| CTRI Number |
CTRI/2023/06/053452 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
30/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To analyze the influence of scapular stabilizers on chronic lateral epicondylitis in diabetic population |
|
Scientific Title of Study
|
To analyze the influence of scapular stabilizers on chronic lateral epicondylitis in diabetic population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIDYA RAJ K |
| Designation |
PG STUDENT |
| Affiliation |
sri ramachandra instituion of higher education and research, faculty of physiotherapy |
| Address |
SRIHER, physiotherapy OP Departement,1 , sri ramachandra nagar, porur, chennai, tamilnadu, 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9080201156 |
| Fax |
|
| Email |
t0221010@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
GEETHA HARI PRIYA S MPT |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
sri ramachandra instituion of higher education and research, faculty of physiotherapy |
| Address |
SRIHER, Physiotherapy OP department, faculty of physiotherapy, 1, sri ramachandra nagar, porur, chennai, tamilnadu, 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
7358580685 |
| Fax |
|
| Email |
geethaharipriya@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
VIDYA RAJ K |
| Designation |
PG STUDENT |
| Affiliation |
sri ramachandra instituion of higher education and research, faculty of physiotherapy |
| Address |
SRIHER, physiotherapy OPD, faculty of physiotherapy, 1, sri ramachandra nagar, porur, chennai, tamilnadu, 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9080201156 |
| Fax |
|
| Email |
t0221010@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| SRIHER, Faculty of physiotherapy OPD. |
|
|
Primary Sponsor
|
| Name |
VIDYA RAJ K |
| Address |
1, sri ramachandra nagar, porur, chennai 600116 |
| 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 |
| VIDYA RAJ |
Sri ramachandra institute of higher education and research |
Physiotherapy OPD, 1, SRIRAMACHANDRA NAGAR, PORUR, CHENNAI 600116
Chennai
TAMIL NADU |
9080201156
t0221010@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee for student projects |
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 |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Unilateral lateral epicondylitis for more than 3 months.
2) Diabetic individuals with PRTEE score above 50.
3) Positive Passive stretching of extensors (Mill’s sign), Pain at the lateral epicondyle during
maximal volitional contraction (MVC) of the wrist extensors (Cozen’s sign), Pain at the
lateral epicondyle while resisting the extension of the middle digit (Maudsley’s test)
4) Questionnaires Score of quickDASH score above 10%,
5) Both male and female population.
6) Age group: 40-60 years with type 2 diabetes. |
|
| ExclusionCriteria |
| Details |
1) PRTEE score below 50
2) Any upper extremity musculoskeletal disorder and deformities.
3) Neck pain with or without radiculopathy, neurological conditions
4) Shoulder and other arm pathologies.
5) Fracture of the upper extremity,
Open wounds
6) Score of less than 10% on the shortened version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH).
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ELECTROMYOGRAPHY (peak average strength) |
Calculated in baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PUSH PULL DYNAMOMETER,
PRTEE SCALE (BASELINE),
quickDASH SCORE |
calculated in baseline |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
21/06/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [t0221010@sriher.edu.in].
- For how long will this data be available start date provided 04-05-2023 and end date provided 04-05-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
NEED FOR THE STUDY It has been suggested that assessing scapular muscle impairments to evaluate any
weakness should be an important component of the evaluation of individuals with LE.
Since the act of gripping or lifting a weight requires not only gripping action of your
forearm muscles but also the action of the scapular muscles and rotator cuff, it is
reasonable that weakness in these muscles will place more stress on the wrist / forearm
muscles. Several studies have shown that focusing on the position of the scapula with a
proper activation of scapular and rotator cuff muscles increased grip strength and
reduced pain in people with lateral epicondylalgia. Previous studies have reported that a
25-35 % decrease in shoulder and scapular strength in individuals resulted in lateral
epicondylalgia.In a healthy population of throwing athletes, fatigue of the scapular stabilisers has been
shown to produce alterations of elbow kinematics implying that scapular muscle fatigue
could predispose individuals to throwing injuries at the elbow region.
Reported poor long-term outcomes for the nonsurgical management of individuals with
LE suggest a less-than-optimal rehabilitation process. Hence knowledge of scapular
muscle function in a working population of individuals with LE may help to further
refine conservative management of lateral epicondylitis. Objectives/Aims : Aim The purpose of this study is to analyze the influence of scapular stabilizers in patients
with lateral epicondylitis in diabetic population. Objectives
1. To assess and analyze the influence of scapular stabilizers in patients with lateral
epicondylitis in diabetic population.
2. To assess the functional outcome in subjects with unilateral lateral epicondylitis in the
corresponding limb among diabetic population. |