| CTRI Number |
CTRI/2024/10/075461 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exploring the effectiveness of Cyriax physiotherapy versus a supervised exercise program for treating pain, grip strength, and functional performance in cases of Lateral Epicondylitis.
|
|
Scientific Title of Study
|
Comparison of Cyriax Physiotherapy versus supervised exercise program on pain, grip strength and functional performance in Lateral Epicondylitis.
|
| 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 Shagun Agrawal |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Department Of Physiotherapy Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9910259583 |
| Fax |
|
| Email |
dean.sahs@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shagun Agrawal |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Department Of Physiotherapy Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
UTTAR PRADESH
203201
India |
| Phone |
9910259583 |
| Fax |
|
| Email |
dean.sahs@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Anmol Jain |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Department Of Physiotherapy Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9717949051 |
| Fax |
|
| Email |
jainanmol0812@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
| Type of Sponsor |
Research institution |
|
|
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 |
| ProfDr Shagun Agarwal |
OPD ,E003 Physiotherapy Department, Galgotias university |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH |
9910259583
dean.sahs@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M70-M79||Other soft tissue disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cyraix Physiotherapy |
1.deep transverse friction massage for 10 mins (4 session per weeks for 4 weeks).
2.cold pack for 10 min 3.supervised exercise program (static stretching of the Extensor Carpi Radialis Brevis ( duration is 0 to 45 seconds with 6 repetition for 4 weeks)
3. eccentric strengthening of the wrist extensors(4 times per week for 4 weeks).
|
| Comparator Agent |
supervised exercise program |
1.static stretching of the Extensor Carpi Radialis Brevis(0 to 45 second, 6 repetition for 4 weeks. 2.eccentric strengthening of the wrist extensors(4 times per week for 4 weeks).
3.Static stretching was performed in the seated position with elbow extension, forearm pronation, and wrist flexion with ulnar deviation) + cold pack( 10 minutes) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Mill’s/Cozens test- positive |
|
| ExclusionCriteria |
| Details |
Previous surgery to the elbow region.
Cervical radiculopathy.
Corticosteroid injection within 6 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hand Grip Strength Dynamometry |
Hand Grip Strength Dynamometry
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient-Rated Tennis Elbow Evaluation |
4 Week |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/11/2024 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Tennis elbow
(lateral epicondylitis) is swelling of the tendons that bend your wrist
backward away from your palm. Excessive use of the elbow can cause tennis
elbow, sometimes referred to as lateral epicondylitis, a painful ailment marked
by irritation of the tendons connecting the forearm muscles on the outside of
the elbow.(1)
Extensor
muscles, in particular the extensor carpi radialis brevis (ECRB), have been
linked to strong, repetitive wrist movements, according to research. Pain can
range in intensity from mild and sporadic to severe and constant, disrupting
sleep.(2)
A number of
diagnoses, such as tendinosis, epicondylitis, periostitis, tennis elbow, and
extensor carpi radialis brevis (ECRB), are used to characterize pain
surrounding the lateral elbow.(3)
Reduced grip
strength, less functional activities, and greater pain are the main clinical
presentation and chief complaints of tennis elbow, and they may significantly
affect daily living activities. Tennis elbow is an easy diagnosis to make and
can be verified using a test that produces the following symptoms: pain,
palpable soreness over the lateral epicondyle facet, resistance to wrist
extension, resistance to middle finger extension, and passive wrist flexion.(4)
|