CTRI

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CTRI Number

CTRI/2025/02/081471 [Registered on: 28/02/2025] Trial Registered Prospectively

Last Modified On:

28/02/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Non-randomized, Multiple Arm Trial

Public Title of Study

A comparative study on the effectiveness of instrument assisted soft tissue mobilization (IASTM) versus Mulligan mobilization with movement (MWM) in alleviating pain, improving range of motion, and reducing functional disability in individuals with frozen shoulder

Scientific Title of Study

A study to compare the effectiveness of instrument assisted soft tissue mobilization (IASTM) and Mulligan mobilization with movements (MWM) on pain, range of motion, and functional disability in subjects with frozen shoulder

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 S Fuzal Ahmed
Designation	PG student
Affiliation	RV COLLEGE OF PHYSIOTHERAPY
Address	Department of musculoskeletal science room No 3 No.CA 2 83 3 9th Main Road 4th Block Jaya Nagar Bengaluru Karnataka Bangalore KARNATAKA 560011 India
Phone	08500622406
Fax
Email	sfuzalahmed@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Paul Daniel V K
Designation	PROFESSOR
Affiliation	RV College of Physiotherapy
Address	No.CA 2 83-3 9th Main Road 4th Block Jaya Nagar Bengaluru Karnataka 560011 Bangalore KARNATAKA 560011 India
Phone	9008173167
Fax
Email	pauldanielvk.rvcp@rvei.edu.in

Details of Contact Person
Public Query

Name	Dr Paul Daniel V K
Designation	PROFESSOR
Affiliation	RV College of Physiotherapy
Address	No.CA 2 83 3 9th Main Road 4th Block Jaya Nagar Bengaluru Karnataka 560011 Bangalore KARNATAKA 560011 India
Phone	9008173167
Fax
Email	pauldanielvk.rvcp@rvei.edu.in

Source of Monetary or Material Support

RV College of Physiotherapy No.CA 2 83 3 9th Main Road 4th Block Jaya Nagar Bengaluru Karnataka 560011

Primary Sponsor

Name	nil
Address	nil
Type of Sponsor	Other []

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Paul Daniel V K	RV college of physiotherapy	Department of Musculoskeletal Sciences Room number 03 Bangalore KARNATAKA	9008173167 pauldanielvk.rvcp@rvei.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
rv institute ethics committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M750\|\|Adhesive capsulitis of shoulder,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Instrument assisted soft tissue mobilization	Procedure: patient was in supine lying Emollient was applied over the pectorals major and minor region and spread using the tool. Surface no 1 of the tool was used over the pectorlis region. Tool was held at an angle of 45 degrees. Sweeping strokes were given along the direction of pectorils major and minor muscles. Treatment time 40 seconds with 20 strokes treatment 4 weeks (total 12 sessions.3 sessions per 4 weeks)
Comparator Agent	Mulligan mobilization with movement	Procedure: patient was in supine lying Emollient was applied over the pectorals major and minor region and spread using the tool. Surface no 1 of the tool was used over the pectorlis region. Tool was held at an angle of 45 degrees. Sweeping strokes were given along the direction of pectorils major and minor muscles. Treatment time 40 seconds with 20 strokes treatment 4 weeks (total 12 sessions.3 sessions per 4 weeks)

Inclusion Criteria

Age From	40.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	Subjects of age group 40-65years 2) Subjects with fresh diagnosis of Frozen shoulder 3) subjects with NPRS score more than six

ExclusionCriteria

Details

Subjects with malignancy or neuromuscular disorders
2) Subjects with recent surgeries
3) Subjects with other shoulder pathologies and injuries
4) Fracture/other trauma of upper limb
5) Conditions contraindicated to manual therapy

Method of Generating Random Sequence

Other

Method of Concealment

Other

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
NPRS Shoulder Pain and Disability Index (SPADI)	Baseline, 4 weeks

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="95"
Sample Size from India="95"
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)

12/03/2025

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

This study compares the effectiveness of Instrument Assisted Soft Tissue Mobilization (IASTM) and Mulligan Mobilization with Movements (MWM) in managing Frozen Shoulder (FS), a condition causing pain, stiffness, and limited mobility. Conducted at RV College of Physiotherapy, and clinics around south banglore the study involves 190 participants divided into two groups receiving either IASTM or MWM therapy for four weeks. Pain, range of motion, and functional disability will be assessed using NPRS, SPADI, and goniometric measurements.The findings will help determine the more effective technique, providing evidence-based recommendations for FS treatment.