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

Primary Purpose

Shoulder Impingement

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Subacromial injection
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement focused on measuring ultrasonography, corticosteroid, subacromial impingement syndrome, shoulder pain

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital, Bei-Hu branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Modified subacromial injection

Standardized subacromial injection

Arm 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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 27, 2017
Last Updated
October 23, 2018
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03148353
Brief Title
Standardized and Modified Corticosteroid Subacromial Injection for Shoulder Impingement Syndrome
Acronym
SMCSINJ
Official Title
Comparative Effectiveness of the Standardized and Modified Ultrasound Guided Corticosteroid Subacromial Injection for Participants With Shoulder Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 Control group: ultrasound guided injection into the subacromial bursa with 40 mg triamcinolone acetonide plus 3 mL of lidocaine 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 Student's t test: fit assumption of normal distribution 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: Linear regression Logistic regression Keywords: ultrasonography, corticosteroid, subacromial impingement syndrome, shoulder pain

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement
Keywords
ultrasonography, corticosteroid, subacromial impingement syndrome, shoulder pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified subacromial injection
Arm Type
Experimental
Arm 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 Title
Standardized subacromial injection
Arm Type
Placebo Comparator
Arm 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)
Intervention Type
Procedure
Intervention Name(s)
Subacromial injection
Intervention Description
Modified ultrasound guided corticosteroid subacromial injection Standardized ultrasound guided corticosteroid subacromial injection
Primary Outcome Measure Information:
Title
Change in shoulder pain and disability index (SPADI)
Description
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
Secondary Outcome Measure Information:
Title
Change in visual analogue scale of pain
Description
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
Title
Change in elasticity (strain ratio)
Description
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.
Time Frame
within 3 months after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ke-Vin Chang, MD
Organizational Affiliation
National Taiwan University Hospital, Bei-Hu Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital, Bei-Hu branch
City
Taipei
State/Province
Taiwan, Province OF China
ZIP/Postal Code
23562
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28245972
Citation
Chang KV, Wu WT, Han DS, Ozcakar 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.2017.01.022. Epub 2017 Feb 27.
Results Reference
result
PubMed Identifier
26717970
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: 10.1177/0363546515618653. Epub 2015 Dec 30.
Results Reference
result
PubMed Identifier
33338463
Citation
Hsu PC, Chang KV, Wu WT, Wang JC, Ozcakar L. Effects of Ultrasound-Guided Peritendinous and Intrabursal Corticosteroid Injections on Shoulder Tendon Elasticity: A Post Hoc Analysis of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):905-913. doi: 10.1016/j.apmr.2020.11.011. Epub 2020 Dec 15.
Results Reference
derived
PubMed Identifier
31150601
Citation
Wang JC, Chang KV, Wu WT, Han DS, Ozcakar L. Ultrasound-Guided Standard vs Dual-Target Subacromial Corticosteroid Injections for Shoulder Impingement Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Nov;100(11):2119-2128. doi: 10.1016/j.apmr.2019.04.016. Epub 2019 May 29.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/28245972
Description
Static and Dynamic Shoulder Imaging to Predict Initial Effectiveness and Recurrence After Ultrasound-guided Subacromial Corticosteroid Injections. Archive of Physical Medicine and Rehabilitation. 2017
URL
http://www.ncbi.nlm.nih.gov/pubmed/26717970
Description
Ultrasound-Guided Versus Blind Subacromial Corticosteroid Injections for Subacromial Impingement Syndrome: A Randomized, Double-Blind Clinical Trial. Am J Sports Med. 2016

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Standardized and Modified Corticosteroid Subacromial Injection for Shoulder Impingement Syndrome

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