| CTRI Number |
CTRI/2021/08/035663 [Registered on: 13/08/2021] Trial Registered Prospectively |
| Last Modified On: |
09/06/2024 |
| 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
|
Effect of intramuscluar electrical stimulation of frequency 2Hz and 100 Hz on post dry needling soreness of upper trapezius muscle. |
|
Scientific Title of Study
|
Short term effect of frequency specific intramuscular electrical stimulation on post dry needling soreness of upper fiber of trapezius: a pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarika |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University |
| Address |
MYAS-GNDU Department of Sports Sciences and Medicine, Guru
Nanak Dev University, Amritsar
Amritsar
PUNJAB
143005
India |
| Phone |
9463006005 |
| Fax |
|
| Email |
sarika.myas@gndu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoj Kumar Sharma |
| Designation |
MPT(Sports Physiotherapy) |
| Affiliation |
Guru Nanak Dev University |
| Address |
MYAS-GNDU Department of Sports Sciences and Medicine, Guru
Nanak Dev University, Amritsar
Amritsar
PUNJAB
143005
India |
| Phone |
8860533343 |
| Fax |
|
| Email |
manoj.myas@gndu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Manoj Kumar Sharma |
| Designation |
MPT(Sports Physiotherapy) |
| Affiliation |
Guru Nanak Dev University |
| Address |
MYAS-GNDU Department of Sports Sciences and Medicine, Guru
Nanak Dev University, Amritsar
Amritsar
PUNJAB
143005
India |
| Phone |
8860533343 |
| Fax |
|
| Email |
manoj.myas@gndu.ac.in |
|
|
Source of Monetary or Material Support
|
| Rehabilitation Center, MYAS-GNDU Department of Sports
Sciences and Medicine, Guru Nanak Dev University
Amritsar
Punjab, INDIA |
|
|
Primary Sponsor
|
| Name |
Ministry of Youth Affairs and Sports |
| Address |
Room No. 401, C-Wing, Shastri Bhawan, New Delhi, Delhi 110001 |
| Type of Sponsor |
Government funding agency |
|
|
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 Sarika |
Rehabilitation center |
MYAS-GNDU
Department of Sports
Sciences and Medicine,
Guru Nanak Dev
University
Amritsar
PUNJAB |
9463006005
sarika.myas@gndu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Guru Nanak Dev University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Trigger point in upper fibers of trapezius muscle |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dry Nedling intramuscular electrical stimulation with current of frequency 2Hz and 100Hz. |
10 minutes |
| Comparator Agent |
Trigger Point Dry Needling |
till local twitch responce elicit. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Trigger point in upper fiber of trapezius muscle |
|
| ExclusionCriteria |
| Details |
Hypertension, Cancer, Infection, Autoimmune disorder, Taking anticoagulant medicine or having blood clotting disorder, Metal sensitivity, currently smoking or taking alcohol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Numeric Pain Rating Scale(NPRS)(0-10),
-Pressure pain threshold (PPT)(Kg/cm2) |
Before the Intervention and 24 Hours after the intervention |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2021 |
| Date of Study Completion (India) |
07/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Sharma, Manoj & Chaudhary, Sarika & Shenoy, Shweta. (2024). Short-term effect of frequency specific intramuscular electrical stimulation on post dry needling soreness of upper fibers of trapezius: A randomized controlled trial. Journal of Bodywork and Movement Therapies. 40. 10.1016/j.jbmt.2024.04.003. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
NA |