Standardized and Modified Corticosteroid Subacromial Injection for Shoulder Impingement Syndrome

NCT03148353 | Completed

• 1 other identifier: 201701028RIND
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Impingement

Keywords

ultrasonography, corticosteroid, subacromial impingement syndrome, shoulder pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 3 months after injection

Secondary Outcomes (2)

• Change in visual analogue scale of pain

  within 3 months after injection

• Change in elasticity (strain ratio)

  within 3 months after injection

Study Arms (2)

Modified subacromial injection

EXPERIMENTAL

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

Standardized subacromial injection

PLACEBO COMPARATOR

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

Interventions

Subacromial injection PROCEDURE

1. Modified ultrasound guided corticosteroid subacromial injection 2. Standardized ultrasound guided corticosteroid subacromial injection

Modified subacromial injection; Standardized subacromial injection

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• shoulder pain\>3 weeks; no contraindication for local injection; Visual analogue scale of pain\>4

You may not qualify if:

• systemic rheumatologic disease, Ankylosing spondylitis, malignancy, major trauma or recent injections on the affected shoulder

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, Bei-Hu branch

Taipei, Taiwan, Province of China, 23562, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 28245972 RESULT

• 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.

  PMID: 26717970 RESULT

• 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.

  PMID: 33338463 DERIVED

• 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.

  PMID: 31150601 DERIVED

Related Links

• Static and Dynamic Shoulder Imaging to Predict Initial Effectiveness and Recurrence After Ultrasound-guided Subacromial Corticosteroid Injections. Archive of Physical Medicine and Rehabilitation. 2017
• Ultrasound-Guided Versus Blind Subacromial Corticosteroid Injections for Subacromial Impingement Syndrome: A Randomized, Double-Blind Clinical Trial. Am J Sports Med. 2016

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ke-Vin Chang, MD

  National Taiwan University Hospital Bei-Hu Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 11, 2017
• Study Start: May 30, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 25, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)