| CTRI Number |
CTRI/2024/11/076838 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Examination of cardiac function ,stress and sleep in patients with Chronic low back pain |
|
Scientific Title of Study
|
Association Between Cardiac Autonomic Function, Stress And
Sleep 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, India
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, India
South
DELHI
110025
India |
| Phone |
9958993486 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Faisal Javaid |
| 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, India
South
DELHI
110025
India |
| Phone |
8899054922 |
| Fax |
|
| Email |
samfayzlfarnanz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for physiotherapy Rehabilitation sciences
Jamia Millia Islamia
New Delhi India 110025 |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Centre for physiotherapy Rehabilitation sciences
Jamia Millia Islamia
New Delhi India 110025 |
| Type of Sponsor |
Other [Central University ] |
|
|
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 Zubia Veqar |
Centre for Physiotherapy and Rehabilitation sciences,Jamia Millia Islamia |
Room No-02, Research lab, Ground floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi- 110025
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Chronic Low back pain patients
Participants having chronic low back pain for more than 3 months.
Age between 18 to 45 years
Both the genders.
NPRS score more than 2 and less than 7 i.e. mild and moderate pain
BMI between 18 to 29.9 kg/m2
Willing to participate in the study
Working knowledge of English
Inclusion criteria for healthy subjects
Participants who are healthy and free from physical illness (not having musculoskeletal disorder and not taking any medications currently).
Age between 18 to 45 years.
Both the gender
BMI between 18 to 29.9 kg/m2
Willing to participate in the study
Working knowledge of English
|
|
| ExclusionCriteria |
| Details |
Conditions or medications that will affect the HRV measurements, such as Hypertension, Diabetes.
Currently using anti-inflammatory, pain-reducing medication on a daily basis, steroids, beta-blockers or antidepressants such as benzodiazepine or any other psychotic drugs which can affect pain, autonomic function and sleep.
Subject with Radiculopathy
Subjects who are already diagnosed with any sleeping disorder
Any associated cardiovascular disease (valvular heart disease, coronary artery disease, recent myocardial infarction 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 having any lifestyle disorders (hypertension, diabetes, hypothyroidism, etc)
Subjects who are involved in major life stress situation, such as during the examination period
Subjects taking heavy caffeine (more than 350 mg/day), alcohol (more than 5 standard drinks per week) or other recreational drugs and intense regular physical exercise
Women who are pregnant
History of any cardiac and spinal, upper limb and lower limb surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cardiac Autonomic Nervous system: Heart rate variability
A) Orthostatic stress test
B) Deep breathing test
C) Cold pressor test
D) Hand grip test (HGT)
|
At day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Stress assessed subjectively
Subjective sleep quality |
At day 1 |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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 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
|
This study will be carried out at the Human performance laboratory and out-patient department, Centre for Physiotherapy and Rehabilitation Sciences (CPRS), Jamia Millia Islamia University, New Delhi, India. The participants in both groups will be recruited based on inclusion and exclusion criteria. Participants will fill questionnaires (PSQI, Cohen’s perceived stress questionnaaire and PROMIS-8 B scale, ) followed by objective assessment of HRV,orthostatic stress test, Hand Grip test,Cold Pressor test. The
HRV will be recorded through a 3-lead ECG in the supine position. The
electrodes will be placed on bony prominences, and depending on the color of
the electrode, white is placed on the right ulnar styloid process, green on the
right medial malleolus, and black on the left medial malleolus. It
has time domains such as mean R-R interval, SDNN, rMMSD and PNN50 and frequency
domains – high frequency (HF), low frequency (LF), and LF/HF. |