| CTRI Number |
CTRI/2026/01/101274 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of elbow structure and its relationship with pain, hand strength and function in people with elbow pain |
|
Scientific Title of Study
|
Radiographic analysis of elbow carrying angle and its association with pain severity, grip strength, and manual dexterity among participants with lateral elbow tendinopathy: 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 |
Darishini A |
| Designation |
Post Graduate student |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Room no 1.5,first floor,Sri Ramachandra Faculty of Physiotherapy,Sri Ramachandra
Institute of Higher Education and Research,No.1,Ramachandra Nagar,Porur,Chennai,Tamil
Nadu-600116,India
Chennai
TAMIL NADU
600116
India |
| Phone |
9043719472 |
| Fax |
|
| Email |
t0224001@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 |
Room no 1.4,first floor,Sri Ramachandra Faculty of Physiotherapy,Sri Ramachandra
Institute of Higher Education and Research,No.1,Ramachandra Nagar,Porur,Chennai,Tamil
Nadu-600116, 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 |
Room no 1.4,first floor,Sri Ramachandra Faculty of Physiotherapy,Sri Ramachandra
Institute of Higher Education and Research,No.1,Ramachandra Nagar,Porur,Chennai,Tamil
Nadu-600116, India
Chennai
TAMIL NADU
600116
India |
| Phone |
9600009396 |
| Fax |
|
| Email |
hepzibahd@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Darishini A |
| Address |
Room no 1.5,first floor,Sri Ramachandra Faculty of Physiotherapy,Sri Ramachandra
Institute of Higher Education and Research,No.1,Ramachandra Nagar,Porur,Chennai,Tamil
Nadu-600116,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 |
| Darishini A |
Sri Ramachandra Hospital G block |
No.1 Ground floor, Sri Ramachandra faculty of
physiotherapy, SRIHER, porur, 600116
Chennai
TAMIL NADU |
9043719472
t0224001@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Students Project |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 20 and 60 years
Clinically diagnosed with lateral elbow tendinopathy
Unilateral presentation
Cozens test positive
|
|
| ExclusionCriteria |
| Details |
Previous trauma or fracture around elbow
History of cervical and upper limb injuries
Pregnant women
Bilateral lateral elbow tendinopathy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Elbow carrying angle measured using radiograph(degrees)
|
baseline (single cross-sectional assessment)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Grip Strength (measured using handheld dynamometer) |
baseline (single cross-sectional assessment) |
| Upper limb pain and disability measured using Patient-Rated Tennis Elbow Evaluation (PRTEE) |
baseline (single cross-sectional assessment) |
| Occupational biomechanical workload assessed using the Strain Index |
baseline (single cross-sectional assessment) |
Pain severity measured using Numeric Pain Rating Scale (NPRS)
|
baseline (single cross-sectional assessment) |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
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)
|
03/02/2026 |
| 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="15" |
|
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, or tennis elbow, is a tendinopathy of the common extensor
origin, most frequently involving the extensor carpi radialis brevis,
and is characterized by pain and tenderness over the lateral epicondyle,
especially during gripping and resisted wrist extension. Repetitive wrist extension
and forearm supination, forceful gripping, and sustained or awkward upper limb postures are recognized mechanical contributors, but the condition
reflects a multifactorial process involving mechanical strain, microtrauma, and individual
anatomical predispositions. The
prevalence of lateral elbow tendinopathy in the general population is estimated at 1 to 3 percent, with
peak incidence in adults between 30 and 60 years. Prospective studies and
meta analyses confirm that biomechanical exposure at work significantly
raises the incidence of lateral elbow tendinopathy. The carrying angle is formed between the
humerus and ulna in the extension position of the elbow. It is an anatomical
factor that may influence tendon loading. Radiographic
studies have reported that higher carrying angles in individuals with lateral elbow tendinopathy,
suggesting that altered valgus alignment may increase tensile stress on the extensor carpi radialis brevis origin during gripping activities. Functional impairment in lateral elbow tendinopathy is
commonly quantified through objective grip strength testing using a handheld
dynamometer, and patient reported outcomes such as the Patient Rated Tennis
Elbow Evaluation. Together, these tools capture both mechanical
deficits and perceived disability. The study aims to examine the association
between elbow carrying angle and pain severity, grip strength, and manual
dexterity in individuals with lateral elbow tendinopathy. The findings may help
improve understanding of biomechanical factors influencing pain and functional
limitations in the upper limb. |