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

NCT04347733 | Completed Phase 3

• 1 other identifier: 2017-03-011-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis of Shoulder

Keywords

Intra-articular injections; Steroids; Hyaluronidase; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Change of visual analogue scale (VAS)

  Evaluation for the change of VAS that means average degree of shoulder pain for 24 hours before the evaluation (from 0 to 10 points)

  Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection

Secondary Outcomes (4)

• Change of shoulder disability questionnaire (SDQ)

  Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection

• Change of degree for the abduction motion of shoulder

  Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection

• Change of degree for the flexion motion of shoulder

  Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection

• Change of area for the intra-sheath fluid

  Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection

Study Arms (3)

Group A

EXPERIMENTAL

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

Drug: Triamcinolone Acetonide 40mg/mL

Group B

EXPERIMENTAL

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

Drug: Triamcinolone Acetonide 40mg/mL

Group C

ACTIVE COMPARATOR

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

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

Interventions

Triamcinolone Acetonide 40mg/mL DRUG

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.

Group A; Group B; Group C

Hyaluronidase Injection DRUG

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.

Also known as: Hirax Inj® BMI KOREA Pharmaceutical, South Korea

Group C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Veterans Health Service Medical Center, Seoul, Korea: lead

Study Sites (1)

Veterans Health Service Medical Center

Seoul, 05368, South Korea

Location

Related Publications (6)

• 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.

  PMID: 30607455 BACKGROUND

• Ahn JH, Lee DH, Kang H, Lee MY, Kang DR, Yoon SH. Early Intra-articular Corticosteroid Injection Improves Pain and Function in Adhesive Capsulitis of the Shoulder: 1-Year Retrospective Longitudinal Study. PM R. 2018 Jan;10(1):19-27. doi: 10.1016/j.pmrj.2017.06.004. Epub 2017 Jun 12.

  PMID: 28619380 BACKGROUND

• Tandon A, Dewan S, Bhatt S, Jain AK, Kumari R. Sonography in diagnosis of adhesive capsulitis of the shoulder: a case-control study. J Ultrasound. 2017 Aug 21;20(3):227-236. doi: 10.1007/s40477-017-0262-5. eCollection 2017 Sep.

  PMID: 28900523 BACKGROUND

• Byun SD, Park DH, Hong YH, Lee ZI. The additive effects of hyaluronidase in subacromial bursa injections administered to patients with peri-articular shoulder disorder. Ann Rehabil Med. 2012 Feb;36(1):105-11. doi: 10.5535/arm.2012.36.1.105. Epub 2012 Feb 29.

  PMID: 22506242 BACKGROUND

• 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.

  PMID: 26873038 RESULT

• 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.

  PMID: 29992159 RESULT

MeSH Terms

Conditions

Bursitis

Interventions

Triamcinolone Acetonide; Hyaluronoglucosaminidase

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases

Study Officials

• Wonjae Lee, MD, Ph D

  Veterans Health Service Medical Center, Seoul, Korea

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director for the department of physical medicine and rehabilitation

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 15, 2020
• Study Start: May 2, 2017
• Primary Completion: March 27, 2019
• Study Completion: July 16, 2019
• Last Updated: April 15, 2020

Record last verified: 2020-04

Locations

KR (1)