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临床试验/NCT07113639
NCT07113639已完成不适用

Effectiveness of High-volume Corticosteroid Injection Diluted With Saline in Subacromial Impingement Syndrome: A Prospective Randomized Trial

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Shoulder Pain and Disability Index score

研究概览

简要总结

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.

详细描述

Subacromial impingement syndrome (SIS) is commonly treated conservatively with corticosteroid (CS) injections into the subacromial bursa, often combined with local anesthetics (LA). Despite widespread use, there remains no consensus regarding the optimal injection technique, volume, or drug formulation. Some studies suggest high-volume injections may provide superior pain relief, while others show no significant difference. To clarify this, a prospective, double-blind, randomized controlled trial was designed to compare the efficacy and safety of high-volume versus low-volume CS injections in patients with SIS.

Material and methods:

This study is a prospective, double-blind, randomized controlled trial. The study procedure was discussed with the patients, and each participant provided written informed consent.

All patients who were admitted to the outpatient clinic with unilateral shoulder pain within the study period, were screened to assess eligibility for the study The following 3-step checklist was completed for an accurate diagnosis of SIS: history of anterolateral arm pain and exacerbation of symptoms upon raising the shoulder to 90° or higher, a combination of the Neer test, Hawkins-Kennedy test, painful-arc test, and infraspinatus muscle test produced at least 2 positive results and confirmation of the diagnosis by an ultrasound (US) evaluation of the affected shoulder.

The same physiatrist (who had 5 years of experience in musculoskeletal US) performed the complete standard US evaluation of the affected shoulder in each patient, according to the EURO-MUSCULUS/USPRM shoulder scanning protocol. All patients also underwent dynamic US evaluation for SIS . A 3-16-mHz linear probe was used in B mode (Samsung HM70A Plus, Seoul, South Korea). For the US diagnosis of SIS, the subacromial-subdeltoid bursa must have been thicker than 2 mm (bursitis) and a sign of impingement must have been seen on the dynamic evaluations. Any pathological abnormalities associated with SIS (tendinosis, partial-thickness rotator cuff tear, etc.) were also noted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

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).

干预措施: Injection (Procedure)

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)

干预措施: Injection (Procedure)

结局指标

主要结局

Shoulder Pain and Disability Index score

时间窗: evaluated at 4 and 12 weeks before injection

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 .

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

İsa Cüce

Associate Professor

TC Erciyes University

研究点 (1)

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