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

Veterans Health Service Medical Center, Seoul, Korea

Status and phase: Completed; Phase 3

Conditions: Adhesive Capsulitis of Shoulder

Treatments: Drug: Triamcinolone Acetonide 40mg/mL; Drug: Hyaluronidase Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04347733

2017-03-011-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Normal findings on simple x-rays of the shoulder but limitations in passive range of motion on physical examination
• Increased intra-sheath fluid (ISF) sufficient to encircle the long head of the biceps tendon within the upper portion of the bicipital groove of the humerus.

Exclusion criteria

• Ultrasonographic diagnosis of other concomitant fundamental abnormalities causing shoulder pain such as rotator cuff tear, bicipital tendon rupture, calcific tendinopathy, and subacromial-subdeltoid bursitis
• A history of shoulder injury
• A history of more than 1 year of conservative treatment for chronic shoulder pain
• Corticosteroid or hyaluronidase injections within the prior 6 months
• Hemiplegic shoulder
• Self-reported history consistent with scapula fracture or disarticulation
• Ipsilaterally cervical herniated intervertebral disc or brachial plexus injury
• Diabetes mellitus refractory to insulin therapy or glycated hemoglobin greater than 6.5
• Refusal to participate in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Group A

Experimental group

Description:

Intra-articular injection, 20 mg (0.5 mL) of triamcinolone acetonide mixed with 2 mL of 2% lidocaine and 7.5 mL of normal saline

Treatment:

Drug: Triamcinolone Acetonide 40mg/mL

Group B

Experimental group

Description:

40 mg (1 mL) of triamcinolone acetonide mixed with 2 mL of 2% lidocaine and 7.0 mL of normal saline

Treatment:

Drug: Triamcinolone Acetonide 40mg/mL

Group C

Active Comparator group

Description:

20 mg (0.5 mL) of triamcinolone acetonide and 1 mL of hyaluronidase mixed with 2 mL of 2% lidocaine and 6.5 mL of normal saline

Treatment:

Drug: Hyaluronidase Injection

Drug: Triamcinolone Acetonide 40mg/mL