Calcific Tendinitis: Comparing Minimally Invasive Modalities
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of Western Ontario Rotator Cuff (WORC) score
研究概览
简要总结
Calcific tendinitis is a common and challenging problem in the orthopedic surgeon's office. The chronic and variable course of the condition can lead to dissatisfaction with conservative management. Current standard of care at the Thunder Bay Regional Health Sciences Centre is referral for treatment by either needle decompression therapy by a radiologist or shockwave therapy by a physiotherapist. The purpose of this study is to compare the efficacies of these treatment options.
详细描述
Calcific tendinitis is a common and challenging problem in the orthopedic surgeon's office. The chronic and variable course of the condition can lead to dissatisfaction with conservative management. Current guidelines recommend conservative management initially and failing this, a variety of minimally invasive options exist. These include subacromial steroid injection (SSI), needle decompression (ND), and Shock wave therapy (SWT).
Few trials of these methods exist, but generally a benefit is seen with all minimally invasive methods. Most promising results have occurred with needle decompression and shockwave therapy. To date, no direct trials comparing SWT and ND have been published.
The purpose of this trial is to preliminarily establish the comparative efficacies of NDSSI and SWT using a number of outcome measures. Secondarily, the investigators aim to determine prognostic factors for success of minimally invasive therapies. The results of this study will serve as a foundation for more rigorous trials in this area.
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
- Single (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
- •New diagnosis of symptomatic calcific tendinitis of the shoulder
- •Seeking treatment for diagnosis
- •≥ 18 years of age
排除标准
- •Pre-existing diagnosis of rotator cuff tear or arthropathy
- •Previous minimally invasive or surgical therapy
- •Systemic Inflammatory disease
- •Blood dyscrasia
- •Peripheral neuropathy
- •Active Workplace Safety & Insurance Board (WSIB) claim for shoulder injury
研究组 & 干预措施
NDSSI
Participants in this arm of the trial will be referred for Needle decompression with subacromial steroid (Depo medrol) injection (NDSSI) as their treatment for calcific tendinitis
干预措施: Needle decompression (Procedure)
NDSSI
Participants in this arm of the trial will be referred for Needle decompression with subacromial steroid (Depo medrol) injection (NDSSI) as their treatment for calcific tendinitis
干预措施: Depo medrol (Drug)
SWT
Participants in this arm of the trial will be referred for Shockwave therapy (SWT) using an Ultrasound device, delivered by a physiotherapist, as their treatment for calcific tendinitis
干预措施: Shockwave therapy (Procedure)
SWT
Participants in this arm of the trial will be referred for Shockwave therapy (SWT) using an Ultrasound device, delivered by a physiotherapist, as their treatment for calcific tendinitis
干预措施: Ultrasound device (Device)
结局指标
主要结局
Change of Western Ontario Rotator Cuff (WORC) score
时间窗: Baseline, 3 months, 1 year
Change in a participant's WORC scores from baseline to 3 months and 1 year. WORC is a condition-specific outcome tool for people with rotator cuff disorder. A total score for each domain is calculated (Physical Symptoms/600; Sports and Recreation/400; Work/400 and Lifestyle/400;Emotions/400) and the total score for the domains is summed for an aggregate score out of 2100.
Change of Gartland Classification of X-ray
时间窗: Baseline, 3 months, 1 year
The change in radiographic resolution as measured by the Gartland Classification scale (1-4) from baseline to 3 months and 1 year.
Change of Range of Motion
时间窗: Baseline, 3 months, 1 year
The change in a Participant's Range of Motion as measured by a goniometer (Passive Range of Motion \[PROM\] and Assistive Range of Motion \[AROM\]) from baseline to 3 months and 1 year.
次要结局
- The change in overall health as measured by the SF-8(Baseline, 3 months, 1 year)
研究者
Jubin Payandeh
Orthopedic Surgeon, Assistant Professor
Lakehead University