| CTRI Number |
CTRI/2020/03/024276 [Registered on: 26/03/2020] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| 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
|
Effect of shoulder internal rotator muscles and fascia movement in shoulder stiffness |
Scientific Title of Study
Modification(s)
|
Effect of Myofascial Release of Shoulder Internal Rotators in patients with Idiopathic Frozen Shoulder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amita Aggarwal |
| Designation |
Assistant Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Department of Kinesiotherapy
1st cabin, 3rd floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amita Aggarwal |
| Designation |
Assistant Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Department of Kinesiotherapy
1st cabin, 3rd floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Rathi |
| Designation |
Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Department of Community Medicine and Rehabilitation
1st cabin, 4th floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9850418712 |
| Fax |
|
| Email |
manisha.rathi@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Amita Aggarwal(Self) MPT Assistant Professor Dr.D.Y.Patil College of Physiotherapy, Dr.
D.Y.Patil Vidyapeeth,Sant Tukaram Nagar Pimpri-18 Pune, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Amita Aggarwal |
| Address |
Flat no. 1004 A Wing, Kamalraj Haridwar Society,Dighi, Pune.411015 |
| 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 |
| Amita Aggarwal |
Dr. D.Y. Patil College of Physiotherapy OPD |
Department of Kinesiotherapy,Ist CABIN,3rd floor,Dr. D.Y. Patil College of Physiotherapy,Sant Tukaram Nagar,Plot No. BGP/190,Pimpri-Chinchwad, Maharashtra 411018,Pune,India.
Pune
MAHARASHTRA |
7986972513
amita15pgi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D.Y. Patil Vidyapeeth, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional treatment |
Treatment will be given 5 days a week for 2 weeks.Total duration 30-40 minutes per session |
| Intervention |
Myofascial release |
Treatment will be given 5 days a week for 2 weeks.Total duration 30-40 minutes per session |
|
Inclusion Criteria
Modification(s)
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Unilateral Idiopathic or secondary adhesive capsulitis patients in stage 1 and 2
2 Tightness in any shoulder internal rotator as evidenced by reduced external rotation range in particular position
3 At least 90 degrees of elevation on affected shoulder
|
|
| ExclusionCriteria |
| Details |
1 Patients with associated neurological conditions such as stroke, Parkinsonism, upper or lower motor neuron disease.
2 Any history of upper extremity fracture, clavicle fracture in last 3 months.
3 Structural Scoliosis
4 Cervical spondylitis with radiating pain in arm and forearm
5 CABG or any associated cardiac disorder
6 Uncontrolled diabetes in last 3 months |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NPRS,Pressure pain threshold, SPADI, Shoulder range of motion,Scapular position,EMG |
On first session and after 10th session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
Target Sample Size
Modification(s)
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Title - Effect of myofascial release of shoulder internal rotators
in patients with idiopathic frozen shoulder
Need of the study- Shoulder
pain with limited ranges in idiopathic frozen shoulder are not only related
to capsular and ligamentous tightness but also fascial restrictions, muscle
tightness and trigger points within the muscles. This can happen out of
guarding or body response to prevent pain in Activity of daily living. Also
Scapular dyskinesia, one of the important manifestation in adhesive capsulitis
and its association with muscle imbalance makes it important to address muscle
role with the pathology. As capsular pattern has major component that begins
with external rotation limitation maximally followed by abduction and then
internal rotation, this study is undertaken to see if there is any effect of
shoulder internal rotators myofascial release on pain, range, disability,
scapula position along with all strength changes in idiopathic frozen shoulder
patients.
Objectives
1. To find the effect of
conventional rehabilitation on shoulder pain,disability,range,scapula position
and strength in idiopathic frozen shoulder.
2. To find the effect of
shoulder internal rotators myofascial release with conventional rehabilitation
on pain,disability,range, scapula position and
strength in idiopathic frozen shoulder .
3. To compare the effect of
conventional rehabilitation versus conventional rehabilitation with shoulder
internal rotators myofascial release on pain,disability,range, scapula
position and strength in idiopathic frozen shoulder .
Methodology-Based on
inclusion and exclusion criteria 62 subjects will be divided into two
groups.
Group A (Control) was
given conventional treatment
Group B (Experimental) was
given myofascial release to shoulder internal rotators with conventional
treatment
The treatment will be given
for 2 weeks,5 days a week.
Patients will be assessed
for pain, disability, range, scapula position and strength as outcome
measures at baseline and after 10 sessions.
Samples completed
Data analysis completed.
|