| CTRI Number |
CTRI/2025/08/092770 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the impact of chronic pain on daily life, in patients receiving treatment from a tertiary care pain clinic. |
|
Scientific Title of Study
|
Effect of chronic pain on the daily life of patients receiving treatment from a pain clinic in a tertiary care centre in South India- a cross sectional 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 |
AARCHA S NAIR |
| Designation |
Undergraduate Student |
| Affiliation |
ESIC Medical college and hospital |
| Address |
OPD block, Room no.308, 3rdfloor, ESIC Medical College and Hospital, KK Nagar, Chennai.
Chennai
TAMIL NADU
600078
India |
| Phone |
9940623930 |
| Fax |
|
| Email |
nair.aarcha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. ASWINI L |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ESIC Medical college and hospital |
| Address |
OPD block, Room no.308, 3rdfloor, ESIC Medical College and Hospital, KK Nagar, Chennai.
Chennai
TAMIL NADU
600078
India |
| Phone |
9442011352 |
| Fax |
|
| Email |
aswinijipmer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AARCHA S NAIR |
| Designation |
Undergraduate Student |
| Affiliation |
ESIC Medical college and hospital |
| Address |
OPD block, Room no.308, 3rdfloor, ESIC Medical College and Hospital, KK Nagar, Chennai.
Chennai
TAMIL NADU
600078
India |
| Phone |
9940623930 |
| Fax |
|
| Email |
nair.aarcha@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and hospital, Ashok Pillar Road, KK Nagar, Chennai- 600078, TamilNadu, India. |
|
|
Primary Sponsor
|
| Name |
ESIC Medical College and hospital |
| Address |
Ashok Pillar Road, KK Nagar, Chennai, TamilNadu, India.
Pincode: 600078. |
| 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 |
| DR AARCHA S NAIR |
ESIC Medical college and hospital |
OPD Block, 3rdfloor, Pain clinic , Room no.308, Ashok Pillar Road, KK Nagar, Chennai.-600078.
Chennai
TAMIL NADU |
9940623930
nair.aarcha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Esic medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients having pain for 3 months or more , taking treatment |
|
| ExclusionCriteria |
| Details |
Less than 18 years
Patients with cognitive impairment
Patients with psychiatric disorders
Patients with acute pain
Pregnant and breast feeding patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain scores before and after treatment |
Baseline and at 2 weeks after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between pain intensity & quality of life, using VAS & BPI scores |
At baseline & at 2 weeks after starting treatment |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
20/08/2025 |
| 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="0"
Months="2"
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
|
Identifying predictors of chronic pain is crucial for improving patient care. The study aims to find the differences in pain intensity, interference and quality of life based on pain management methods. The Brief Pain Inventory is expected to show negative impacts of chronic pain on daily life. This study can provide valuable insights into the experience of chronic pain and its impact on the quality of life of the patients. By analyzing the effectiveness of different pain management strategies , it may contribute to improved treatments. Identifying demographic factors and factors influencing quality of life outcomes can inform the development of targeted interventions and support services for diverse patient populations. |