Health Condition 1: M750- Adhesive capsulitis of shoulder
Conditions
Interventions
Intervention1: Triamcinolone Hexacetonide Injection (20 mg/ml): Dose: 20mg/ml per injection
Frequency: Single dose for the trial
Mode: Intra-Articular
Control Intervention1: NIL: NIL
Sponsors
Abbott India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total SPADI score from baseline to Week 4Timepoint: Change in the total SPADI score from baseline to Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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.Timepoint: 1, 4, 8 and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Ashwini Kumar
Abbott India Limited
Outcome results
None listed