Comparison of the Effectiveness of Two Corticosteroid Dosages in Ultrasound-guided Capsular Hydrodilatation in Patients with Adhesive Capsulitis: A Randomized, Triple-blind, Non-inferiority Study
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Abstract
BACKGROUND: Hydrodilatation is one of the common treatments for adhesive capsulitis (AC) and aims to achieve physical distension of the shoulder joint capsule by injecting a considerable amount of fluid that contains normal saline, corticosteroids, and local anesthetics into the joint. The dosage of triamcinolone acetonide (TA) commonly used in hydrodilatation fluid is 20-40 mg. Intra-articular corticosteroids have many potential complications.
OBJECTIVES: To compare the effectiveness of two corticosteroid dosages (10 mg VS 40 mg TA) in ultrasound-guided capsular hydrodilatation in patients with AC
METHODS: A randomized, triple-blind, non-inferiority study. Forty-two participants who had been diagnosed with AC were randomly divided into 2 groups. Both groups received ultrasound-guided hydrodilatation. Hydrodilatation fluid in the 10 mg TA group contained 1 mL of 10 mg TA, 5 mL of 1% lidocaine, and 14 mL of normal saline solution, while in the 40 mg TA group contained 1 mL of 40 mg TA, 5 mL of 1% lidocaine, and 14 mL of normal saline solution. Outcome measures include the Shoulder Pain and Disability Index (SPADI) as primary outcome, passive range of motion, and visual analogue scale at 4 weeks.
RESULTS: The mean SPADI at 4 weeks were 27.5±12 in 10 mg TA group and 24.5±13 in 40 mg TA group. The upper bound of the 95% CI of 10 mg group (33.0) lay below the lower bound of the 95% CI of 40 mg TA group (18.6) plus non-inferiority margin of 15 (33.6). There was also no significant difference between the two groups at 4 weeks for all secondary outcome measurements except passive external rotation of the shoulder.
CONCLUSIONS: Using 10 mg of TA in hydrodilatation fluid was similar to using 40 mg of TA in terms of function improvement in patients with stage 2 and 3 of AC. For patients with AC, hydrodilatation with a low dose of corticosteroids may be the optimal treatment option.
Thaiclinicaltrials.org number, TCTR20201125003
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