Standardized and Modified Corticosteroid Subacromial Injection for Shoulder Impingement Syndrome

Shoulder Impingement Clinical Trial

— SMCSINJ  

Official title:

Comparative Effectiveness of the Standardized and Modified Ultrasound Guided Corticosteroid Subacromial Injection for Participants With Shoulder Impingement Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148353
• Other study ID #: 201701028RIND
• Status: Completed
• Phase: N/A
• Start date: May 30, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: May 2017
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subacromial injection is a useful procedure to counteract shoulder impingement syndrome. With the aid of high‐resolution ultrasound, the needle can be introduced precisely into the subacromial/subdeltoid bursa located between the acromion above and the supraspinatus tendon below. The standardized method allows the injectate to distribute along the subdeltoid bursa, further reliving pain from subacromial/subdeltoid impingement. In a substantial part of shoulder pain patients, it is common to accompany pain along the bicipital groove, which the biceps long head tendon courses through. The biceps long head tendon is attached to the superior labrum of the glenoid cavity and acts as the second important structure to prevent upward migration of the humeral head, following the supraspinatus tendon. Overuse injury of the biceps tendon is a likely cause of anterior shoulder pain. Concomitant administration of medication into the subacromial bursa and biceps tendon sheath is theoretically more effective than injection to the subacromial bursa only because the formal procedure targets two vulnerable structures in shoulder impingement syndrome at once. Regarding the standard ultrasound‐guided subacromial injection. Therefore, we will conduct a randomized controlled trial investigating the effectiveness of standard subacromial injection in comparison with a novel approach simultaneously injecting the subacromial bursa and biceps tendon sheath.

Description:

Introduction Subacromial injection is a useful procedure to counteract shoulder impingement syndrome. With the aid of high‐resolution ultrasound, the needle can be introduced precisely into the subacromial/subdeltoid bursa located between the acromion above and the supraspinatus tendon below. The standardized method allows the injectate to distribute along the subdeltoid bursa, further reliving pain from subacromial/subdeltoid impingement. In a substantial part of shoulder pain patients, it is common to accompany pain along the bicipital groove, which the biceps long head tendon courses through. The biceps long head tendon is attached to the superior labrum of the glenoid cavity and acts as the second important structure to prevent upward migration of the humeral head, following the supraspinatus tendon. Overuse injury of the biceps tendon is a likely cause of anterior shoulder pain. Concomitant administration of medication into the subacromial bursa and biceps tendon sheath is theoretically more effective than injection to the subacromial bursa only because the formal procedure targets two vulnerable structures in shoulder impingement syndrome at once. Regarding the standard ultrasound‐guided subacromial injection. Therefore, we will conduct a randomized controlled trial investigating the effectiveness of standard subacromial injection in comparison with a novel approach simultaneously injecting the subacromial bursa and biceps tendon sheath.

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 Participant number: at least 30 at each treatment arm Exclusion criteria: systemic rheumatologic disease, Ankylosing spondylitis, malignancy, major trauma or recent injections on the affected shoulder Study design: single center double blind randomized controlled trial Randomization method: block randomization (block size: 4), computerized random sequence generation, allocation concealment (+) Detail of the intervention

1. Control group: ultrasound guided injection into the subacromial bursa with 40 mg triamcinolone acetonide plus 3 mL of lidocaine

2. Experimental group: ultrasound guided injection into the subacromial bursa and biceps tendon sheath with 40 mg triamcinolone acetonide plus 3 mL of lidocaine

Outcome measurement:

Visual analogue scale of pain, 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, 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Impingement
• Shoulder Impingement Syndrome

Intervention

Procedure:
• Subacromial injection
Modified ultrasound guided corticosteroid subacromial injection Standardized ultrasound guided corticosteroid subacromial injection

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, Bei-Hu branch	Taipei	Taiwan, Province OF China

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Chang KV, Wu WT, Han DS, Özçakar L. Static and Dynamic Shoulder Imaging to Predict Initial Effectiveness and Recurrence After Ultrasound-Guided Subacromial Corticosteroid Injections. Arch Phys Med Rehabil. 2017 Oct;98(10):1984-1994. doi: 10.1016/j.apmr.20 — View Citation

Cole BF, Peters KS, Hackett L, Murrell GA. Ultrasound-Guided Versus Blind Subacromial Corticosteroid Injections for Subacromial Impingement Syndrome: A Randomized, Double-Blind Clinical Trial. Am J Sports Med. 2016 Mar;44(3):702-7. doi: 10.1177/0363546515 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 3 months after injection
Secondary	Change in visual analogue scale of pain	The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' . The patient is asked to mark his pain level on the line between the two endpoints.	within 3 months after injection
Secondary	Change in elasticity (strain ratio)	Change in tendon elasticity (strain ratio) after injection. Strain ratio is calculated for the target by selecting a region of interest (ROI) and a corresponding ROI of the adjacent reference tissue. Using machine inherent software, the strain ratio value is displayed on a static image.	within 3 months after injection

External Links

•   Static and Dynamic Shoulder Imaging to Predict Initial Effectiveness and Recurrence After Ultrasound-guided Subacromial Corticosteroid Injections. Archive of Physical Medicine and Rehabilitation. 2017
•   Ultrasound-Guided Versus Blind Subacromial Corticosteroid Injections for Subacromial Impingement Syndrome: A Randomized, Double-Blind Clinical Trial. Am J Sports Med. 2016