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CTRI Number  CTRI/2023/04/051888 [Registered on: 24/04/2023] Trial Registered Prospectively
Last Modified On: 21/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Comparison between muscle release technique and Dry needling on pain, grip and hand function in patients with outer elbow pain. 
Scientific Title of Study   Comparison of Myofascial release technique versus Dry Needling on pain, grip strength and functional performance in patients with lateral epicondylitis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mitali Purandare 
Designation  MPT in Orthopedics 
Affiliation  SRM College of Physiotherpy 
Address  SRM college of Physiotherpy, SRM institute of science and technology, kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9579807807  
Fax    
Email  mp1773@srmist.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Yasmeen Imtiaz G 
Designation  Assistant Professor 
Affiliation  SRM college of Physiotherpy 
Address  Staff room, SRM college of Physiotherpy, SRM institute of science and technology, kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9500182105  
Fax    
Email  yasmeeng@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  Yasmeen Imtiaz G 
Designation  Assistant Professor 
Affiliation  SRM college of Physiotherpy 
Address  Staff room, SRM college of Physiotherpy, SRM institute of science and technology, kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9500182105  
Fax    
Email  yasmeeng@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM college of Physiotherpy SRM institute of science and technology, Kattankulathur, Potheri 603203 
 
Primary Sponsor  
Name  Mitali Purandare 
Address  411, VGN Tranquil, Greater Manchester street, Potheri, Kattankulathur, 603203 
Type of Sponsor  Other [self funder] 
 
Details of Secondary Sponsor  
Name  Address 
SRM college of Physiotherpy  SRMIST,SRM college of Physiotherpy, kATTANKULATHUR,603203 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mitali Purandare  SRM COLLEGE OF PHYSIOTHERAPY  Department of physiotherapy, Room no. 6 exercise lab, 4th floor
Kancheepuram
TAMIL NADU 		 9579807807

mp1773@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical college hospital and research center(Institutional Ethical Committe)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Conventional therapy for Group C  Conventional therapy for 3 sessions per week for 4 weeks 
Intervention  Dry needling for Group B  Dry needling for 2 sessions per week for total 5 sessions 
Intervention  Myofascial Release Technique for Group A   Myofascial Release Technique for 3 sessions per week for 4 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Individuals willing to participate.
Positive Mill’s test
Pain intensity between 3 to 6 on NPRS
 
 
ExclusionCriteria 
Details  Individuals not willing to participate in the study.
History of trauma, surgery, acute infections, malignancy, pathology of cervical spine, upper limb dysfunction or systemic disorders.
Individuals taking any other treatment for lateral epicondylitis.
Neurological or neuromuscular impairments, cardiovascular diseases, osteoporosis.
Any deformity of affected elbow or wrist.
Skin conditions like dermatitis, eczema or allergy to stainless steel.
Trypanophobia (Fear of needles)
Hemophilia
Pregnancy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
pain  at baseline and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
grip strength and functional performance  at baseline and 4 weeks 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   25/05/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/05/2023 
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   Not Applicable now 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

TITLE OF THE PROJECT: Comparison of Myofascial Release technique versus Dry Needling on pain, grip strength and functional performance in patients with Lateral Epicondylitis.

NAME AND DEPARTMENT/ADDRESS OF THE INVESTIGATOR/STUDENT WITH COURSE PURSUING:

Purandare Mitali sanjay, MPT in Orthopedics (MPT 1st year), SRM College Of Physiotherapy, SRM institute of science and technology.


NAME OF FACULTY (GUIDE) WITH DESIGNATION  & DEPARTMENT:

Mrs. G. Yasmeen Imtiaz G, Assistant Professor, SRM College Of Physiotherapy, SRM institute of science and technology.


PRIMARY & SECONDARY OBJECTIVES OF THE STIDY: To Compare the effectiveness of Myofascial release versus Dry needling on pain, grip strength and functional performance in lateral epicondylitis patients.

 METHODOLOGY:

 STUDY DESIGN    : Experimental study

 SAMPLE SIZE       : 45

 NO OF GROUPS    : 3

 INCLUSION CRITERIA:

• Age 18- 45 years.

• Both men and women

• Individuals willing to participate.

• Positive Mill’s test

• Pain intensity between 3 to 6 on NPRS

 

EXCLUSION CRITERIA:

·           Individuals not willing to participate in the study.

·           History of trauma, surgery, acute infections, malignancy, pathology of cervical spine, upper limb dysfunction or systemic disorders.

·           Individuals taking any other treatment for lateral epicondylitis.

·           Neurological or neuromuscular impairments, cardiovascular diseases, osteoporosis.

·           Any deformity of affected elbow or wrist.

·           Skin conditions like dermatitis, eczema or allergy to stainless steel.

·           Trypanophobia (Fear of needles)

·           Hemophilia

·           Pregnancy

INTERVENTION: Dry Needling or Myofascial release therapy along with conventional therapy

CONTROL: Cryotherapy, Stretching, Strengthening of wrist extensors, Ultrasound

 DOSAGES OF EXERCISES & FREQUENCY WITH DURATION: 2 sessions per week for total 5 sessions for DN group, 3 sessions per week for 4 weeks for MFR group and 3 sessions per week for total 12 sessions for control group.

 

 

 
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