Effectiveness of High-Volume Corticosteroid Injection in Shoulder Impingement

NCT07113639 | Completed

• 1 other identifier: 2020-410
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the effectiveness of high-volume versus low-volume ultrasound-guided corticosteroid injections diluted with saline in patients with subacromial impingement syndrome, finding no significant difference in pain or functional outcomes between the two methods.

Conditions

Shoulder Impingement Syndrome

Keywords

shoulder pain; ultrasound; subacromial bursa; injection; different volumes

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain and Disability Index score

  This index assesses shoulder-related pain (5 items) and disability (8 items), for a total of 13 items. Each item is scored from 0 (no pain or difficulty) to 10 (worst pain or very difficult). The score is then converted to a 100-point scale, with higher scores reflecting higher levels of shoulder pain and disability .

  evaluated at 4 and 12 weeks before injection

Secondary Outcomes (3)

• Visual Analog Scale (VAS):

  before injection, 1 hour later, at 4 and 12 weeks

• Western Ontario Rotator Cuff Index Score

  evaluated at 4 and 12 weeks before injection

• Active Range of Motion

  evaluated at 4 and 12 weeks before injection

Study Arms (2)

High-Volume Corticosteroid Injection Group

EXPERIMENTAL

US-guided injection of 1 mL triamcinolone acetonide (40 mg), 1 mL 2% lidocaine, and 8 mL normal saline (total volume: 10 mL).

Procedure: Injection

Low-volume corticosteroid injection

ACTIVE COMPARATOR

US-guided injection of 1 mL triamcinolone acetonide (40 mg), 1 mL 2% lidocaine, and 1 mL normal saline (total volume: 3 mL)

Procedure: Injection

Interventions

Injection PROCEDURE

US-guided subacromial-subdeltoid injection with 1 mL triamcinolone acetonide (40 mg), 1 mL 2% lidocaine, and 8 mL normal saline (10 mL total)

High-Volume Corticosteroid Injection Group

Eligibility Criteria

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

You may qualify if:

• Diagnosis of subacromial impingement syndrome (SIS)
• Age over 18 years
• Shoulder pain lasting longer than 4 weeks
• Shoulder pain with a visual analogue scale (VAS) score of 3 or higher
• Passive shoulder range of motion within normal limits

You may not qualify if:

• Full-thickness tear or calcification of the rotator cuff in the affected shoulder
• Adhesive capsulitis
• History of trauma or surgery in the affected shoulder
• History of injection into the affected shoulder within the previous 6 months
• History of systemic rheumatic disease, malignancy, or coagulopathy
• Suspected cervical radiculopathy
• History of allergy to local anesthetics (LA) and/or corticosteroids (CS)

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Medicine Hospital

Kayseri, 38100, Turkey (Türkiye)

Location

Related Publications (3)

• Boonard M, Sumanont S, Arirachakaran A, Apiwatanakul P, Boonrod A, Kanchanatawan W, Kongtharvonskul J. Short-term outcomes of subacromial injection of combined corticosteroid with low-volume compared to high-volume local anesthetic for rotator cuff impingement syndrome: a randomized controlled non-inferiority trial. Eur J Orthop Surg Traumatol. 2018 Aug;28(6):1079-1087. doi: 10.1007/s00590-018-2149-3. Epub 2018 Feb 8.

  PMID: 29423865 RESULT

• Sumanont S, Boonard M, Peradhammanon E, Arirachakaran A, Suwankomonkul P, Oungbumrungpan W, Kongtharvonskul J. Comparative outcomes of combined corticosteroid with low volume compared to high volume of local anesthetic in subacromial injection for impingement syndrome: systematic review and meta-analysis of RCTs. Eur J Orthop Surg Traumatol. 2018 Apr;28(3):397-407. doi: 10.1007/s00590-017-2056-z. Epub 2017 Oct 12.

  PMID: 29027006 RESULT

• Ge M, Zhang Y, Li Y, Feng C, Tian J, Huang Y, Zhao T. Publication Trends and Hot Spots in Subacromial Impingement Syndrome Research: A Bibliometric Analysis of the Web of Science Core Collection. J Pain Res. 2022 Mar 28;15:837-856. doi: 10.2147/JPR.S348528. eCollection 2022.

  PMID: 35370418 RESULT

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain

Interventions

Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: October 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)