| CTRI Number |
CTRI/2024/06/069688 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Study to evaluate safety and effectiveness of injection for patients seeking treatment for Frozen Shoulder |
|
Scientific Title of Study
|
A Prospective, Multicenter, Open-label, Post-Marketing Observational Study to Evaluate the Effectiveness and Safety of Triamcinolone Hexacetonide Intra-Articular Injection in Adhesive Capsulitis of the Shoulder (Frozen Shoulder) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TRIA-524-0484 Version 1.0 dated 24-May-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivani Acharya |
| Designation |
Associate Director Clinical Development & Operation |
| Affiliation |
Abbott India Limited |
| Address |
Abbott India Limited,
Godrej BKC, Plot No C-68,
Bandra Kurla Complex,
Bandra East,
Mumbai-400051, Maharashtra, India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
8657552543 |
| Fax |
|
| Email |
shivani.acharya@abbott.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Acharya |
| Designation |
Associate Director Clinical Development & Operation |
| Affiliation |
Abbott India Limited |
| Address |
Abbott India Limited,
Godrej BKC, Plot No C-68,
Bandra Kurla Complex,
Bandra East,
Mumbai-400051, Maharashtra, India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
8657552543 |
| Fax |
|
| Email |
shivani.acharya@abbott.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Kumar |
| Designation |
Chief Executive Officer |
| Affiliation |
CliniExperts Research Services |
| Address |
Unit no. 325, Plot no. 05, City Centre Mall, Dwarka Sector 12, Dwarka, New Delhi, 110075
West
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
|
Source of Monetary or Material Support
|
| Abbott India Limited, Godrej BKC, Plot No C-68,
Bandra Kurla Complex,
Bandra East,
Mumbai-400051, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Abbott India Limited |
| Address |
Godrej BKC, Plot No C-68,
Bandra Kurla Complex,
Bandra East,
Mumbai-400051, Maharashtra, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashwani Bilandi |
ManglamPlus Medicity Hospital |
Room no 203, Research Department, ManglamPlus Medicity Hospital, Sector 5, Shipra Path, Mansarovar Jaipur Jaipur, Rajasthan - 302020 India
Jaipur
RAJASTHAN |
9899278007
ashwani.bilandi@gmail.com |
| Dr Marju Adithya Nayak Sreenivas |
Medstar Speciality Hospital |
641/17/1/3, Medstar Speciality Hospital, Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA |
9035302352
dradithyamedstar@gmail.com |
| DrAnil Kumar Sharma |
Pushpanjali Hospital and Research Centre PVT LTD |
Pushpanjali Palace, Delhi Gate Rd, Agra, Uttar Pradesh 282002
Agra
UTTAR PRADESH |
8357077174
shroti.anil@gmail.com |
| Dr Tadikonda Bhavani Prasad |
Visakha Institute of Medical Sciences |
18-23/1, Mudasarlova Rd, Pedda Gadhili, Hanumanthavaka, Visakhapatnam, Andhra Pradesh 530040
Visakhapatnam
ANDHRA PRADESH |
9849125986
drbhavaniprasadtresearch@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Mangalam Medicity Hospital Institutional Ethics Committee |
Approved |
| Medstar Speciality Hospital Ethics Committee Medstar Speciality Hospital N0 614, 17/1/3, Kodigehalli Main Road sahakarnagar Post Bangalore Bengaluru (Bangalore) Urban Karnataka - 560092 India |
Approved |
| Pushpanjali Hospital Ethics Committee Pushpanjali Hospital and Research Centre Pvt. Ltd. Pushpanjali Palace Near Delhi Gate Agra Agra Uttar Pradesh - 282002 India |
Approved |
| Visakha Institute of Medical Sciences (VIMS),S.NO 97/2,Hanumanthawaka, Chinagadilli Village, Visakhapatnam (India) - 530040 India |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Triamcinolone Hexacetonide Injection (20 mg/ml) |
Dose: 20mg/ml per injection
Frequency: Single dose for the trial
Mode: Intra-Articular
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects aged ≥18 years.
2. Have been symptomatic for adhesive capsulitis of the shoulder for less than 1 year.
3. Should have a diagnosis of adhesive capsulitis as per the Investigator’s discretion
4. Patients with a total score of ≥30 on the SPADI.
5. Patients are willing and able to comply with the study procedures and sign the patient authorization form.
6. Patients who have been prescribed a single USG guided intra-articular injection of triamcinolone hexacetonide 20 or 40 mg for the treatment of frozen shoulder, as part of routine clinical practice. |
|
| ExclusionCriteria |
| Details |
1. Adhesive capsulitis is secondary to another cause, including inflammatory, degenerative, metabolic, or infectious arthritis, cerebrovascular accident, dislocation or fracture
2. Significant (requiring surgical correction) deformity of the target joint.
3. Concomitant inflammatory or any other disease/condition which may affect joints (e.g metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis, etc.).
4. History of sepsis in the target joint or any clinical concern for acute or sub-acute infectious process in the target joint e.g. active tuberculosis, herpes simplex keratitis, systemic mycoses and parasitoses (strongyloid infections).
5. Clinically apparent tense effusion at the target joint.
6. Skin disease or infection in the area of the injection site.
7. Arthrocentesis in the past 3 months.
8. Allergic to the study drug or any of the other ingredients.
9. Participation in any other clinical study in the past 30 days.
10. Patients who had received intra-articular and/or periarticular systemic steroids in the previous 3 months.
11. Any contraindication to intra-articular and/or periarticular injection.
12. Females with child-bearing potential who are pregnant or planning to become pregnant or are not ready to use contraceptive measures or are lactating.
13. Patients with any other disease/comorbidities which may be exacerbated with THA administration as per Investigator discretion.
14. Patient with known blood coagulation disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the total SPADI score from baseline to Week 4 |
Change in the total SPADI score from baseline to Week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Change in the total SPADI score from baseline to Weeks 1, 8, and 12.
• Change in SPADI subscale of pain score from baseline to Weeks 1, 4, 8, and 12.
• Change in SPADI subscale of disability score from baseline to Weeks 1, 4, 8, and 12. |
1, 4, 8 and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
09/07/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This is an observational, non-interventional study that will be conducted in 3 to 4 centers in India. Patients seeking treatment for frozen shoulder and prescribed USG guided intra-articular injection of triamcinolone hexacetonide at the respective study sites will be consecutively enrolled in the study after assessment of eligibility criteria. This multicenter study will enroll 60 patients, with Adhesive Capsulitis of the Shoulder (Frozen Shoulder). The study will consist of a total of 5 visits. At the first visit, the subject will receive the study medication followed by 4 follow-up visits. The selection of patients for the study will be totally at the discretion of the investigator, and as per the study protocol. All the patients diagnosed with symptoms of Adhesive Capsulitis of the Shoulder (Frozen Shoulder), meeting inclusion and exclusion criteria, and ready to give written informed consent for study participation, are eligible for participation in this study. The study is planned to be conducted for approximately Six (6)- months. |