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

Primary Purpose

Adhesive Capsulitis of Shoulder

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Triamcinolone Acetonide 40mg/mL

Hyaluronidase Injection

About this trial

This is an interventional treatment trial for Adhesive Capsulitis of Shoulder focused on measuring Intra-articular injections, Steroids, Hyaluronidase, Ultrasonography

Eligibility Criteria

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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

Sites / Locations

Veterans Health Service Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Arm 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

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change of shoulder disability questionnaire (SDQ)

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).

Change of degree for the abduction motion of shoulder

Evaluation for the change of degree for the motion of shoulder, checked with an inclinometer, as a passive maneuver, in the supine position

Change of degree for the flexion motion of shoulder

Evaluation for the change of degree for the motion of shoulder, checked with an inclinometer, as a passive maneuver, in the supine position

Change of area for the intra-sheath fluid

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.

Full Information

NCT ID

NCT04347733

First Posted

April 9, 2020

Last Updated

April 13, 2020

Sponsor

Veterans Health Service Medical Center, Seoul, Korea

1. Study Identification

Unique Protocol Identification Number

NCT04347733

Brief Title

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

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

May 2, 2017 (Actual)

Primary Completion Date

March 27, 2019 (Actual)

Study Completion Date

July 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Veterans Health Service Medical Center, Seoul, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adhesive Capsulitis of Shoulder

Keywords

Intra-articular injections, Steroids, Hyaluronidase, Ultrasonography

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Sequential Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm 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

Arm Title

Group B

Arm Type

Experimental

Arm Description

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

Arm Title

Group C

Arm Type

Active Comparator

Arm 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

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Acetonide 40mg/mL

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Hyaluronidase Injection

Other Intervention Name(s)

Hirax Inj® BMI KOREA Pharmaceutical, South Korea

Intervention Description

Primary Outcome Measure Information:

Title

Change of visual analogue scale (VAS)

Description

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

Time Frame