| CTRI Number |
CTRI/2024/03/063505 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
02/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Radiation Therapy
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of laser therapy in elbow pain using ultrasound scan |
|
Scientific Title of Study
|
“Effects of low intensity laser therapy with deep friction massage on tendon thickness and strength in individuals with lateral elbow pain - an ultrasonographic analysis.†|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yuvashree D S |
| Designation |
MPT Orthopaedics and Traumatology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Floor 2, Sri Ramachandra Faculty of Physiotherapy.
Sri Ramachandra Institute of Higher Education and Research.
No.1, ramachandra nagar, porur, chennai-116
Chennai
TAMIL NADU
600116
India |
| Phone |
9962521111 |
| Fax |
|
| Email |
t0222001@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr. Subbiah.K |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room no 2.1, Floor 2, Sri Ramachandra Faculty of Physiotherapy.
Sri Ramachandra Institute of Higher Education and Research.
No.1, ramachandra nagar, porur, Chennai-600116.
Chennai
TAMIL NADU
600116
India |
| Phone |
9443033118 |
| Fax |
|
| Email |
subbiah@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr. Subbiah.K |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room no 2.1, Floor 2, Sri Ramachandra Faculty of Physiotherapy.
Sri Ramachandra Institute of Higher Education and Research.
No.1, ramachandra nagar, porur, chennai-116.
Chennai
TAMIL NADU
600116
India |
| Phone |
9443033118 |
| Fax |
|
| Email |
subbiah@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Faculty of Physiotherapy.
Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-600116 |
|
|
Primary Sponsor
|
| Name |
Yuvashree D S |
| Address |
Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, 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 |
| Dr Yuvashree D S |
Sri Ramachandra Institute of Higher Education and Research |
New Block Physiotherapy OPD, ground Floor, Room No 1, Faculty of Physiotherapy, Sri
Ramachandra Institute of Higher Education
and Research, Porur, Chennai-600116
Chennai
TAMIL NADU |
9962521111
t0222001@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Students Projects, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-600116 |
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 |
Low intensity laser therapy with deep friction massage |
According
to WALD recommendations for 780-860nm, minimum area/points used is 1-2 cm2, 4 Joules,
maximum 100mW/cm2 will be considered as a dosage protocol.
Duration of intervention : 1 week |
| Comparator Agent |
Therapeutic ultrasound and conventional exercises |
parameters :
frequency : 3 MHz
mode : pulsed/continuous
intensity : 0.3-0.5 w/cm2
duration : 8 mins.
Duration of intervention : 1 week |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with the age of 25-60 years of both genders with symptomatic unilateral lateral elbow pain.
2. Patients who have sufficient cognition and communication skills to understand the nature of
study.
3. Patients with positive cozen’s test and reduced grip strength are taken for the study |
|
| ExclusionCriteria |
| Details |
1. Upper extremity surgical treatment history
2. Cubital tunnel syndrome
3. Rheumatoid disease
4. Cervical radiculopathy
5. Major psychiatric disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PRTEE (Patient Rated Tennis Elbow Evaluation), ultrasonography |
Before and after 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| numeric pain rating scale, patient rated tennis elbow evaluation questionnarie, handheld dynamometer, pressure algometer |
1 week |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
12/03/2024 |
| 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="6"
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
|
Procedure : A Randomized controlled trial will be conducted in patients with lateral epicondylitis. The
patients will be taken from patient attending Physiotherapy OPD in Sri Ramachandra Hospital.
Individuals with lateral epicondylitis of both gender, an age between 25 to 60 years of age will be
recruited for the study. The individuals were selected based on the inclusion and exclusion criteria
among patients with unilateral lateral epicondylitis. The participants will be divided into two
groups, experimental and control groups and pre-test on pain, grip strength, tendon thickness will
be taken. Experimental group will receive low intensity laser therapy and deep friction massage
whereas control group will receive therapeutic ultrasound and conventional exercises. According
to WALD recommendations for 780-860nm, minimum area/points used is 1-2 cm2, 4 Joules,
maximum 100mW/cm2 will be considered as a dosage protocol. The post test of the outcomes
will be measured and the statistical significant difference will be analyzed between both the
groups. |