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

April 13, 2020 updated by: Wonjae Lee, MD PhD, Veterans Health Service Medical Center, Seoul, Korea

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05368
        • Veterans Health Service Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
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
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.
Experimental: Group B
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
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.
Active Comparator: Group C
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
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.
Other Names:
  • Hirax Inj® BMI KOREA Pharmaceutical, South Korea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of visual analogue scale (VAS)
Time Frame: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of shoulder disability questionnaire (SDQ)
Time Frame: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection
Evaluation for the change of SDQ that means the self-reported functional status in patients with shoulder disorders, comprised of 16 questions, reflecting the pain during various movements related with activities of daily living, with scores ranging from 0 (no disability) to 16 (greatest possible disability).
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
Time Frame: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection
Evaluation for the change of degree for the motion of shoulder, checked with an inclinometer, as a passive maneuver, in the supine position
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
Time Frame: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection
Evaluation for the change of degree for the motion of shoulder, checked with an inclinometer, as a passive maneuver, in the supine position
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
Time Frame: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection
Evaluation for the change of area for the intra-sheath fluid, checked and calculated ultrasonographically at the upper portion of the bicipital groove of the humerus.
Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veterans Health Service Medical Center, Seoul, Korea

Investigators

  • Study Director: Wonjae Lee, MD, Ph D, Veterans Health Service Medical Center, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2017

Primary Completion (Actual)

March 27, 2019

Study Completion (Actual)

July 16, 2019

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 13, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 13, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-03-011-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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