic function measured by Heart rate variability
pain intensity measured by NPRS
disability assessed by neck disability index
 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life assessed by WHOQOL-BREF
Subjective sleep quality assessed by Pittsburgh sleep quality index (PSQI)
Pain pressure threshold measurement (PPT measurement) by pressure algometer
Sleep related quality of life assessed by Pittsburgh insomnia rating scale (PIRS)
 		 baseline 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/12/2023 
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 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   Introduction: The literature provides evidence for an association between disturbed sleep and chronic neck pain. Psychological factors (such as depression and anxiety) act as a mediating factor between sleep and pain. Autonomic dysregulation is another important consequence of chronic pain. their is an association between sleep quality and HRV, but only a limited number of studies have explored it.
 objective of the study; to identify whether any direct association exists between heart rate variability and sleep quality in subjects with chronic neck pain and healthy controls (HCs) and to compare the differences in heart rate variability and sleep quality in subjects with CNP and HCs. 

Methodology; The study will employ case control design (n=38), recruiting subjects in 2 groups – subjects with CNP (n=19) and age- and sex- matched HCs (n=19), based on inclusion and exclusion criteria. Data collection will include HRV, Polysomnography, PPT measurement and self-reported measures (NPRS, NDI, PSQI, WHOQOL-BREF, PIRS). Statistical analysis will be done using correlational analysis and group comparisons.

Conclusion and clinical implication; Result from this study may provide evidence of association between HRV and sleep in subjects with CNP, help in understanding the underlying mechanism, highlighting the importance of addressing sleep disturbance in pain management strategies. Thus, contributing to development of interventions to improve sleep for better treatment outcomes and quality of life

 
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