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Standardized and Modified Corticosteroid Subacromial Injection for Shoulder Impingement Syndrome (SMCSINJ)

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ClinicalTrials.gov Identifier: NCT03148353
Recruitment Status : Completed
First Posted : May 11, 2017
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Shoulder Impingement Procedure: Subacromial injection Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial
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.
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of the Standardized and Modified Ultrasound Guided Corticosteroid Subacromial Injection for Participants With Shoulder Impingement Syndrome
Actual Study Start Date : May 30, 2017
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids Ultrasound

Arm Intervention/treatment
Experimental: Modified subacromial injection
  1. 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)
  2. 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)
Procedure: Subacromial injection
  1. Modified ultrasound guided corticosteroid subacromial injection
  2. Standardized ultrasound guided corticosteroid subacromial injection

Placebo Comparator: Standardized subacromial injection
  1. Intervention procedure: corticoseroid injection into the subacromial bursa only

    • Device for guidance: high-resolution ultrasound
    • Drug: 40 mg triamcinolone acetonide (a kind of corticosteroid)
  2. 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)
Procedure: Subacromial injection
  1. Modified ultrasound guided corticosteroid subacromial injection
  2. Standardized ultrasound guided corticosteroid subacromial injection




Primary Outcome Measures :
  1. Change in shoulder pain and disability index (SPADI) [ 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.


Secondary Outcome Measures :
  1. Change in visual analogue scale of pain [ 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.

  2. Change in elasticity (strain ratio) [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148353


Locations
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Taiwan
National Taiwan University Hospital, Bei-Hu branch
Taipei, Taiwan, Province OF China, Taiwan, 23562
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Ke-Vin Chang, MD National Taiwan University Hospital, Bei-Hu Branch

Additional Information:
Publications of Results:
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03148353     History of Changes
Other Study ID Numbers: 201701028RIND
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
ultrasonography, corticosteroid, subacromial impingement syndrome, shoulder pain

Additional relevant MeSH terms:
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Physiological Effects of Drugs
Rotator Cuff Injuries
Shoulder Impingement Syndrome
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases
Triamcinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors