Dual-target Ultrasound Guided Corticosteroid Injection for Shoulder Impingement Syndrome

NCT04219527 | Unknown

• 1 other identifier: 201910036RINC
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Subacromial injection is considered one of the best treatments for patients with subacromial impingement syndrome. The subacromial bursa is located between the deltoid muscle and the supraspinatus tendon. It facilitates the gliding of the humeral head through the undersurface of the acromion. If the bursa is thickened, the patient may experience pain when he/she tries to raise the arm. In patients with subacromial impingement due to a thickened subacromial bursa, the physician can precisely inject the medication into the bursa using ultrasound guidance. Use of ultrasound guidance has been proven to yield a better effect of pain relief than the technique using guidance. A previous study found that even using ultrasound guidance to deliver medication, there were still many patients suffering from initial treatment failure or recurrence after the first successful injection. Because the pathophysiological mechanism of subacromial impingement is complexed, the proximal biceps tendon may be involved but is often ignored. Recently, the investigators published a randomized controlled trial comparing the effect of dual-target injection (proximal biceps tendon and subacromial bursa) with the standard subacromial injection in patients with subacromial impingement syndrome, and found that the dual target approach was safe and had a longer effective duration than the standard subacromial injection. In this regard, the investigators will conduct a longitudinal follow-up study to examine the long-term effectiveness of the dual-target corticosteroid injection for subacromial impingement syndrome.

Conditions

Shoulder Impingement

Keywords

Shoulder impingement; Subacromial bursa; Biceps tendon

Outcome Measures

Primary Outcomes (1)

• Change in shoulder pain and disability index (SPADI)

  Shoulder pain and disability index (SPADI). The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.

  Within 1 year after injection

Secondary Outcomes (4)

• Change in visual analogue scale of pain

  Within 1 year after injection

• Doppler image of the rotator cuff tendons

  Within 1 year after injection

• Elasticity (strain ratio) of the rotator cuff tendons

  Within 1 year after injection

• Dynamic ultrasound evaluation

  Within 1 year after injection

Study Arms (1)

Dual-Target injection

EXPERIMENTAL

Corticosteroid injection into the subacromial bursa and biceps tendon

Procedure: Dual-target injection

Interventions

Dual-target injection PROCEDURE

Intervention procedure: corticosteroid injection into the subacromial bursa and biceps tendon Device for guidance: high-resolution ultrasound Drug: 40 mg triamcinolone acetonide (a kind of corticosteroid) + 3 mL of lidocaine (the medication will be mixed with 40 mg triamcinolone acetonide)

Dual-Target injection

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• shoulder pain\>3 weeks; no contraindication for local injection; Visual analogue scale of pain\>4

You may not qualify if:

• systemic rheumatologic disease, Ankylosing spondylitis, malignancy, major trauma or recent injections on the affected shoulder
• The healthy volunteers are defined as no shoulder pain, and are only for the assessment of the inter-rater and intra-rater reliability of the ultrasound evaluation, without intervention.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, Bei-Hu branch

Taipei, 108, Taiwan

RECRUITING

Related Publications (1)

• Wu WT, Lin CY, Shu YC, Chen LR, Ozcakar L, Chang KV. Predictive value of subacromial motion metrics for the effectiveness of ultrasound-guided dual-target injection: a longitudinal follow-up cohort trial. Insights Imaging. 2025 Jul 1;16(1):145. doi: 10.1186/s13244-025-01989-5.

  PMID: 40593369 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Study Officials

• Ke-Vin Chang

  National Taiwan University Hospital Bei-Hu Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-Vin Chang, MD

CONTACT

+886-23717101; pattap@pchome.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 7, 2020
• Study Start: November 12, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 13, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)