NCT04347733

Hyaluronidase in Intra-articular Steroid Injection Treating the Adhesive Capsulitis for Shoulder

Additive Effects of Hyaluronidase in Intra-articular Steroid Injection Treating the Initial Stage of Adhesive Capsulitis for Shoulder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Veterans Health Service Medical Center, Seoul, Korea · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Adhesive capsulitis (AC) is painful and disabling condition that is associated with a gradual loss of shoulder motion. Intra-articular steroid injection is a common treatment in the initial painful stage of AC, and its use in combination with hyaluronidase may offer increased therapeutic efficacy owing to synergistic effects. We determined the therapeutic efficiency of the co-administration of hyaluronidase in early AC by evaluating symptomatic, anthropometric, and imaging changes.

Detailed description

We enrolled eligible patients with primary adhesive capsulitis in the initial stage.The subjects were randomly assigned into 3 groups to receive ultrasound-guided intra-articular injections with 20 mg (group A) and 40 mg triamcinolone acetonide (group B) and 20 mg acetonide combined with hyaluronidase (group C). The outcome measures included the visual analogue scale (VAS), the shoulder disability questionnaire (SDQ), abduction and external rotation range of motion, and intra-sheath fluid (ISF) before treatment and at 2, 4, 8, and 16 weeks after treatment.

Conditions

• Adhesive Capsulitis of Shoulder

Interventions

Type	Name	Description
DRUG	Triamcinolone Acetonide 40mg/mL	We aimed to examine the therapeutic efficacy of the combination of hyaluronidase and steroid injection for adhesive capsulitis and to determine whether such a combination therapy might enable the total amount of steroids to be reduced.
DRUG	Hyaluronidase Injection	We aimed to examine the therapeutic efficacy of the combination of hyaluronidase and steroid injection for adhesive capsulitis and to determine whether such a combination therapy might enable the total amount of steroids to be reduced.

Timeline

• Start date: 2017-05-02
• Primary completion: 2019-03-27
• Completion: 2019-07-16
• First posted: 2020-04-15
• Last updated: 2020-04-15

Locations

1 site across 1 country: South Korea