FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070991 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 01/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Controlled trail to study the effect of High Voltage Pulsed Galvanic Stimulation in Chronic Lateral Epicondylitis Patients 
Scientific Title of Study   Efficacy of High Voltage Pulsed Galvanic Stimulation on Pain, Grip strength and Function in Subjects with Chronic Lateral Epicondylitis: A Randomized Controlled Trail 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jayashree Panda  
Designation  Post Graduate Student 
Affiliation  National Institute For Locomotor Disabilities(Divyangjan) 
Address  Room Number 117,Department of physiotherapy National Institute for locomotor Disabilities(Divyangjan) BT road, Bonhooghly, Kolkata North Twentyfour Parganas WEST BENGAL 700090 India

North Twentyfour Parganas
WEST BENGAL
700090
India 
Phone  9337650580  
Fax    
Email  jayashree1999p@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bibhuti Sarkar 
Designation  Incharge Lecturer 
Affiliation  National Institute For Locomotor Disabilities(Divyangjan) 
Address  Room Number 117,Department of physiotherapy National Institute for locomotor Disabilities(Divyangjan) BT road, Bonhooghly, Kolkata North Twentyfour Parganas WEST BENGAL 700090 India

North Twentyfour Parganas
WEST BENGAL
700090
India 
Phone  8820692556  
Fax    
Email  sarkarb1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jayashree Panda  
Designation  Post Graduate Student 
Affiliation  National Institute For Locomotor Disabilities(Divyangjan) 
Address  Room Number 117,Department of physiotherapy National Institute for locomotor Disabilities(Divyangjan) BT road, Bonhooghly, Kolkata North Twentyfour Parganas WEST BENGAL 700090 India

North Twentyfour Parganas
WEST BENGAL
700090
India 
Phone  9337650580  
Fax    
Email  jayashree1999p@gmail.com  
 
Source of Monetary or Material Support  
National Institute for locomotor Disablities (Divyangjan), BT Road, Bonhooghly, Kolkata, Pin 700090 
 
Primary Sponsor  
Name  Jayashree Panda 
Address  National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata, West Bengal, Pin 700090 
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 
Jayashree Panda  National Institute for Locomotor Disabilities (Divyangjan)   Room Number 117,Department of Physiotherapy, BT Road,Bonhooghly,Kolkata,West Bengal Pin Code-700090 North Twentyfour Parganas WEST BENGAL
North Twentyfour Parganas
WEST BENGAL 
9337650580

jayashree1999p@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, National Institute for locomotor Disablities (Divyangjan)  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  Controlled Group  Moist hot pack, Standardized exercise program and Home Exercise Program (HEP) with Ergonomic care for 10 sessions (5 sessions per week for 2 weeks).  
Intervention  High Voltage Pulsed Galvanic Stimulation  All the subjects in this group will be treated with High Voltage Pulsed Galvanic Stimulation, Moist hot pack, Standardized exercise program and Home Exercise Program (HEP). Subjects will be given with a voltage of 100v, pulse duration 200 microsecond and frequency of 100 Hz for 10 minutes for 10 sessions.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Both male and female subjects willing to participate in the study.
2. Subjects age group between 30 to 50 years.
3. NPRS score between 3 to 7.
4. Subjects with chronic lateral epicondylitis more than 3 months.
5. Positive response on at least two of the following three provocative tests- Mills test, Cozens test, Maudsleys test
 
 
ExclusionCriteria 
Details  1.Musculoskeletal conditions like Osteoarthritis, Rheumatoid Arthritis, upper limb fracture, deformities, dislocations, myositis ossificans etc.
2.Infectious conditions around elbow like osteomyelitis, septic arthritis etc.
3.Any nerve entrapment syndrome of upper extremity like Pronator teres syndrome, carpal tunnel syndrome, radial tunnel syndrome etc.
4.Neurological conditions like cervical radiculopathy, stroke, reflex sympathetic dystrophy, Parkinson’s disease etc.
5.Recent history of local steroid injection within last three months, or oral steroid medication within last one month.
6.Any local skin disorder and impaired local skin sensation.
7.Red flag sign including a history of carcinoma, etc.
8.Non-co-operative and psychologically unstable subjects
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Pain intensity by Numerical Pain Rating Scale
2.Grip Strength by Hand- held dynamometer
3.Function by Patient Rated Tennis Elbow Evaluation

 
2 times, on Day 0 and after 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/07/2024 
Date of Study Completion (India) 16/06/2025 
Date of First Enrollment (Global)  31/07/2024 
Date of Study Completion (Global) 16/06/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  

PURPOSE OF THE STUDY:

There are very few studies available in which High Voltage Pulsed Galvanic Stimulation shows the efficacy in combination with other technique on reducing pain, improving grip strength and function in subjects with chronic lateral epicondylitis. However, to the best of our knowledge there is no studies which shows the individual efficacy of High Voltage Pulsed Galvanic Stimulation on pain, grip strength and function in subjects with chronic lateral epicondylitis.

Therefore, the purpose of this study is to find out the efficacy of High Voltage Pulsed Galvanic Stimulation on pain, grip strength and function in subjects with chronic lateral epicondylitis.

AIM:

To find out the efficacy of High Voltage Pulsed Galvanic Stimulation on pain, grip strength and function in subjects with chronic lateral epicondylitis.

 OBJECTIVES:

1       To find out the efficacy of High Voltage Pulsed Galvanic Stimulation along with Moist hot pack and Standardized exercise program on pain, grip strength and function in subjects with chronic lateral epicondylitis.

2       To find out the efficacy of Moist hot pack and Standardized exercise program on pain, grip strength and function in subjects with chronic lateral epicondylitis.

3       To compare the efficacy of High Voltage Pulsed Galvanic Stimulation along with Moist hot pack, Standardized exercise program and Moist hot pack, Standardized exercise program alone on pain, grip strength and function in subjects with chronic lateral epicondylitis.

HYPOTHESES

NULL HYPOTHESIS (H0): There is no statistically significant effect of High Voltage Pulsed Galvanic Stimulation on pain, grip strength and function in subjects with chronic lateral epicondylitis.

ALTERNATE HYPOTHESIS (H1): There is statistically significant effect of High Voltage Pulsed Galvanic Stimulation on pain, grip strength and function in subjects with chronic lateral epicondylitis.

PROCEDURE

Approval from the Institutional Ethical Committee (IEC) will be taken before commencement of the study. All subjects having elbow pain or diagnosed with lateral epicondylitis and referred to the department of Physiotherapy from the Assessment clinic (ASC) of NILD will be approached with the proposal of the study. Minimum of 34 subjects with lateral epicondylitis will be assessed and screened according to the inclusion and exclusion criteria. Subjects meeting the exclusion criteria will not be included. Those fulfilling the inclusion criteria will be explained in details about the study in their preferred language.Written Informed consent in their preferred language will be obtained from the subjects agreeing to participate. Then the demographic data will be collected. The subjects will be randomly divided into two groups by using Block randomization method by computer generated random blocks. All the subjects in Group-A (n=17) will be treated with  High Voltage Pulsed Galvanic Stimulation, Moist hot pack, Standardized exercise program and Home Exercise Program (HEP) with Ergonomic care for 10 sessions (5sessions per week for 2weeks). All the subjects in Group- B (n=17) will be treated with Moist hot pack, Standardized exercise  program and Home Exercise Program (HEP) with Ergonomic care  for 10 sessions (5 sessions per week for 2 weeks). After completion of 10 sessions of intervention, all subjects will be adviced to continue HEP.

 The data for Pain by Numerical Pain Rating Scale (NPRS), Pain-free Grip Strength by Hand-held Dynamometer (HHD) and Function by Patient-Rated Tennis Elbow Evaluation (PRTEE) Questionnaire will be taken at the pre intervention and post intervention i.e at the end of 10th sessions (5 sessions per week). Rescue medications duly prescribed by physician will be continued along with the physiotherapeutic approach in both the groups during the study.


 
Close