| CTRI Number |
CTRI/2025/02/080457 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
reliability and validity testing |
| Study Design |
Other |
|
Public Title of Study
|
comparing reliability and validity of individual v/s composite scores in NPRS |
|
Scientific Title of Study
|
Comparative Reliability And Validity Of Individual versus Composite Scoring With Numeric Pain Rating Scale |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nayana Chode |
| Designation |
m.pt student |
| Affiliation |
Manipal Academy of Higher Eduacation |
| Address |
Department of Physiotherapy, Manipal Hospital,
No 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
7777932220 |
| Fax |
|
| Email |
nayanachode@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karvannan H |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital 98, HAL,Old Airport
Road, Bangalore Bangalore KARNATAKA 560017 India 98, Rustam
Bagh, Old Airport Road,
Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Prem |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital 98, HAL,Old Airport
Road, Bangalore Bangalore KARNATAKA 560017 India 98, Rustam
Bagh, Old Airport Road,
Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal academy of higher education, Department of Physiotherapy, Manipal Hospital, No 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport
Road, Bangalore Bangalore KARNATAKA 560017 India Bangalore
KARNATAKA 560017 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Nayana srinivas chode |
manipal hospitals, old hal road |
Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport
Road, Bangalore Bangalore KARNATAKA 560017 India Bangalore
KARNATAKA 560017 India
Bangalore
KARNATAKA |
08141830237
nanu16sept@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethics committee of manipal hospitals, bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
With chronic mechanical neck pain of more than 3 months |
|
| ExclusionCriteria |
| Details |
Individuals with post-traumatic neck pain
Any recent neck surgeries in 3 years
Radiating pain.
Unable to understand Hindi, English, Telugu
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numeric pain rating scale |
6 times within a week before the treatment and 6 times within a week after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
30/03/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 aims to evaluate the
effectiveness of composite pain scoring compared to individual 24-hour recall
ratings and current rating on the Numeric Pain Rating Scale (NPRS) in
individuals with chronic mechanical neck pain undergoing cervical therapeutic
exercises. Current literature has been limited
to a maximum of 4 days of ratings, with limited exploration into extending the
duration of assessment beyond this timeframe There is a need to investigate the impact of extending pain ratings
over a duration of 6 days on the reliability and validity of both individual
and composite scores
|