Dual-target Ultrasound Guided Corticosteroid Injection for Shoulder Impingement Syndrome

NCT ID: NCT04219527

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-12
• Study Completion Date: 2022-10-01

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.

Detailed Description

Introduction:

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.

Material and methods:

Participants: adult patients (>20 year old) with shoulder impingement syndrome Inclusion criteria: shoulder pain>3 weeks; no contraindication for local injection; Visual analogue scale of pain>4 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

Participant number: 210 (150 with subacromial impingement, and 60 of healthy subjects) Exclusion criteria: systemic rheumatologic disease, Ankylosing spondylitis, malignancy, major trauma or recent injections on the affected shoulder

Study design:

The aims of this study is (1) set up the inter-rater and intra-rater reliability of the ultrasound evaluation in patients with subacromial impingement and healthy subjects (2) longitudinal follow up the therapeutic effect of dual-target injection to subacromial bursa and biceps tendon sheath only in patients with subacromial impingement

Detail of the intervention Single arm experiment: ultrasound guided injection into the subacromial bursa and biceps tendon sheath in patients with subacromial impingements, with 40 mg triamcinolone acetonide plus 3 mL of lidocaine

Outcome measurement:

physical examination(bicipital groove compression test, Speed's test, Yergason's test, empty can test, Neer's impingement test, Hawkins-Kennedy impingement test, painful arc test), range of motion as the baseline information. Visual analogue scale of pain, shoulder pain and disability index (SPADI), shoulder sonography (gray-scale/elastography)

Statistical analysis:

Continuous variables

1. Student's t test: fit assumption of normal distribution

2. Mann-Whitney test: does not fit the assumption of normal distribution

Categorical variables

(1) Chi-square test (2) Fisher exact test: sparse data

Multivariate analysis:

1. Linear regression

2. Logistic regression

Keywords: ultrasonography, corticosteroid, subacromial impingement syndrome, shoulder pain, longitudinal follow-up

Conditions

Shoulder Impingement

Keywords

Shoulder impingement; Subacromial bursa; Biceps tendon

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dual-Target injection

Corticosteroid injection into the subacromial bursa and biceps tendon

Group Type: EXPERIMENTAL

Dual-target injection

Intervention Type: 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)

Interventions

Dual-target injection

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)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ke-Vin Chang

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital Bei-Hu Branch

Locations

National Taiwan University Hospital, Bei-Hu branch

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ke-Vin Chang, MD

Role: CONTACT

Phone: +886-23717101

Email: pattap@pchome.com.tw

Facility Contacts

Ke-Vin Chang, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 40593369 (View on PubMed)

Other Identifiers

201910036RINC

Identifier Type: -

Identifier Source: org_study_id