| CTRI Number |
CTRI/2020/03/023688 [Registered on: 02/03/2020] Trial Registered Prospectively |
| Last Modified On: |
12/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Proportion Of Muscle Imbalances Of the neck and shoulder In Subjects With Frozen Shoulder (Adhesive Capsulitis). |
|
Scientific Title of Study
|
Proportion Of Upper Crossed Syndrome In Subjects With Adhesive Capsulitis. |
| Trial Acronym |
POUCSISWAC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Jaideep |
| Designation |
Post Graduate |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Department Of Physiotherapy
Kasturba Medical College
Center for Basic Sciences
Bejai
Mangalore.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9867357633 |
| Fax |
|
| Email |
aaisha3jaideep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Eapen |
| Designation |
HOD, Dept. Of Physiotherapy. |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Department of Physiotherapy
Kasturba Medical College
Center for Basic Sciences
Bejai
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9986024551 |
| Fax |
|
| Email |
charu.eapen@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charu Eapen |
| Designation |
HOD, Dept. Of Physiotherapy. |
| Affiliation |
Manipal Academy Of Higher Education |
| Address |
Department of Physiotherapy
Kasturba Medical College
Center for Basic Sciences
Bejai
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9986024551 |
| Fax |
|
| Email |
charu.eapen@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy Of Higher Education |
|
|
Primary Sponsor
|
| Name |
Manipal Academy Of Higher Education |
| Address |
Kasturba Medical College, Mangalore-575001. India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Aishwarya Jaideep |
Kasturba Medical College Hospital |
Room no.- 3
2nd floor
Department of Physiotherapy
Kasturba Medical College Hospital
Attavar;
and 5th floor Department of Physiotherapy Kasturba Medical College Hospital Ambedkar circle. Mangalore-575001
Dakshina Kannada
KARNATAKA |
9867357633
aaisha3jaideep@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M258||Other specified joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with clinically diagnosed adhesive capsulitis by a primary care physician or orthopedic
2.Subjects with either idiopathic or secondary adhesive capsulitis.
3.Subjects with <50% ROM restriction in more than two planes as compared to the unaffected limb.
4.Pain during sleep, difficulty with grooming, dressing activities, reaching activities behind the back and overhead.
|
|
| ExclusionCriteria |
| Details |
1.Acute post surgical cases involving shoulder conditions.
2.Rheumatologic or Neurological disorders affecting the shoulder.
3.Associated fracture or recurrent subluxations.
4.Scoliosis(structural/functional)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Julls test, shoulder abduction test, cervical flexion test.
Muscle lengths (levator scapular and pectoralis minor), muscle strength (upper and middle trapezius and serratus anterior), Cranio-vertebral angle measure. |
day of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shoulder Pain And Disability Index (SPADI) |
Day of recruitment |
|
|
Target Sample Size
|
Total Sample Size="73"
Sample Size from India="73"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2020 |
| Date of Study Completion (India) |
31/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
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
|
The standard protocol for assessment in cases involving shoulder stiffness and adhesive capsulitis do not involve ruling out possible muscle length insufficiencies and faulty posture patterns as seen in upper crossed syndrome and hence all components might not be taken into consideration when planning treatment strategies.
If the proportion of upper crossed muscle imbalance is found to be more in patients with AC, it can be used improvise the diagnostic and therapeutic approach towards treating adhesive capsulitis conditions. |