| CTRI Number |
CTRI/2025/02/081054 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of psychological factors and socioeconomic status on recovery in patients with rotator cuff injuries. |
|
Scientific Title of Study
|
Association Between Psychological factors, Socioeconomic Status and Functional Outcome in Subjects With Rotator Cuff Pathologies: Cross-sectional 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 |
Riddhi Godia |
| Designation |
Post Graduate student |
| Affiliation |
Kasturba Medical College, Mangalore. MAHE |
| Address |
Kasturba Medical College
Department of Physiotherapy
Centre of Basic life sciences
Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
7977168387 |
| Fax |
|
| Email |
riddhi.mchpmlr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Eapen |
| Designation |
MPT, Ph.D. , Professor |
| Affiliation |
Kasturba Medical College Mangalore MAHE |
| Address |
Kasturba Medical College
Department of Physiotherapy
Centre of Basic Life Sciences Bejai
Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9986024551 |
| Fax |
|
| Email |
charu.eapen@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Riddhi Godia |
| Designation |
Post Graduate Student |
| Affiliation |
Kasturba Medical College Mangalore MAHE |
| Address |
Kasturba Medical college
Department of Physiotherapy
Centre of Basic Life Sciences
Bejai
Maangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
7977168387 |
| Fax |
|
| Email |
riddhi.mchpmlr2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College
Mangalore |
|
|
Primary Sponsor
|
| Name |
Kasturba medical college |
| Address |
Department of Physiotherapy
Kasturba medical college
Mangalore 575004
Karnataka
India |
| 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 |
| Riddhi Godia |
Kasturba Medical College Hospital Attavar |
Department of Physiotherapy
2nd Floor
Kasturba Medical College Hospital Attavar
Mangalore
575001
Dakshina Kannada
KARNATAKA |
7977168387
riddhi.mchpmlr2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee, KMC, Mangalore. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M759||Shoulder lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who are diagnosed with rotator cuff pathologies by an orthopeadic surgeon.
2. Participants needed to experience a painful arc during an active movement pf flexion and/or abduction and pain with resisted external rotation for detecting rotator cuff pathologies.
3. Participants needed range of glenohumeral movement to be largely preserved.
|
|
| ExclusionCriteria |
| Details |
1. Participants with a history of humeral instability.
2. Reasons to suspect systemic pathology including inflammatory disorders, cervical spine involvement or non-specific neck/shoulder pain.
3. Neurological symptoms.
4. Bilateral shoulder pain. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| OSPRO-YF, Modified Kuppuswamy scale. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SPADI |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
02/03/2025 |
| 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="0"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
The study title is Association between psychological factors, socioeconomic status and functional outcomes in subjects with rotator cuff pathologies: a cross-sectional study. The study aims to identify the psychological factors and socioeconomic status and to analyze the affected psychological domains in different socioeconomic categories. Furthermore it aims to assess the association between these psychological factors, socioeconomic status and the functional outcome in subjects with rotator cuff pathologies. Participants aged 18 to 75 years fulfilling the inclusion criteria would be recruited . The psychological component would be assesed using the OSPRO-YF scale; socioeconomic status using the Modified Kuppuswamy scale and functional outcome using SPADI. Data will further be subjected to statistical analysis. |