| CTRI Number |
CTRI/2024/01/061277 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
03/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prosepctive observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Association of metabolic abnormalities in primary frozen shoulder |
|
Scientific Title of Study
|
Association of Metabolic abnormalities in primary frozen shoulder |
| Trial Acronym |
PFS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Barath Viswanath |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical college |
| Address |
Ground floor OPD building Department of orthopaedics Smt. Sharada Madhav Pai Kasturba hospital Manipal, Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9962827910 |
| Fax |
|
| Email |
barathviswanath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Pandey |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical college |
| Address |
Ground floor OPD building Department of orthopaedics Smt. Sharada Madhav Pai Kasturba hospital Manipal, Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8971564313 |
| Fax |
|
| Email |
vivek.pandey@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Barath Viswanath |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical college |
| Address |
Ground floor OPD building Department of orthopaedics Smt. Sharada Madhav Pai Kasturba hospital Manipal, Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9962827910 |
| Fax |
|
| Email |
barathviswanath@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Kasturba Medical College, manipal, Udupi |
| 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 |
| Dr Barath Viswanath |
Kasturba Hospital |
Ground floor OPD building Smt. Sharada Madhav Pai , Kasturba Hospital, Manipal, Udupi
Udupi
KARNATAKA |
9962827910
barathviswanath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital institutional Ethics committee -2 |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients above 18 years of age
History of non traumatic shoulder stiffness for more than 6 weeks
No detectable shoulder pathology in radiograph |
|
| ExclusionCriteria |
| Details |
Evidence of rotator cuff tear on USG
History of arthritis or arthropathy
Other causes of secondary shoulder stiffness
History of ipsilateral shoulder trauma
Patients with hemoglobinopathies, chronic liver disease, renal failure and gross anemia
Patients with overlying skin infections over the shoulder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association lof metabolic abnormalities in primary frozen shoulder |
Investigation done within 30 days of diagnosis of frozen shoulder |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Analyse the incidence of frozen shoulder in diabetic patients |
30 days |
| To analyse the incidence of frozen shoulder in hypothyroid patients |
30 days |
| To analyse the incidence of frozen shoulder in patients with deranged fasting lipid profile |
30 days |
| To analyse the incidence of frozen shoulder in patients with increased High sensitivity C reactive protein |
30 days |
|
|
Target Sample Size
|
Total Sample Size="323"
Sample Size from India="323"
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)
|
13/01/2024 |
| 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="2" |
|
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
|
Patients will be recruited after CTRI approval. The Patients will e recruited based on inclusion and exclusion criteria. In case of suspicion of primary frozen shoulder after taking brief history and examination. exclusion criteria will be ruled out and the following investigations ( RBS glycosylated Haemoglobin, TSH, Fasting lipid profile and High sensitivity CRP will be sent after taking informed consent and explaining to the patient about the study. Based on the values a correlation will be made between metabolic abnormalities and primary frozen shoulder |