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

Standardized and Modified Corticosteroid Subacromial Injection for Shoulder Impingement Syndrome

Sponsors

Lead sponsor: National Taiwan University Hospital

Source National Taiwan University Hospital
Brief 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.

Detailed 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

Overall Status Completed
Start Date May 30, 2017
Completion Date October 1, 2018
Primary Completion Date October 1, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in shoulder pain and disability index (SPADI) Within 3 months after injection
Secondary Outcome
Measure Time Frame
Change in visual analogue scale of pain within 3 months after injection
Change in elasticity (strain ratio) within 3 months after injection
Enrollment 60
Condition
Intervention

Intervention type: Procedure

Intervention name: Subacromial injection

Description: Modified ultrasound guided corticosteroid subacromial injection Standardized ultrasound guided corticosteroid subacromial injection

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

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Ke-Vin Chang, MD Principal Investigator National Taiwan University Hospital, Bei-Hu Branch
Location
facility
National Taiwan University Hospital, Bei-Hu branch
Location Countries

Taiwan

Verification Date

May 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Modified subacromial injection

Arm group type: Experimental

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

Arm group label: Standardized subacromial injection

Arm group type: Placebo Comparator

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

Acronym SMCSINJ
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: randomized controlled trial

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Masking description: The treatment is double blind to the participants and outcome assessors. Only the physician performs the injection knows which kind of intervention the patients receive.

Source: ClinicalTrials.gov