| CTRI Number |
CTRI/2025/09/094553 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Development and Testing of New Clinical Shoulder Tests for Early-Stage Frozen Shoulder Using MRI Findings |
|
Scientific Title of Study
|
Development and Validation of Clinical Diagnostic Tests for Stage I and II Idiopathic Frozen Shoulder Using MRI Features of the Rotator Interval |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshitha K R |
| Designation |
Assistant professor |
| Affiliation |
srinivas university |
| Address |
srinivas college institute of physiotherapy
srinivas college institute of physiotherapy
Pandeshwar, Mangalore
karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
08748833315 |
| Fax |
|
| Email |
vnodakr19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijayakumar P |
| Designation |
Professor |
| Affiliation |
srinivas university |
| Address |
srinivas college institute of physiotherapy
srinivas college institute of physiotherapy
Pandeshwar, Mangalore
karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
08748833315 |
| Fax |
|
| Email |
vijayan.pswmy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akshitha K R |
| Designation |
Assistant professor |
| Affiliation |
srinivas university |
| Address |
srinivas college institute of physiotherapy
srinivas college institute of physiotherapy
Pandeshwar, Mangalore
karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
08748833315 |
| Fax |
|
| Email |
vnodakr19@gmail.com |
|
|
Source of Monetary or Material Support
|
| institutional support srinivas intitute of medical science and research mukka Mangalore, India 575001 |
|
|
Primary Sponsor
|
| Name |
Srinivas college and research centre |
| Address |
srinivas college institute of physiotherapy and srinivas college of medical science and research centre Mukka, Mangalore 575001 |
| 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 Akshitha K R |
Srinivas hospital |
The study will be conducted at the Department of Musculoskeletal Sciences, in collaboration with the Departments of Orthopaedics and Radiology, Srinivas University, which is providing the necessary infrastructural support
Dakshina Kannada
KARNATAKA |
08748833315
akshithakr.pt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srinivas University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
frozen shoulder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 35 to 70 years.
2. Clinical diagnosis of Stage I or Stage II idiopathic frozen shoulder.
3. Shoulder pain duration more than or equal to 1 month.
4. External rotation loss more than or equal to 25 degrees compared to the opposite side.
5. Willing to undergo MRI and provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1. History of post traumatic or post surgical shoulder stiffness.
2. Presence of full thickness rotator cuff tear.
3. Presence of moderate to severe glenohumeral osteoarthritis.
4. Systemic inflammatory diseases such as rheumatoid arthritis or lupus.
5. Contraindications to MRI such as pacemaker, metal implants, or claustrophobia.
6. Received steroid injection within the last three months.
7. Bilateral frozen shoulder.
8. High body mass index or high triceps skinfold thickness as per study cutoff.
9. Normal MRI findings despite clinical features of frozen shoulder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Validity and diagnostic accuracy of coroid pain test scale, DTPER, ERPT WITH MRI |
At baseline as it is one time study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Inter-rater & intra-rater reliability of the clinical tests (measured using kappa/ICC values).
Timepoint Within 1 week of initial testing.
Correlation of clinical test findings with MRI-based grading of rotator interval pathology.
|
Baseline.
|
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
30/09/2025 |
| 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="6"
Days="30" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [akshithakr.pt@gmail.com].
- For how long will this data be available start date provided 30-09-2025 and end date provided 06-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - none
|
|
Brief Summary
|
Idiopathic frozen shoulder (IFS) is a common musculoskeletal condition characterized by pain and restricted shoulder motion. Accurate diagnosis in the early stages remains difficult due to the absence of validated, anatomically grounded clinical tests. Existing bedside assessments such as the Coracoid Pain Test (CPT), Direct Tenderness Palpation of External Rotation (DTPER), and External Rotation Positional Test (ERPT) show promise but have not been validated against imaging.
Magnetic resonance imaging (MRI) is capable of detecting key rotator interval (RI) changes in IFS, including coracohumeral ligament thickening and anterior capsule fibrosis, but its cost and limited accessibility make it impractical for routine screening.
This cross-sectional diagnostic study aims to develop and validate the Coracoid Pain Test Scale (CPTS) and evaluate its reliability and diagnostic accuracy, along with DTPER and ERPT, using MRI findings of the rotator interval as the anatomical reference standard. Adult participants with Stage I and II IFS will be assessed, with inclusion and exclusion criteria applied to minimize confounding conditions. The primary outcome will be the diagnostic accuracy of CPTS compared with MRI. Findings are expected to provide clinicians with a standardized, reliable, and cost-effective tool for early diagnosis of frozen shoulder, reducing unnecessary imaging referrals and supporting timely, evidence-based management. |