| CTRI Number |
CTRI/2024/10/075642 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To check the effect of two Physiotherapy treatment (Integrated Neuromuscular Inhibition Technique and Active Release Technique) on Trapezitis in Smartphone Users
|
|
Scientific Title of Study
|
A study to Evaluate the Immediate Effect of Integrated Neuromuscular Inhibition Technique versus Active Release Technique on Pain and Cervical Range of Motion among Smartphone Users with Trapezitis : An Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Desai Mansi Vrajlal |
| Designation |
Post graduate Student |
| Affiliation |
School of physiotherapy, RK University |
| Address |
Research Department, Room no.207, School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot
Rajkot
GUJARAT
360020
India |
| Phone |
9265998004 |
| Fax |
|
| Email |
mdesai645@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Dhrangu |
| Designation |
Assistant Professor, School of Physiotherapy, RK University |
| Affiliation |
School of physiotherapy, RK University |
| Address |
Research Department, Room
no.207, School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot
Rajkot
GUJARAT
360020
India |
| Phone |
7567538856 |
| Fax |
|
| Email |
swati.dhrangu@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Desai Mansi Vrajlal |
| Designation |
Post graduate Student |
| Affiliation |
School of physiotherapy, RK University |
| Address |
Research Department, Room no.207, School of Physiotherapy, RK University, Kasturbadham Rajkot-Bhavnagar Highway, Rajkot
Rajkot
GUJARAT
360020
India |
| Phone |
9265998004 |
| Fax |
|
| Email |
mdesai645@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot,Gujarat, India, 360020 |
|
|
Primary Sponsor
|
| Name |
School of Physiotherapy RK University |
| Address |
Research Department, Room no.207, School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India, 360020 |
| Type of Sponsor |
Research institution |
|
|
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 Desai Mansi Vrajlal |
RK Physiotherapy Rehabilitation and Research center |
Physiotherapy Department, Room no.1, opposite Meghani rang bhavan, Bhaktinagar circle, Rajkot, Gujarat, India 360002
Rajkot
GUJARAT |
9265998004
mdesai645@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, School of Physiotherapy, RK University. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Active Release Technique in Smartphone Users with Trapezitis |
Active Release Technique can help to reduce Neck pain, spasm and increase Cervical Range of Motion Immediately. It will be given to group-B(30 patients) in form of single session(for 1 day).Treatment duration will be 5 minutes. |
| Intervention |
Integrated Neuromuscular Inhibition Technique in Smartphone Users with Trapezitis |
Integrated Neuromuscular Inhibition Technique can help to reduce Neck pain, spasm and increase Cervical Range of Motion Immediately. It will be given to group-A(30 patients) in form of single session(for 1 day).Treatment duration will be 10 minutes.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Pain intensity of minimum 3 on Numeric Pain Rating Scale.
2.patients having Active trigger point in trapezius.
3.At least 4 hours a day using smartphone in sitting position.
4.Patients having Unilateral Trapezitis more than 3 months.
|
|
| ExclusionCriteria |
| Details |
1.Neurological conditions related cervical region (like; spinal cord injury)
2.Musculoskeletal conditions in/around cervical region (like; Traumatic Neck Injury, Cervical spine fracture, Upper limb fracture, Cervical radiculopathy, Cervical spondylosis etc.)
3.Patients consuming painkillers or steroids.
4.Non-consent/ Non-cooperative subjects.
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale |
Pre and Post (At baseline, immediate after treatment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cervical Range Of motion (Lateral flexion and rotation) |
Pre and Post (At baseline, immediate after treatment) |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
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Brief Summary
|
Title: A Study to evaluate Immediate effect of Integrated Neuromuscular Inhibition Technique versus Active Release Technique on Pain and Cervical Range of Motion among Smartphone Users with Trapezitis: An Interventional Study.
Investigator: Desai Mansi Vrajlal, PG Scholar of RK University.
Background: Neck pain is commonly seen in 70% of the people once in their lives. The most prominent cause of neck pain is poor ergonomics (like, Using Smartphone in sitting position with flexed neck for long time) that will lead to inflammation of trapezius muscle also known as Trapezitis and hence the intent of the study is to find out and compare the effect of Integrated Neuromuscular Inhibition Technique and Active Release Technique in Smartphone users.
AIM: To find out the effectiveness of Integrated Neuromuscular Inhibition Technique versus Active Release Technique on pain and cervical range of motion in Smartphone Users with Trapezitis.
Method: In this comparative study, 60 Smartphone Users will be selected by convenient sampling method according to inclusion and exclusion criteria in between age of 18 to 35 years with Trapezitis. After selection they will be divided into 2 groups where one group will be given Integrated Neuromuscular Inhibition Technique and other group will be given Active Release Technique and immediate effect will be checked by using Numeric Pain Rating Scale for Pain and by Universal Goniometer for Cervical lateral flexion and Cervical rotation For Cervical Range of Motion before and after the treatment. After that the statistical analysis will be done by Ms excel and Statistical Package for the Social Sciences (SPSS).
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