Hyaluronidase in Intra-articular Steroid Injection Treating the Adhesive Capsulitis for Shoulder
- Conditions
- Adhesive Capsulitis of Shoulder
- Interventions
- Registration Number
- NCT04347733
- Lead Sponsor
- Veterans Health Service Medical Center, Seoul, Korea
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group A Triamcinolone Acetonide 40mg/mL 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 Group B Triamcinolone Acetonide 40mg/mL 40 mg (1 mL) of triamcinolone acetonide mixed with 2 mL of 2% lidocaine and 7.0 mL of normal saline Group C Triamcinolone Acetonide 40mg/mL 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 Group C Hyaluronidase Injection 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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
Trial Locations
- Locations (1)
Veterans Health Service Medical Center
🇰🇷Seoul, Korea, Republic of