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Adhesive Capsulitis of ShoulderPhase 3NCT04347733

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

A Phase 3 study testing Triamcinolone Acetonide 40mg/mL and Hyaluronidase Injection in people with Adhesive Capsulitis of Shoulder, run by Veterans Health Service Medical Center, Seoul, Korea at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Adhesive Capsulitis of Shoulder
What is being tested?
Triamcinolone Acetonide 40mg/mL and Hyaluronidase Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
2 May 2017to 16 Jul 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Veterans Health Service Medical Center

    Seoul, 05368

Other trials in South Korea

About this study

Official title: Additive Effects of Hyaluronidase in Intra-articular Steroid Injection Treating the Initial Stage of 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.

Read the 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.

Being tested
Triamcinolone Acetonide 40mg/mL, Hyaluronidase Injection
Keywords
Intra-articular injections, Steroids, Hyaluronidase, Ultrasonography
Medical subject headings
Bursitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Triamcinolone Acetonide 40mg/mLDrug

    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 InjectionDrug

    Also called Hirax Inj® BMI KOREA Pharmaceutical, South Korea

    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.

Study groups in NCT04347733
Study groupRoleWhat they receive
Group AExperimentalIntra-articular injection, 20 mg (0.5 mL) of triamcinolone acetonide mixed with 2 mL of 2% lidocaine and 7.5 mL of normal saline
Receives: Drug: Triamcinolone Acetonide 40mg/mL
Group BExperimental40 mg (1 mL) of triamcinolone acetonide mixed with 2 mL of 2% lidocaine and 7.0 mL of normal saline
Receives: Drug: Triamcinolone Acetonide 40mg/mL
Group CActive comparator20 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
Receives: Drug: Triamcinolone Acetonide 40mg/mL; Drug: Hyaluronidase Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection

Secondary outcomes (4)

  1. 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).

    Measured: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection

  2. 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

    Measured: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection

  3. 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

    Measured: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection

  4. 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.

    Measured: Evaluation at 5 time intervals: before injection and at 2, 4, 8, and 16 weeks after the injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2020
  2. Study start2 May 2017
  3. Primary completion27 Mar 2019
  4. Study completion16 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04347733
Sponsor's protocol ID
2017-03-011-001
Status last verified
Apr 2020
First submitted
9 Apr 2020
Last updated
15 Apr 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fields BKK, Skalski MR, Patel DB, White EA, Tomasian A, Gross JS, Matcuk GR Jr. Adhesive capsulitis: review of imaging findings, pathophysiology, clinical presentation, and treatment options. Skeletal Radiol. 2019 Aug;48(8):1171-1184. doi: 10.1007/s00256-018-3139-6. Epub 2019 Jan 3.

    PubMed 30607455

  • Ahn JH, Lee DH, Kang H, Lee MY, Kang DR, Yoon SH. Early Intra-articular Corticosteroid Injection Improves Pain and Function in Adhesive Capsulitis of the Shoulder: 1-Year Retrospective Longitudinal Study. PM R. 2018 Jan;10(1):19-27. doi: 10.1016/j.pmrj.2017.06.004. Epub 2017 Jun 12.

    PubMed 28619380

  • Tandon A, Dewan S, Bhatt S, Jain AK, Kumari R. Sonography in diagnosis of adhesive capsulitis of the shoulder: a case-control study. J Ultrasound. 2017 Aug 21;20(3):227-236. doi: 10.1007/s40477-017-0262-5. eCollection 2017 Sep.

    PubMed 28900523

  • Byun SD, Park DH, Hong YH, Lee ZI. The additive effects of hyaluronidase in subacromial bursa injections administered to patients with peri-articular shoulder disorder. Ann Rehabil Med. 2012 Feb;36(1):105-11. doi: 10.5535/arm.2012.36.1.105. Epub 2012 Feb 29.

    PubMed 22506242

  • Buhren BA, Schrumpf H, Hoff NP, Bolke E, Hilton S, Gerber PA. Hyaluronidase: from clinical applications to molecular and cellular mechanisms. Eur J Med Res. 2016 Feb 13;21:5. doi: 10.1186/s40001-016-0201-5.

    PubMed 26873038

  • Cho CH, Song KS, Kim BS, Kim DH, Lho YM. Biological Aspect of Pathophysiology for Frozen Shoulder. Biomed Res Int. 2018 May 24;2018:7274517. doi: 10.1155/2018/7274517. eCollection 2018.

    PubMed 29992159

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Triamcinolone Acetonide 40mg/mL and Hyaluronidase Injection in people with Adhesive Capsulitis of Shoulder, run by Veterans Health Service Medical Center, Seoul, Korea at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04347733, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.

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