Status:

COMPLETED

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

Lead Sponsor:

Veterans Health Service Medical Center, Seoul, Korea

Conditions:

Adhesive Capsulitis of Shoulder

Eligibility:

All Genders

Phase:

PHASE3

Brief 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 st...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 2 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 16 2019

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04347733

Start Date

May 2 2017

End Date

July 16 2019

Last Update

April 15 2020

Active Locations (1)

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Veterans Health Service Medical Center

Seoul, South Korea, 05368