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Completed

NCT Number: NCT04347733

Hyaluronidase in Intra-articular Steroid Injection Treating the 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.

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Key information

Conditions

Adhesive Capsulitis of Shoulder Bursitis Joint Diseases Musculoskeletal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Veterans Health Service Medical Center

Seoul, 05368, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triamcinolone Acetonide 40mg/mL

Drug

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.

Hyaluronidase Injection

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

  2. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Veterans Health Service Medical Center, Seoul, Korea

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 15, 2020
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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