The effectiveness and safety of triamcinolone hexacetonide intra-articular injection in adhesive capsulitis: results from a prospective, multicentre, single-arm, open-label post-marketing observational study
DOI:
https://doi.org/10.18203/issn.2455-4510.IntJResOrthop20262809Keywords:
Adhesive capsulitis, Frozen shoulder, Triamcinolone hexacetonide, Intra-articular injection, Shoulder pain and disability index, Real-world observational studyAbstract
Background: Adhesive capsulitis is a painful shoulder disorder causing progressive stiffness and restricted mobility. Despite widespread use of intra-articular corticosteroids, real-world evidence on triamcinolone hexacetonide in India remains limited. This prospective study assessed the effectiveness and safety of a single ultrasound-guided intra-articular injection in routine practice.
Methods: This prospective, multicenter, single-arm post-marketing observational study was conducted at four sites in India. Adults with symptomatic adhesive capsulitis received a single ultrasound-guided intra-articular injection of triamcinolone hexacetonide (20-40 mg). Effectiveness was measured by changes in SPADI total and subscale scores over 12 weeks, while safety was assessed through adverse event monitoring.
Results: A total of 60 patients (37 males, 23 females) with a mean (SD) age of 46.60 (15.56) years were enrolled, and all completed the study. Compared to the mean (SD) baseline score of 74.14 (14.40), total SPADI score declined significantly (p<0.0001) by 11.15 (8.19) and by 28.70 (27.19) points at week 4 and 12, respectively, with clinically meaningful improvement observed from week 1 and sustained through week 12. Pain and disability subscales demonstrated parallel statistically significant reductions. Treatment was well tolerated; mild, transient adverse events (AEs) were reported in 8.3% of patients and were not treatment-related.
Conclusions: In routine clinical practice, a single intra-articular injection of triamcinolone hexacetonide performed with ultrasound guidance was effective in alleviating pain and improving functional outcomes in patients with adhesive capsulitis, while demonstrating a favorable safety profile. These findings support its use as a practical treatment option for frozen shoulder and provide preliminary real-world evidence to inform future prospective studies.
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