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

Tadikonda Bhawani Prasad; Anil Kumar Sharma; Manju Adithya Nayak; Ashwani Bilandi; Swapnil Deshpande; Milind Bhole

doi:10.18203/issn.2455-4510.IntJResOrthop20262809

Authors

Tadikonda Bhawani Prasad Visakha Institute of Medical Sciences, Hanumanthavaka, Visakhapatnam, Andhra Pradesh, India
Anil Kumar Sharma Pushpanjali Hospital and Research Centre PVT LTD, Agra, Uttar Pradesh, India
Manju Adithya Nayak Medstar Speciality Hospital, Sahakarnagar, Bengaluru, Karnataka, India
Ashwani Bilandi ManglamPlus Medicity Hospital, Jaipur, Rajasthan, India
Swapnil Deshpande Department of Medical Affairs, Abbott India Limited, BKC, Bandra (E), Mumbai, Maharashtra, India
Milind Bhole Department of Medical Affairs, Abbott India Limited, BKC, Bandra (E), Mumbai, Maharashtra, India

DOI:

https://doi.org/10.18203/issn.2455-4510.IntJResOrthop20262809

Keywords:

Adhesive capsulitis, Frozen shoulder, Triamcinolone hexacetonide, Intra-articular injection, Shoulder pain and disability index, Real-world observational study

Abstract

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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References

Grey RG. The natural history of "idiopathic" frozen shoulder. J Bone Joint Surg Am. 1978;60(4):564. DOI: https://doi.org/10.2106/00004623-197860040-00029

van der Windt DA, Koes BW, de Jong BA, Bouter LM. Shoulder disorders in general practice: incidence, patient characteristics, and management. Ann Rheum Dis. 1995;54(12):959-64. DOI: https://doi.org/10.1136/ard.54.12.959

Le HV, Lee SJ, Nazarian A, Rodriguez EK. Adhesive capsulitis of the shoulder: review of pathophysiology and current clinical treatments. Shoulder Elbow. 2017;9(2):75-84. DOI: https://doi.org/10.1177/1758573216676786

Hannafin JA, Chiaia TA. Adhesive capsulitis. A treatment approach. Clin Orthop Relat Res. 2000;(372):95-109. DOI: https://doi.org/10.1097/00003086-200003000-00012

Zreik NH, Malik RA, Charalambous CP. Adhesive capsulitis of the shoulder and diabetes: a meta-analysis of prevalence. Muscles Ligaments Tendons J. 2016;6(1):26-34. DOI: https://doi.org/10.32098/mltj.01.2016.04

Park HB, Gwark JY, Jung J. What Serum Lipid Abnormalities Are Associated with Adhesive Capsulitis Accompanied by Diabetes? Clin Orthop Relat Res. 2018;476(11):2231-7. DOI: https://doi.org/10.1097/CORR.0000000000000443

Sung CM, Jung TS, Park HB. Are serum lipids involved in primary frozen shoulder? A case-control study. J Bone Joint Surg Am. 2014;96(21):1828-33. DOI: https://doi.org/10.2106/JBJS.M.00936

Park HB, Gwark JY, Jung J, Jeong ST. Involvement of inflammatory lipoproteinemia with idiopathic adhesive capsulitis accompanying subclinical hypothyroidism. J Shoulder Elbow Surg. 2022;31(10):2121-7. DOI: https://doi.org/10.1016/j.jse.2022.03.003

Bunker T. (II) frozen shoulder. Orthop Trauma. 2011;25:11-8. DOI: https://doi.org/10.1016/j.mporth.2011.01.007

Binder AI, Bulgen DY, Hazleman BL, Roberts S. Frozen shoulder: a long-term prospective study. Ann Rheum Dis. 1984;43(3):361-4. DOI: https://doi.org/10.1136/ard.43.3.361

Cho C-H, Koo TW, Cho N-S. Demographic and clinical characteristics of primary frozen shoulder in a Korean population. Clin Shoulder Elbow. 2015;18:133-7. DOI: https://doi.org/10.5397/cise.2015.18.3.133

Neviaser RJ, Neviaser TJ. The frozen shoulder: diagnosis and management. Clin Orthop Relat Res. 1987;(223):59-64. DOI: https://doi.org/10.1097/00003086-198710000-00008

Reeves B. The natural history of the frozen shoulder syndrome. Scand J Rheumatol. 1975;4(4):193-6. DOI: https://doi.org/10.3109/03009747509165255

Page MJ, Green S, Kramer S, Johnston RV, McBain B, Buchbinder R. Electrotherapy modalities for adhesive capsulitis (frozen shoulder). Cochrane Database Syst Rev. 2014;2014:CD011324. DOI: https://doi.org/10.1002/14651858.CD011324

Kim JY, Gahlot N, Park HB. Frozen shoulder: a narrative review of current treatment concepts and the underlying scientific evidence. Clin Shoulder Elb. 2025;28(4):529-46. DOI: https://doi.org/10.5397/cise.2025.00220

Allen RJ. Physical agents used in the management of chronic pain by physical therapists. Phys Med Rehabil Clin N Am. 2006;17(2):315-45. DOI: https://doi.org/10.1016/j.pmr.2005.12.007

Watson T. Ultrasound in contemporary physiotherapy practice. Ultrasonics. 2008;48(4):321-9. DOI: https://doi.org/10.1016/j.ultras.2008.02.004

O'Brien WD Jr. Ultrasound-biophysics mechanisms. Prog Biophys Mol Biol. 2007;93(1-3):212-55. DOI: https://doi.org/10.1016/j.pbiomolbio.2006.07.010

Prestgaard T, Wormgoor ME, Haugen S, Harstad H, Mowinckel P, Brox JI. Ultrasound-guided intra-articular and rotator interval corticosteroid injections in adhesive capsulitis of the shoulder: a double-blind, sham-controlled randomized study. Pain. 2015;156(9):1683-91. DOI: https://doi.org/10.1097/j.pain.0000000000000209

Sun Y, Liu S, Chen S, Chen J. The effect of corticosteroid injection into rotator interval for early frozen shoulder: a randomized controlled trial. Am J Sports Med. 2018;46(3):663-70. DOI: https://doi.org/10.1177/0363546517744171

Singh H, Rathore LP, Salimath S, Makhija M, Phadke V. Ultrasonography-guided corticosteroid injection in the coracohumeral ligament in patients with adhesive capsulitis of the shoulder: a double-blinded, sham-controlled randomized study. J Shoulder Elbow Surg. 2024;33(12):2553-62. DOI: https://doi.org/10.1016/j.jse.2024.06.015

Mao B, Peng R, Zhang Z, Zhang K, Li J, Fu W. The effect of intra-articular injection of hyaluronic acid in frozen shoulder: a systematic review and meta-analysis of randomized controlled trials. J Orthop Surg Res. 2022;17(1):128. DOI: https://doi.org/10.1186/s13018-022-03017-4

Li S, Zhang W, Lin Y. Application of Intra-articular Corticosteroid Injection in Juvenile Idiopathic Arthritis. Front Pediatr. 2022;10:822009. DOI: https://doi.org/10.3389/fped.2022.822009

Parra DA. Technical tips to perform safe and effective ultrasound guided steroid joint injections in children. Pediatr Rheumatol Online J. 2015;13:2. DOI: https://doi.org/10.1186/1546-0096-13-2

Bruyn GA, Schmidt WA. How to perform ultrasound-guided injections. Best Pract Res Clin Rheumatol. 2009;23(2):269-79. DOI: https://doi.org/10.1016/j.berh.2008.11.001

Derendorf H, Hochhaus G, Rohatagi S, Möllmann H, Barth J, Sourgens H, et al. Pharmacokinetics of triamcinolone acetonide after intravenous, oral, and inhaled administration. J Clin Pharmacol. 1995;35:302-5. DOI: https://doi.org/10.1002/j.1552-4604.1995.tb04064.x

Gallizzi R, Dipasquale RF, Mendicino A, Ferrillo M, Longo UG, Concolino D, et al. Effectiveness of steroid intra-articular injections on functioning in children and adolescents affected by juvenile idiopathic arthritis: a systematic review. Eur J Pediatr. 2025;184:708. DOI: https://doi.org/10.1007/s00431-025-06486-x

Carette S, Moffet H, Tardif J, Bessette L, Morin F, Frémont P, et al. Intraarticular corticosteroids, supervised physiotherapy, or a combination of the two in the treatment of adhesive capsulitis of the shoulder: a placebo-controlled trial. Arthritis Rheum. 2003;48:829-38. DOI: https://doi.org/10.1002/art.10954

Wang W, Shi M, Zhou C, Shi Z, Cai X, Lin T, Yan S. Effectiveness of corticosteroid injections in adhesive capsulitis of shoulder: A meta-analysis. Medicine (Baltimore). 2017;96(28):e7529. DOI: https://doi.org/10.1097/MD.0000000000007529

Sensoz E, Sevım OF, Cakmak H, Edız SS, Ecevız E, Ergun S. Similar short-term outcomes of ultrasound guided posterior intra-articular and anterior extra-articular corticosteroid injection in the treatment of primary frozen shoulder. A randomized controlled, single-blind study. Acta Orthop Traumatol Turc. 2024;58(4):223-8. DOI: https://doi.org/10.5152/j.aott.2024.23171

Ranalletta M, Rossi LA, Bongiovanni SL, Tanoira I, Elizondo CM, Maignon GD. Corticosteroid Injections Accelerate Pain Relief and Recovery of Function Compared With Oral NSAIDs in Patients With Adhesive Capsulitis: A Randomized Controlled Trial. Am J Sports Med. 2016;44(2):474-81. DOI: https://doi.org/10.1177/0363546515616238

Kumar S, Kumar V, Balasubramanian S, Kasirajan S. A Prospective Randomized Study Comparing the Efficacy of Electrotherapy to Ultrasound-Guided Intra-Articular Steroid Injections for Frozen Shoulder. J Orthopaed Case Rep. 2025;15(18):332-9. DOI: https://doi.org/10.13107/jocr.2025.v15.i08.5986

Ryans I, Montgomery A, Galway R, Kernohan WG, McKane R. A randomized controlled trial of intra-articular triamcinolone and/or physiotherapy in shoulder capsulitis. Rheumatology (Oxford). 2005;44(4):529-35. DOI: https://doi.org/10.1093/rheumatology/keh535