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

October 23, 2018 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taiwan, Province OF China
      • Taipei, Taiwan, Province OF China, Taiwan, 23562
        • National Taiwan University Hospital, Bei-Hu Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 3 months after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 3 months after injection
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.
within 3 months after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Ke-Vin Chang, MD, National Taiwan University Hospital, Bei-Hu Branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2017

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

April 27, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (Actual)

May 11, 2017

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201701028RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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