Adhesive Capsulitis of Shoulder
Conditions
Keywords
Intra-articular injections, Steroids, Hyaluronidase, Ultrasonography
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.
Interventions
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.
DRUGHyaluronidase 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.
Sponsors
Veterans Health Service Medical Center, Seoul, Korea
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of visual analogue scale (VAS) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of shoulder disability questionnaire (SDQ) | 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). |
| 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 | 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 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 |
| 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 | 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. |
Countries
South Korea
Outcome results
None listed