National Taiwan University Hospital, Bei-Hu branch
Taipei, Taiwan, Province of China, 23562, Taiwan
NCT Number: NCT03148353
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.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Taipei, Taiwan, Province of China, 23562, Taiwan
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
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) Chi-square test (2) Fisher exact test: sparse data
Multivariate analysis:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Within 3 months after injection
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.
Time frame: within 3 months after injection
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.
Time frame: within 3 months after injection
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.
National Taiwan University Hospital
Other
Comparative Effectiveness of the Standardized and Modified Ultrasound Guided Corticosteroid Subacromial Injection for Participants With Shoulder Impingement Syndrome
Acronym: SMCSINJ
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