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

Study Overview
=================
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.

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

Conditions
-----------------
Adhesive Capsulitis of Shoulder

Intervention / Treatment
-----------------
* Drug: Triamcinolone Acetonide 40mg/mL
* Drug: Hyaluronidase Injection


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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<br>* 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.<br>|
| Experimental: Group B<br>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<br>* 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.<br>|
| Active Comparator: Group C<br>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<br>* 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.<br>Drug: Hyaluronidase Injection<br>* 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.<br>* 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) | 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) | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intra-articular injections, Steroids, Hyaluronidase, Ultrasonography