| CTRI Number |
CTRI/2026/02/103057 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
14/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand the link between shoulder joint tissue thickness and shoulder pain examination test in patients with frozen shoulder |
|
Scientific Title of Study
|
Relationship between rotator interval capsule thickness & coracoid pain test in adhesive capsulitis patients - A feasibility study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samridhi Shukla |
| Designation |
Post graduate student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper Basement Department of Physiotherapy Manipal Hospital No 98 Rustam Bagh Old airport road Bangalore Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
7747932155 |
| Fax |
|
| Email |
samridhi.mhsblr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karvannan H |
| Designation |
Head & Associate Proffessor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper Basement Department of Physiotherapy Manipal Hospital No 98 Rustam Bagh Old airport road Bangalore Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karvannan H |
| Designation |
Head & Associate Proffessor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper Basement Department of Physiotherapy Manipal Hospital No 98 Rustam Bagh Old airport road Bangalore Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professionals, Manipal Academy of Higher Education, Manipal Hospital ,98, HAL, Old Airport Road , Karnataka,560017, India |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professionals, Manipal Academy of Higher Education, Manipal Hospital ,98, HAL, Old Airport Road , Karnataka,560017, 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 |
| Dr Karvannan H |
Manipal Hospital |
Upper Basement, Department of Physiotherapy , Manipal Hospital , No 98 , HAL, Old airport road, Bangalore , Karnataka
Bangalore
KARNATAKA |
9986565966
karvannan.h@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Of Manipal Hospitals, Bangalore |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed individuals based on established Codman’s criteria
and confirmed with ultrasound imaging (rotator interval)
Adults between age 30 - 70 years.
Adhesive capsulitis with unilateral involvement.
Patients at any stage of frozen shoulder.
The capacity and readiness to give informed permission and adhere to research
guidelines. |
|
| ExclusionCriteria |
| Details |
Patients with other Shoulder Pathologies like Rotator cuff tears, Calcific tendinitis,
Shoulder arthritis, etc.
Patients who have received intra-articular steroid injections or started intensive
therapy in the past weeks.
Patients with Systemic conditions Affecting Shoulder Mobility like Rheumatoid
arthritis, inflammatory arthropathies, Neurological disorders like stroke. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Coracoid pain test |
Immediate observation only at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rotator interval capsule thickness, External rotation range of motion |
Immediate observation only at baseline |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/03/2026 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The coracoid pain test and assessment of external rotation ROM are simple clinical tools, but their diagnostic value remains largely subjective. Establishing a correlation between RIC thickness, coracoid pain test, and external rotation Range of motion may provide a reliable, non-invasive diagnostic triad. This approach could help identify disease severity and stage, particularly in resource limited settings, and enhance diagnostic accuracy. It may also guide early, stage-specific physiotherapy intervention. |