| CTRI Number |
CTRI/2024/12/077662 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF IASTM FOR PATIENTS WITH TRAPEZITIS
|
|
Scientific Title of Study
|
Additional effects of IASTM on cervical proprioception pain pressure threshold and neck functions in patients with trapezitis A Randomized Control Trial
|
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUDISHA GOSWAMI |
| Designation |
BPT STUDENT |
| Affiliation |
DR.DY. Patil College Of Physiotherapy |
| Address |
DR.DY. Patil College Of Physiotherapy,Orthopaedic Department 3rd Floor Sant Tukaram Nagar Maharashtra 411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
8847771234 |
| Fax |
|
| Email |
deepigoswami4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NEHA KULKARNI PT |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
DR.DY. Patil College Of Physiotherapy |
| Address |
DR.DY. Patil College Of Physiotherapy,Orthopaedic Department 3rd Floor Sant Tukaram Nagar Maharashtra 411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
9922154359 |
| Fax |
|
| Email |
neha.kulkarni@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr NEHA KULKARNI PT |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
DR.DY. Patil College Of Physiotherapy |
| Address |
DR.DY. Patil College Of Physiotherapy,Orthopaedic Department 3rd Floor Sant Tukaram Nagar Maharashtra 411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
9922154359 |
| Fax |
|
| Email |
neha.kulkarni@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| DR.DY. Patil College Of Physiotherapy,Orthopaedic Department 3rd Floor Sant Tukaram Nagar Maharashtra 411018 India |
|
|
Primary Sponsor
|
| Name |
DR.DY. Patil College Of Physiotherapy |
| Address |
DR.DY. Patil College Of Physiotherapy,Orthopaedic Department 3rd Floor Sant Tukaram Nagar Maharashtra 411018 India |
| Type of Sponsor |
Other [Deemed university] |
|
|
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 Neha Kulkarni PT |
DR.DY. Patil College Of Physiotherapy |
DR.DY. Patil College Of Physiotherapy,Orthopaedic Department 3rd Floor Sant Tukaram Nagar Maharashtra 411018 India
Pune
MAHARASHTRA |
9922154359
neha.kulkarni@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR.DY.PatilCollegeOf Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A |
iastm on trapezius muscle and conventional exercises Shoulder elevation 1 set of 10 reps
Shoulder depression 1 set of 10 reps
Shoulder shrugging 1 set of 10 reps
Scapular sets 1 set of 10 reps
Shoulder rotation 1 set of 10 reps
Passive stretching 3reps of 10 sec holds
Static neck stretching 3 reps of 10sec hold with rest 5sec (Alternate days IASTM with every day exercises |
| Comparator Agent |
group B |
Shoulder elevation 1 set of 10 reps
Shoulder depression 1 set of 10 reps
Shoulder shrugging 1 set of 10 reps
Scapular sets 1 set of 10 reps
Shoulder rotation 1 set of 10 reps
Passive stretching 3reps of 10 sec holds
Static neck stretching 3 reps of 10sec hold with rest 5sec
For 1 week |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age 20 to 50 years
Pain moderate 4 to 8 cm on VAS
Both females and males
Jump sign positive on trapezius muscle on palpation
|
|
| ExclusionCriteria |
| Details |
open wounds
MSK Disorders affecting Cervical Spine like Cervical Radiculopathy Vertigo, Cervicogenic Headache, Fractures
Recent surgeries around the Cervical Spine
Active inflammation over the Cervical Spine area
severe neurological condition
pregnancy
sensitive or fragile skin or any other skin diseases
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.VISUAL ANALOG SCALE
2.ALGOMETER pain Threshold Pressure
3.JOINT POSITION ERROR DEVICE
|
At baseline and 1 week post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.CERVICAL RANGE OF MOTION
2.COPENHAGEN NECK FUNCTIONAL DISABILITY SCALE
3.FORWARD HEAD |
At baseline & 1 week post treatment |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
16/12/2024 |
| 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="6"
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
|
|
Brief Summary
|
Title: Additional effects of IASTM on cervical proprioception, pain pressure threshold, and neck functions in patients with trapezitis: A Randomized Control Trial
Objective: To evaluate the effects of Instrument-Assisted Soft Tissue Mobilization (IASTM) on cervical proprioception, pain pressure threshold, and neck function in individuals with trapezitis.
Design: Randomized controlled trial
Participants: 52 adults (ages 20-50) with unilateral trapezitis, assessed for pain intensity, trigger points, and neck function.
Intervention:
Group A (Experimental): IASTM with conventional exercises Group B (Control): Conventional exercises only IASTM will be applied on the trapezius muscle followed by exercises . Outcome Measures:
VAS for pain severity Pressure Pain Threshold (PPT) using an algometer Cervical Proprioception with Joint Position Error Test Copenhagen Neck Functional Disability Scale (CNFDS) for neck function impact Procedure: Participants will be randomly assigned to either group and assessed before and after the treatment. Group A will receive IASTM along with exercises for one week, while Group B will receive only exercises for a week |