| 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
|
|
|
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
|
|
|
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. |