| CTRI Number |
CTRI/2015/12/006444 [Registered on: 17/12/2015] Trial Registered Retrospectively |
| Last Modified On: |
12/12/2015 |
| 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
|
Effects of upper back muscles strengthening on pain and shoulder movements in patients with stiff shoulder. |
|
Scientific Title of Study
|
Effects of Scapular Stabilization Exercises on Scapular Dyskinesis, Shoulder Range of Motion, Pain and Functional Status in Subjects with Adhesive Capsulitis- A Randomized Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maitreyi K Kulkarni |
| Designation |
Student |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Physiotherapy Kasturba Medical College
Centre for Basic Sciences
Bejai Mangalore
Department of Physiotherapy Light house Hill road
Hampankatta
Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9483042537 |
| Fax |
|
| Email |
maitri13k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Eapen |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Physiotherapy Kasturba Medical College
Centre for Basic Sciences
Bejai Mangalore
Department of Physiotherapy Light house Hill road
Hampankatta
Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9986024551 |
| Fax |
|
| Email |
charu_mak@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maitreyi K Kulkarni |
| Designation |
Student |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Physiotherapy Kasturba Medical College
Centre for Basic Sciences
Bejai Mangalore
Department of Physiotherapy Light house Hill road
Hampankatta
Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
|
| Fax |
|
| Email |
maitri13k@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Department of Physiotherapy
Kasturba Medical College
Centre for Basic Sciences
Bejai Mangalore 575004 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Maitreyi K Kulkarni |
KMC Hospitals, Mangalore |
Dept of Physiotherapy, 2nd floor, KMC hospital, Ambedkar circle, Mangalore
Dept of physiotherapy, 2nd floor, KMC Hospital, Attavar, Mangalore
Dakshina Kannada
KARNATAKA |
9483042537
maitri13k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Istitutuional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Adhesive capsulitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Interferential therapy, Glenohumeral and Scapulothoracic Joint Mobilization, Capsular stretching, Rotator cuff Strengthening, Scapular Stabilization exercises, Home exercise program |
Group 1 will receive Interferential therapy, Glenohumeral and Scapulothoracic Joint Mobilization, Capsular stretching, Rotator cuff Strengthening,and Home exercise program.Group 2 will receive Interferential therapy, Glenohumeral and Scapulothoracic Joint Mobilization, Capsular stretching, Rotator cuff Strengthening,Home exercise program and Scapular Stabilization exercises. |
| Comparator Agent |
Scapular Stabilization Exercises |
Group 1 will receive Interferential therapy, Glenohumeral and Scapulothoracic Joint Mobilization, Capsular stretching, Rotator cuff Strengthening,and Home exercise program.Group 2 will receive Interferential therapy, Glenohumeral and Scapulothoracic Joint Mobilization, Capsular stretching, Rotator cuff Strengthening,Home exercise program and Scapular Stabilization exercises. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Patient reports a gradual onset and progressive worsening of pain and stiffness
-Presence of scapular dyskinesis
-Pain and stiffness limit activities of daily living like sleeping, grooming, dressing, and reaching activities
-ROM in external rotation, abduction, and flexion is less than 50% in comparison to the other shoulder.
|
|
| ExclusionCriteria |
| Details |
-Bilateral shoulder involvement
-Shoulder pain is reproduced with palpatory provocation of the relevant peripheral nerve entrapment site.
-Any local (inflammation or infection) or systemic diseases (Coronary artery disease or myocardial infarction)
-Hypermobility
-Other conditions involving shoulder: rheumatoid arthritis, osteoarthritis of shoulder, osteoporosis, malignancies of shoulder
-Pain or disorders of cervical spine, elbow, wrist or hand.
-Injection with corticosteroids in the affected shoulder in the preceding 4 weeks.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Lateral scapula slide test,
Scapular Assistance Test |
Pre treatment and Post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analog scale, Goniometry, Shoulder Pain and Disability Index |
Pre treatment and Post treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
27/08/2015 |
| 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) |
Open to Recruitment |
|
Publication Details
|
Trial yet to be started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients who are diagnosed by consultants as adhesive capsulitis will be approached. Written informed consent will be taken. Participants will be screened for inclusion and exclusion criteria. The patients will be assessed by a blinded observer. Patient will be then randomly assigned to receive any one of the two groups according to computer generated random table. Treatment will be given for 12 sessions over a period of two weeks. Outcome measures will be taken before and after the treatment course. Group 1 will receive: - Interferential therapy for 20 minutes - Glenohumeral and Scapulothoracic joint mobilization - Anterior and Posterior capsular stretching - Isometric and Dynamic Rotator cuff strengthening - Home exercise program Group 2 will receive: -Same as Group 1 -Scapular stabilization exercises. |