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临床试验/NCT06220643
NCT06220643已完成不适用

Prognosis and Effects of Ultrasound Guide Corticosteroid Injection with Progressive Resistance Exercise for Subacromial Bursitis: a Randomized Clinical Trial

Taipei Medical University Shuang Ho Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Shoulder Pain and Disability Index (SPADI)

研究概览

简要总结

Shoulder issues in middle-aged and elderly folks often stem from muscle and tendon degeneration, causing pain and limited movement. Current treatments like corticosteroid injections provide short-term relief for synovial bursitis, prompting repetitive injections. Combining these injections with resistance exercises, especially elastic bands, might extend relief. A study aims to test this by giving injections and a 12-week elastic band exercise program to one group, compared to injections alone in another. Assessments at 4, and 12 weeks post-injection will measure pain, motion, and functionality. Successful results could redefine treatment, reducing repetitive injections and enhancing life quality for those with shoulder problems.

详细描述

Shoulder activities are common among middle-aged and elderly individuals, often leading to degeneration of shoulder muscles and tendons. This degeneration causes instability, resulting in shoulder impingement syndrome and subsequent inflammation of the synovial bursa. Acute synovial bursitis leads to severe shoulder pain, limited movement, affecting daily life and work. Initial treatments like physical therapy and oral medication often fall short, necessitating corticosteroid injections into the subacromial bursa guided by ultrasound for effective relief. However, these injections often provide only short-term relief, leading to a need for repeated injections, causing concerns about side effects.

Previous research indicates that resistance-based exercises improve muscle strength and reduce shoulder tissue damage. Among these exercises, elastic band workouts are deemed safest for the elderly. Despite advancements in ultrasound-guided injections for subacromial bursitis, there's a scarcity of studies combining corticosteroid injections with progressive shoulder resistance exercises to prolong therapeutic effects.

This study aims to explore if progressive resistance exercises enhance and sustain the clinical benefits of ultrasound-guided corticosteroid injections in subacromial bursitis. It's a randomized double-single-blind study wherein the experimental group receives ultrasound-guided injections of 40mg triamcinolone acetonide and 2cc lidocaine into the inflamed bursa and undergoes a 12-week course of elastic band progressive resistance exercises. The control group only receives ultrasound-guided injections. Evaluators remain unaware of the group assignments. Parameters like VAS , ROM, and SPADI are assessed at 4, and 12 weeks post-injection.

This research seeks to ascertain whether combining corticosteroid injections with progressive resistance exercises prolongs the efficacy of treatment for subacromial bursitis. If successful, it could offer a novel approach to managing this condition, potentially reducing the need for repeated injections and improving the overall quality of life for middle-aged and elderly individuals affected by shoulder issues.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of subacromial bursitis of shoulder

排除标准

  • history of shoulder shoulder and operation history
  • comorbid with adhesive capsulitis or rotator cuff tear
  • received local injection of shoulder with steroid, hypertonic dextrose, hyaluronic acid or platelet-rich plasma in recent 6 months

研究组 & 干预措施

Echoguide steroid injection without exercise (only education)

Active Comparator

received 40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%) injected into the inflamed subacromial bursa with ultrasound guidance

干预措施: triamcinolone acetonide plus lidocaine (Drug)

Echoguide steroid injection with exercise

Experimental

experimental group received 40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%) injected into the inflamed subacromial bursa with ultrasound guidance, and a 12-week elastic band progressive resistance exercise

干预措施: resistance exercise (Other)

Echoguide steroid injection with exercise

Experimental

experimental group received 40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%) injected into the inflamed subacromial bursa with ultrasound guidance, and a 12-week elastic band progressive resistance exercise

干预措施: triamcinolone acetonide plus lidocaine (Drug)

结局指标

主要结局

Shoulder Pain and Disability Index (SPADI)

时间窗: Day 0, Month 1, Month 3

The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with ADLs requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items.

Visual Analogue Scale (VAS)

时间窗: Day 0, Month 1, Month 3

pain score from 0\~10, 0 means no pain, and 10 means extreme pain

次要结局

  • pain free range of motion(Day 0, Month 1, Month 3)

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ShihWei Huang

Attending Physician

Taipei Medical University Shuang Ho Hospital

研究点 (1)

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