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CTRI Number  CTRI/2021/11/038156 [Registered on: 22/11/2021] Trial Registered Prospectively
Last Modified On: 16/11/2021
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   Physiotherapy for Elbow pain 
Scientific Title of Study   Role Of High Velocity Low Amplitude (HVLA) Thrust On Improving Hand Grip Strength And Relief Of Pain In Lateral Epicondylalgia(Tennis Elbow) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjali Agarwal 
Designation  Research Scholar 
Affiliation  Era University 
Address  Room No 112, Ground Floor, Paramedical Faculty Department Of Physiotherapy, UPUMS,Saifai, Etawah
Sarfrazganj, Hardoi Road, Lucknow
Lucknow
UTTAR PRADESH
206130
India 
Phone  8604612404  
Fax    
Email  anjaliupums@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr GKSingh 
Designation  HOD, Department of Orthopedics 
Affiliation  Era University 
Address  Era University Lucknow
SARFRAZGANJ, HARDOI ROAD, LUCKNOW
Lucknow
UTTAR PRADESH
226003
India 
Phone  8318038817  
Fax    
Email  drgksingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anjali Agarwal 
Designation  Research Scholar 
Affiliation  Era University 
Address  Room No 112, Ground Floor, Paramedical Faculty Department Of Physiotherapy, UPUMS, Saifai, Etawah
Sarfarazganj, Hardoi Road, Lucknow
Lucknow
UTTAR PRADESH
206130
India 
Phone  8604612404  
Fax    
Email  anjaliupums@gmail.com  
 
Source of Monetary or Material Support  
UPUMS,Saifai,Etawah 
 
Primary Sponsor  
Name  ANJALI AGARWAL 
Address  ROOM NO 112, PARAMEDICAL FACULTY, DEPARTMENT OF PHYSIOTHERAPY, UPUMS, SAIFAI, ETAWAH 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anjali Agarwal  Uttar Pradesh University of Medical Sciences  Physiotherapy OPD
Etawah
UTTAR PRADESH 		 8604612404

anjaliupums@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M771||Lateral epicondylitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy  Deep Tissue friction Massage(DTFM),Hot Therapy, Ultrasound therapy. Three sessions a week on alternative days for 1 week. Total duration of treatment is 1 week. 
Intervention  High velocity Low amplitude Thrust (HVLAT)  three sessions a week on alternative days for 1 week. Total duration of treatment is 1 week.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Age – 30-45 years
2. Sex- Both Male and female.
3. Complaint of local tenderness on palpation over the lateral epicondyle.
4. Positive MILL’s test.
5. Complain of pain with gripping
6. Complain of pain with resisted wrist extension.
7. Complain of pain with passive wrist flexion with the elbow extension.
8. Positive Cozen’s sign
 
 
ExclusionCriteria 
Details  1. No Consent
2. When any of the method of treatment is contraindicated
3. Any other explanation of the pain around elbow
4. Any comorbidity that adversely affect prognosis
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Dynamometer readings for hand grip strength
Pain visual analog scale for pain
Patient rated tennis elbow evaluation scale for severity of symptoms
 		 The measurements are taken at baseline, after 1 week and 3 months Post intervention as follow up.  
 
Secondary Outcome  
Outcome  TimePoints 
Pain is measured by Visual analog scale
Hand grip strength by Hand held dynamometer 		 The measurements are taken at baseline, 1week and 3 months. 
 
Target Sample Size   Total Sample Size="234"
Sample Size from India="234" 
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)   23/11/2021 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

AIMS AND OBJECTIVES OF THE STUDY

AIM: The aim of this study is to find the role of HVLA THRUST on improving hand grip strength and relieving pain in patients with lateral epicondylalgia in comparison to conventional physiotherapy.

This aim will be fulfilled with the help of following objectives:

—  To define the time, place and person distribution of the pathology in the study population.  

—  To determine correlation between pain intensity and hand grip strength.

—  To define the improvement in Pain, hand grip strength in patient with lateral epicondylalgia by HVLAT in comparison to conventional physiotherapy.

 

Ø  MATERIALS AND METHODS

 

—  Place of Study: The study is multi-centered and is conducted at physiotherapy OPD of Uttar Pradesh University of medical sciences, Saifai, Etawah, U.P and physiotherapy OPD of Era University, Lucknow (approximately six months).

—  Duration of Study: Three years.

—  Type of Study: - Randomized clinical control trail.

—  Blinding: Single Blinded (Participant)

—  Sample Size:  A power analysis determined that a total of 117 patients would be required in each group to detect clinically significant changes as statistically significant in terms of improvement in pretreatment pain scores for 80% power at alpha < 0.05. 

—  Study population: The subjects shall be screened and enrolled from the Physiotherapy OPD of UPUMS and Era University after confirmed diagnosis of tennis elbow by orthopedic surgeon.

 

 

 

 

SELECTION OF SUBJECTS AND RANDOMIZATION: 

—  ENROLLMENT: The subjects are screened for eligibility from the OPD of UPUMS, Saifai, Etawah and Era University.

—  RANDOMIZATION: Subsequent Patients will be selected after satisfying the inclusion criteria and consenting. Computerized randomization shall be adopted.

—  ALLOCATION: The patients will be assigned by computerized randomization and allocated to experimental (HVLAT group) or control groups (Conventional physiotherapy).

—  INTERVENTION: Each group is given three sessions per week on alternative days for a week as per the group protocol.

—   FOLLOWUP : The patients are assessed for outcomes after the intervention and 3 months follow up

—  ANALYSIS: The difference in the outcome measures are analysed for statistical significance


 
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