| CTRI Number |
CTRI/2025/04/084103 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pain measurement in chronic pain patients and to correlate with autonomic functions |
|
Scientific Title of Study
|
To study the correlation between changes in baroreflex sensitivity effect and reduction in pain scores during chronic pain management |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruti |
| Designation |
2nd year MBBS student |
| Affiliation |
Government Medical College and Hospital |
| Address |
2nd professional year,E Block , Government Medical College and Hospital, Chandigarh
Chandigarh
CHANDIGARH
160002
India |
| Phone |
9478072576 |
| Fax |
|
| Email |
shrutisinghal031@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vanita Ahuja |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care
Level 5
D Block
Government Medical College and Hospital
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaanupam@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vanita Ahuja |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care
Level 5
D Block
Government Medical College and Hospital
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaanupam@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector-32, Chandigarh,India
Pincode:160030 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Sector 32
Chandigarh
India
Pincode:160030 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Vanita Ahuja |
Government Medical College and Hospital |
PAIN CLINIC
B Block
Sector 32
Chandigarh
CHANDIGARH |
9646121649
vanitaanupam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Chronic pain more than 3 months
VAS more than 3
|
|
| ExclusionCriteria |
| Details |
Not willing to participate
Cancer patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between visual analogue scale (VAS) score and baroreflex sensitivity effect |
Baseline and at 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Demographic profile of patients |
baseline |
| Advanced Bioelectric Impedance Analysis (BIA) measurement |
baseline and at 1 month |
| Record of pain management procedures |
baseline and at 1 month |
| Heart rate variability using ECG |
baseline and at 1 month |
| Blood pressure variability using beat to beat blood pressure |
baseline and at 1 month |
| Any side effects |
baseline and at 1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/04/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Pain patients have sympathetically mediated pain, which remains undetected. Hence the present study will evaluate pain scores and its effect on autonomic functions with change in pain severity in chronic pain patients. |