| CTRI Number |
CTRI/2025/07/090439 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Analytical |
| Study Design |
Other |
|
Public Title of Study
|
Creating a New Questionnaire to Measure Chronic Pain and Testing How Accurate and Reliable It Is |
|
Scientific Title of Study
|
Development Of A New Screening Tool For Chronic Pain Assessment And Determination Of Its
Psychometric Properties. |
| 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 Diptee Bhole PT |
| Designation |
HOD and Professor |
| Affiliation |
DES college of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy Department Ground floor,Des Brijlal Jindal collge of Physiotherapy Fergusson college Campus, shiwaji nagar ,Pune
Musculoskeletal Physiotherapy Department Ground floor,Des Brijlal Jindal collge of Physiotherapy Fergusson college Campus, shiwaji nagar ,Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
992375191 |
| Fax |
|
| Email |
dipte.bhole@despune.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Sayli Sunil Munot |
| Designation |
Postgraduate Student |
| Affiliation |
DES College Of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy Department Ground floor,Des Brijlal Jindal collge of Physiotherapy Fergusson college Campus, shiwaji nagar ,Pune
Musculoskeletal Physiotherapy Department Ground floor,Des Brijlal Jindal collge of Physiotherapy Fergusson college Campus, shiwaji nagar ,Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
8381002684 |
| Fax |
|
| Email |
sayalimunot062@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sayli Sunil Munot |
| Designation |
Postgraduate Student |
| Affiliation |
DES College Of Physiotherapy |
| Address |
Musculoskeletal Physiotherapy Department Ground floor,Des Brijlal Jindal collge of Physiotherapy Fergusson college Campus, shiwaji nagar ,Pune
Musculoskeletal Physiotherapy Department Ground floor,Des Brijlal Jindal collge of Physiotherapy Fergusson college Campus, shiwaji nagar ,Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
8381002684 |
| Fax |
|
| Email |
sayalimunot062@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sayli Munot |
| Address |
Gate no. 4, ground floor, Deccan education society, Brijlal Jindal College of Physiotherapy, Ferguson college campus, shivaji nagar, pune, 411004 |
| Type of Sponsor |
Other [self] |
|
|
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 Sayli Munot |
Physiotherapy clinics |
Deccan education society, Brijlal Jindal College of Physiotherapy, Ferguson college campus, shivaji nagar, pune, 411004
Pune
MAHARASHTRA |
8381002684
sayalimunot062@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC DESBJCOP Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with chronic musculoskeletal pain more than 3 months
able to read and
understand English language |
|
| ExclusionCriteria |
| Details |
Individuals diagnosed with psychiatric illness
Coexisting neurologic and oncological conditions causing chronic pain |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intraclass correlation
Cronbachs alpha |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/08/2025 |
| 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 Applicable |
| 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
|
Chronic pain is a significant healthcare issue. Globally, it has been estimated that 1 in 5 adults suffer from pain and that another 1 in 10 adults are diagnosed with chronic pain each year highlighting the necessity for comprehensive and effective evaluation methods to manage its widespread effects. Acute pain may be a sign of a disease or trauma that can be effectively treated.This study aims to develop and test the psychometric properties of a brief, bio psychosocially informed screening tool for chronic pain, addressing a key gap in current practice by offering a balanced, evidence-based approach to pain assessment that encompasses psychological, and social factors. |