Clinical trial NCT04347733: Hyaluronidase in Intra-articular Steroid Injection Treating the Adhesive Capsulitis for Shoulder
Official title: Additive Effects of Hyaluronidase in Intra-articular Steroid Injection Treating the Initial Stage of Adhesive Capsulitis for Shoulder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adhesive Capsulitis of Shoulder
Keywords: Intra-articular injections
Steroids
Hyaluronidase
Ultrasonography
Lead sponsor: Veterans Health Service Medical Center, Seoul, Korea
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of visual analogue scale (VAS)
timeFrame: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection
Secondary outcomes:
measure: Change of shoulder disability questionnaire (SDQ)
timeFrame: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection
measure: Change of degree for the abduction motion of shoulder
timeFrame: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection
measure: Change of degree for the flexion motion of shoulder
timeFrame: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection
measure: Change of area for the intra-sheath fluid
timeFrame: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Veterans Health Service Medical Center
Study officials:
affiliation: Veterans Health Service Medical Center, Seoul, Korea
name: Wonjae Lee, MD, Ph D
role: STUDY_DIRECTOR
References:
citation: Fields BKK, Skalski MR, Patel DB, White EA, Tomasian A, Gross JS, Matcuk GR Jr. Adhesive capsulitis: review of imaging findings, pathophysiology, clinical presentation, and treatment options. Skeletal Radiol. 2019 Aug;48(8):1171-1184. doi: 10.1007/s00256-018-3139-6. Epub 2019 Jan 3.
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citation: Buhren BA, Schrumpf H, Hoff NP, Bolke E, Hilton S, Gerber PA. Hyaluronidase: from clinical applications to molecular and cellular mechanisms. Eur J Med Res. 2016 Feb 13;21:5. doi: 10.1186/s40001-016-0201-5.
citation: Cho CH, Song KS, Kim BS, Kim DH, Lho YM. Biological Aspect of Pathophysiology for Frozen Shoulder. Biomed Res Int. 2018 May 24;2018:7274517. doi: 10.1155/2018/7274517. eCollection 2018.