Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection: A Randomized Controlled Double-Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) Score at Visit 1
研究概览
简要总结
The purpose of this study is to determine the efficacy of barbotage therapy by comparing the clinical and sonographic changes in patients that solely receive barbotage to patients receiving the standard of care, barbotage with cortisone injection.
详细描述
Calcific tendonitis is a condition caused by calcium deposits building up in a person's muscles or tendons. If calcium builds up in an area, a person may feel pain and discomfort there. The purpose of this study is to determine the efficacy of barbotage therapy (injecting and washing the shoulder joint with saline) by comparing the amount of pain, shoulder function, and X-Rays in patients with calcific tendonitis that receive the standard of care, barbotage with cortisone injection, against barbotage with saline injection. Receiving barbotage without cortisone is therefore considered experimental.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be at least 18 years of age and younger than 90 years of age
- •Diagnosed with calcific tendonitis and ruled out other shoulder-related pathologies
- •Failed 1st line therapy (physical therapy and cortisone injection)
- •Intention to receive barbotage with cortisone as standard of care
- •3 or more months of shoulder pain
- •Finding of one or more calcifications ≥5 mm in size on either sonogram or radiograph, located on the supraspinatus tendon
- •Positive Hawkin's test or Neer's sign for impingement
排除标准
- •Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
- •Osteoarthritis of the glenohumeral joint of the affected shoulder
- •Previous surgery or barbotage to the affected shoulder
- •History of prior allergic/hypersensitivity reactions related to the study medication
- •Shoulder instability, glenohumeral arthritis, AC pathology, inflammatory arthropathy, fibromyalgia, frozen shoulder or cervical radiculopathy
- •Sub-acromial injection with a corticosteroid or treatment by ESWT during the last 3 months before inclusion
- •Younger than 18 years of age or older than 90
- •Any patient considered a vulnerable subject
研究组 & 干预措施
Barbotage Injection
Subjects receiving barbotage with saline injection
干预措施: Barbotage (Drug)
Barbotage with Cortisone Injection
Subjects receiving barbotage with cortisone injection
干预措施: Barbotage (Drug)
Barbotage with Cortisone Injection
Subjects receiving barbotage with cortisone injection
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Visual Analog Scale (VAS) Score at Visit 1
时间窗: Visit 1 (Day 0)
Pain will be assessed by the Visual Analog Scale which describes pain in terms of no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
VAS Score at Visit 2
时间窗: Visit 2 (Week 6)
Pain will be assessed by the Visual Analog Scale which describes pain in in terms of no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
VAS Score at Visit 3
时间窗: Visit 3 (Month 3)
Pain will be assessed by the Visual Analog Scale which describes pain in terms or sdlk no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
QuickDASH Score at Visit 1
时间窗: Visit 1 (Day 0)
Individual's ability to complete tasks, absorb forces, and severity of symptoms are measured by a 11-item QuickDash questionnaire using a 5 point Likert scale. The raw score is the sum of responses and is rescaled into a total score ranging from 0-100; lower scores indicate greater abilities.
Radiographic Size of Calcium Deposit at Visit 4
时间窗: Visit 4 (Month 6)
Size of calcium deposit will be assessed with Shoulder X-rays.
American Shoulder and Elbow Surgeons (ASES) Index Score at Visit 1
时间窗: Visit 1 (Day 0)
24-item assessment of pain and daily living related to shoulder conditions. Items are rated on various Likert scales. The raw score is the sum of responses and is converted to a total score. Total scores range from 0 to 100; higher scores indicate a better shoulder condition.
VAS Score at Visit 4
时间窗: Visit 4 (Month 6)
Pain will be assessed by the Visual Analog Scale which describes pain in no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
QuickDASH Score at Visit 4
时间窗: Visit 4 (Month 6)
Individual's ability to complete tasks, absorb forces, and severity of symptoms are measured by a 11-item QuickDash questionnaire using a 5 point Likert scale. The raw score is the sum of responses and is rescaled into a total score ranging from 0-100; lower scores indicate greater abilities.
ASES Index Score at Visit 4
时间窗: Visit 4 (Month 6)
24-item assessment of pain and daily living related to shoulder conditions. Items are rated on various Likert scales. The raw score is the sum of responses and is converted to a total score. Total scores range from 0 to 100; higher scores indicate a better shoulder condition.
Radiographic Size of Calcium Deposit at Visit 1
时间窗: Visit 1 (Day 0)
Size of calcium deposit will be assessed with Shoulder X-rays.
次要结局
未报告次要终点