| CTRI Number |
CTRI/2023/10/058699 [Registered on: 16/10/2023] Trial Registered Prospectively |
| Last Modified On: |
10/10/2023 |
| 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
|
A clinical trial to study effect of Scapula Stabilisation Exercises in patients with frozen shoulder |
|
Scientific Title of Study
|
Effect of Scapula Stabilisation Exercises in patients with Adhesive Capsulitis |
| 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 Yash Vijay Sawant |
| Designation |
MPT Student |
| Affiliation |
Sunanda Diviata School of Science |
| Address |
Department of Physiotherapy ground floor Nanavati Max Super Speciality Hospital LIC Colony Swami Vivekanand Road Vile Parle West
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
8421275900 |
| Fax |
|
| Email |
sawantyash1410@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansi Bhartiya |
| Designation |
Associate Professor - Physiotherapist |
| Affiliation |
Sunanda Diviata School of Science |
| Address |
7th floor, Mithibai building,Sunandan Diviata School of Science SVKM Bhaktivedanta road Vile Parle West
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9867512415 |
| Fax |
|
| Email |
mansi.bhartiya@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Bhartiya |
| Designation |
Associate Professor - Physiotherapist |
| Affiliation |
Sunanda Diviata School of Science |
| Address |
7th floor, Mithibai building,Sunandan Diviata School of Science SVKM Bhaktivedanta road Vile Parle West
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9867512415 |
| Fax |
|
| Email |
mansi.bhartiya@nmims.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Ground Floor Nanavati Max Super Speciality Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Yash Vijay Sawant |
| Address |
Sunandan Divatia school of sciences bhaktivedanta road Vile Parle West |
| Type of Sponsor |
Other [self] |
|
|
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 Ali irani |
nanavati max super specality hospital |
Ground floor, department of physiotherapy, Nanavati max super speciality hospital Vile Parle West
Mumbai (Suburban)
MAHARASHTRA |
022-61347560
physiodept.nanavati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nanavati max super speciality hospital |
Approved |
|
|
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional exercises for adhesive capsulitis |
once in a day for continuous 6 days shoulder exercise will be given |
| Intervention |
scapula stabilisation exercise |
once in a day for continuous 6 days scapula stabilisation exercise will be given in bridging position. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
both males and females diagnosed with adhesive capsulities |
|
| ExclusionCriteria |
| Details |
musculoskeletal and neurological condition
other shoulder related pathology that can mimic adhesive capsulities |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS
Universal goniometer
Shoulder pain and disability index |
primary outcome measures will be assessed on 1st day prior to the exercise session and on 6th day post exercise session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/10/2023 |
| 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
|
TITLE OF THE STUDY:- Effect of scapula stabilisation exercises in patients with adhesive capsulitis INTRODUCTION:- Frozen shoulder is a condition characterized by active and passive shoulder motions restriction; giving rise to insidious stiffness, severe pain even with no typical findings in history or radiographic evaluation. This condition has high prevalence rate, more common in women especially between 4th to 6th decade, proven to rise moderate to high level of disability. Stretching has been proposed as an effective approach for the management of GIRD, restoring shoulder ROM, and reducing the incidence of shoulder injury and muscle soreness. Novel Stretch - A shoulder stretch performed in bridging position. Bridging was incorporated to maximize the contact area to upper back and scapula, thus more pressure is placed on the scapula. That way, scapular movements get limited allowing for a accurate stretching of the external rotators. AIM:- To assess the effects of scapula stabilisation exercises in patients with frozen shoulder. OBJECTIVE:- 1]To assess the effects of Conventional exercise in patients with frozen shoulder. 2]To assess the effects of Interventional exercise(novel exercise group) in patients with frozen shoulder. 3]To compare the effects of Conventional exercise and Interventional exercise(novel exercise group) in patients with frozen shoulder. Inclusion Criteria :- Patients diagnosed with Frozen shoulder. Exclusion Criteria:- 1]Any muscular or neurological condition. 2]Other shoulder related pathology that can mimic frozen shoulder. Outcome Measures - 1]VAS 2]Shoulder Pain And Disability Index 3] Universal Goniometer |