| CTRI Number |
CTRI/2024/07/069990 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| 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 clinical trial to study the effects of two different protocol, Instrument assisted soft tissue mobilization and Extracorporeal Shock wave therapy on upper trapezius Active Myofascial Trigger Points in computer users on Pain, Function and Quality of life. |
|
Scientific Title of Study
|
Evaluating the effects of IASTM and ESWT on alleviating Active Myofascial Trigger Points in Upper Trapezius of Computer Users: A focus on Pain Relief, Enhanced Function and Quality of life Improvement. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abdur Raheem Khan |
| Designation |
Head And Professor Department Of Physiotherapy |
| Affiliation |
Integral University |
| Address |
Department Of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow, 226026
Lucknow
UTTAR PRADESH
226026
India |
| Phone |
9616739965 |
| Fax |
|
| Email |
abdurraheem@iul.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdur Raheem Khan |
| Designation |
Head And Professor Department Of Physiotherapy |
| Affiliation |
Integral University |
| Address |
Department Of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow, 226026
Lucknow
UTTAR PRADESH
226026
India |
| Phone |
9616739965 |
| Fax |
|
| Email |
abdurraheem@iul.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Kanchan Kumari |
| Designation |
Master Of Physiotherapy (MPT) |
| Affiliation |
Integral University |
| Address |
Department Of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow, 226026
Lucknow
UTTAR PRADESH
226026
India |
| Phone |
9721497282 |
| Fax |
|
| Email |
kanchanjaiswal99199@gmail.com |
|
|
Source of Monetary or Material Support
|
| Integral University, Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Abdur Raheem Khan |
| Address |
Department Of Physiotherapy Integral University Dasauli Kursi Road Lucknow 226026 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Kanchan Kumari |
Department Of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow, 226026 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abdur Raheem Khan |
Integral Institute of Medical Science and Research |
Department Of Physiotherapy, Integral University, Dasauli, Kursi Road, Lucknow, 226026
Lucknow
UTTAR PRADESH |
9616739965
abdurraheem@iul.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Integral University, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Computer Users Population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ESWT Group-B |
The patient will be instruct to lie in the supine position on a plinth to reduce upper trapezius activity, The treatment area will sufficiently exposed and a coupling gel will be apply, The handheld transmitter head will be applied to the treatable area, slight pressure will be apply with circular movements to treat trigger points, when it will be stop, coupling gel will wipe off with cotton, 2.0 bars at 15 Hz for 2000 pulses/session, 2days/week for 4 weeks, total 8 sessions. Total duration of intervention will be 10-15 minutes in each setting.
|
| Intervention |
IASTM Group-A
|
Patient of this group will be receive treatment with a stainless steel blade for upper trapezius, before treatment stainless steel blade will be clean with sanitizer, The individual will be sat comfortably on a stool with their forehead resting on their forearm, which will be placed on a table in front of them, Before treatment a lubricant (Vaseline) will be apply to the skin around neck area, Stainless steel blade will be position at 45° on painful trigger points, slow strokes will be apply for about 3-5 minutes along the muscle’s origin to insertion, The strokes will be run in a direction parallel to muscle fibers, Patients who feel a burning sensation after the session will be advice to use an icepack on the treated area. 3 to 5 min/session, 2 days/week for 4 weeks, total 8 sessions. Total duration of intervention will be 10-15 minutes in each setting.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Presence of two active trigger points in the Upper trapezius,
Computer Users,
Jump sign during palpation,
Aged between 20 to 40 years.
|
|
| ExclusionCriteria |
| Details |
Fibromyalgia,
History of whiplash injury,
History of head, neck, cervical spine or shoulder surgery,
History of cervical Radiculopathy or Myelopathy,
History of Cancer,
Any Contraindications of IASTM & ESWT techniques,
Taking any other medications and Physical Therapy,
Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analog Scale,
Neck Disability Index,
Short Form-36 |
At baseline, at 4th week and 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
Modification(s)
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/07/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This Study is a Randomized, Double Blind, Parallel group, Single Center trial comparing the effect of IASTM ( 3-5 min/session, 2 days/week for 4 weeks) and ESWT (2000 pulses/session, 2 days/week for 4 weeks) on alleviating active myofascial trigger points in upper Trapezius of computer users with pain relief, enhanced function, and quality of life improvement, that will be conducted in single center, Integral University, Lucknow (India), the primary outcome measure will be VAS, NDI and SF-36 at baseline , after 4 weeks and after 6 weeks. |