| CTRI Number |
CTRI/2025/03/082523 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Translating and validating patient rated tennis elbow evaluation questionnaire into tamil |
|
Scientific Title of Study
|
Tamil Language Translation and Validation of the Patient Rated Tennis Elbow Evaluation (PRTEE) Questionnaire |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
karthikeyan A |
| Designation |
Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research,
Faculty of Physiotherapy,
No. 1 Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600 116, India
Chennai
TAMIL NADU
600116
India |
| Phone |
9003360800 |
| Fax |
|
| Email |
t0223013@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hepzibah rubella D |
| Designation |
Assistant professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research,
Faculty of Physiotherapy,
No. 1 Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600 116, India
Chennai
TAMIL NADU
600116
India |
| Phone |
9600009396 |
| Fax |
|
| Email |
hepzibahd@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hepzibah rubella D |
| Designation |
Assistant professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research,
Faculty of Physiotherapy,
No. 1 Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600 116, India
Chennai
TAMIL NADU
600116
India |
| Phone |
9600009396 |
| Fax |
|
| Email |
hepzibahd@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research,
Faculty of Physiotherapy,
No. 1 Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600 116, India. |
|
|
Primary Sponsor
|
| Name |
Karthikeyan A |
| Address |
No. 1 Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600 116, 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 |
| Dr Karthikeyan A |
Sri Ramachandra Institute of Higher Education and Research |
Sri Ramachandra Institute of Higher Education and Research,
Faculty of Physiotherapy,
No. 1 Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600 116, India
Chennai
TAMIL NADU |
9003360800
t0223013@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR STUDENTS PROJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M621||Other rupture of muscle (nontraumatic), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female population age group between 30- 50 years with Lateral Epicondylitis
Pain range between 5 to 9 using VAS
Patients with positive of cozen or Mills test will be included
|
|
| ExclusionCriteria |
| Details |
Patients with referred/radiating pain
Patients with any fractures or impairments in upper extremity
Patients who are not able to independently ambulate
Patients with multiple comorbidities
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Hand grip strength |
Baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cozen or mills test
Dash Questionnaire score |
Baseline only |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/03/2025 |
| 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="0"
Months="3"
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
|
Lateral epicondylitis, also commonly referred to as tennis elbow, describes an overuse injury that occurs secondary to an eccentric overload of the common extensor tendon at the origin of the extensor carpi radialis brevis (ECRB) tendon. The overall prevalence rate of tennis elbow, the incidence increases to 10% between the ages of 30 to 50 years in Indian population. Various screening tools are used for diagnostic purposes but very limited accurate functional disability measures are in practice. The commonly used tools are like DASH but specific to Tennis elbow – PRTEE Questionnaire is used. The author of original (English ) version of PRTEE questionnaire is Joy C. Macdermid et all which was published in November 2005 and validated in 2007. PRTEE has been translated into 12 languages and validated in 8 languages. The Tamil translation has not been done yet. |