The Effectiveness of 4500 Joule Therapeutic Ultrasound in the Treatment of Calcific Tendinitis of the Shoulder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- The change in calcification size measured by D-ultrasound before and after the intervention.
研究概览
简要总结
Rotator cuff tendinitis (RCT) has a prevalence between 2.7 and 22%, and predominantly affects middle-aged women. The pathophysiology has not been fully elucidated to date. RCT is characterized by hydroxyapatite crystal deposition in the rotator cuff tendons. Approximately half of the patients with RCT have pain with acute or chronic shoulder mobility limitation. In some patients, RCT shows a tendency for spontaneous and rapid regression.
Diagnostic ultrasound (D-US) is a non-invasive, non-ionizing, and relatively inexpensive diagnostic imaging method that is safe and reliable in assessing rotator cuff pathology. It is very sensitive in the identification of calcifications that are shown in grayscale (B-mode) as hyperechoic structures with or without acoustic shadow. Based on ultrasound findings, Chiou HJ et al. have classified calcifications into 4 types: type I are arcuate, type II are fragmented or punctiform, type III are nodular, and type IV are cystic. Spontaneous resorption may occur with type III and IV calcifications. A positive Doppler signal (PD) surrounding the calcification is highly correlated with pain intensity.
According to the European Union of Medical Specialists-Physical and Rehabilitation Medicine (UEMS-PRM) guidelines, the basis of RCT therapy is individual medical gymnastics (IMG). It includes exercises aimed to restore full shoulder mobility, and improve rotator cuff and scapular stabilizer muscles strength. Other passive procedures are elective in the choice of treatment.
Ultrasound therapy is often used in the treatment of musculoskeletal shoulder pathology due to its thermal and non-thermal effects. It is considered that tissue heating stimulates healing (vasodilation, acceleration of the metabolism, and improvement of the viscoelastic properties of the connective tissue). The frequency of ultrasound therapy is selected depending on the desired depth of action (3 MHz for surface structures up to 2.5 cm depth, and 1 MHz for deeper structures, up to 5 cm depth). Pulse mode is commonly used in acute, while continuous in chronic conditions.
To date, only a few studies have evaluated the reduction in calcification size after ultrasound therapy. Although ultrasound therapy is routinely used in the treatment of painful shoulder, reviewing the results of research published so far, we can say that current knowledge about the effectiveness of ultrasound therapy in RCT is inconsistent (only several studies with a small number of subjects, different parameters of applied ultrasound therapy in terms of penetration depth, applied energy and duration of treatment). This indicates the need for further research.
详细描述
The research will be conducted in the Clinic for Rheumatic Diseases and Rehabilitation, University Hospital Center Zagreb. The research will be a double-blind randomized control prospective study. Randomization of patients will be performed before the intervention in the R software package and the results of the randomization will be known only to the therapist who will be involved in the treatment. The respondent and the examiner (doctor) will not be aware of in which group the patient is enrolled. All respondents will sign an informed consent before the study begins. Research has been approved by the Ethics Committee of Clinical Hospital Center Zagreb and the Ethics Committee of the School of Medicine, University of Zagreb.
The minimum sample size of a total of 42 subjects (21 in each group) was estimated according to the following characteristics: type 1 error (α = 0.05), power (1-β = 0.8) and effect size [(effect size) 0.2], with the expected use of two - way analysis of variance with two independent groups and two repeated measurements (2x2 ANOVA) with an estimated minimum correlation between repeated measurements r = 0.6.
Inclusion criteria are symptomatic RCT (VAS pain ≥ 4 + limited shoulder mobility) with D-US calcification size ≥ 5 mm, calcification type I and II according to Chiou HJ et al., and disease duration ≥ 2 months. Exclusion criteria are asymptomatic RCT or RCT with mild symptoms (VAS pain ≤ 3+ normal shoulder mobility), calcification size <5 mm, type III and IV calcification according to Chiou HJ et al., duration symptoms less than 2 months, rotator cuff tendon rupture, adhesive capsulitis, application of corticosteroids in the examined shoulder in the previous 3 months, glucocorticoid therapy, physical shoulder therapy in the previous 6 months, shock wave therapy in the previous 12 months, prior percutaneous calcification irrigation, current cervical or cervicobrachial pain syndrome, inflammatory rheumatic disease, scapular dyskinesia with positive assisted and repository scapular test, subacromial/subdeltoid bursitis, recent trauma or malignancy in malignant disease.
During the study, respondents will be able to relieve pain with paracetamol and/or tramadol. Respondents will keep a diary of analgesia, and nonsteroidal anti-inflammatory drugs (NSAIDs) and cryo massage will not be allowed due to their anti-inflammatory effect.
The investigators will record age, sex, dominant arm, height, body weight, body mass index, cigarette smoking, medications, physical activity (sports), and profession. Clinical examination will be performed on the first day and the last day of the therapy.
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)
盲法说明
Randomization of patients will be performed before the intervention in the R software package and the results of the randomization will be known only to the therapist who will be involved in the treatment.
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
- •symptomatic RCT (VAS pain ≥ 4 + limited shoulder mobility) with D-ultrasound calcification size ≥ 5 mm
- •calcification type I and II according to Chiou HJ et al.
- •disease duration ≥ 2 months
排除标准
- •asymptomatic RCT or RCT with mild symptoms (VAS pain ≤ 3 + normal shoulder mobility)
- •calcification size < 5 mm, type III and IV calcification according to Chiou HJ et al.
- •duration symptoms less than 2 months
- •rotator cuff tendon rupture
- •adhesive capsulitis
- •application of corticosteroids in the examined shoulder in the previous 3 months
- •glucocorticoid therapy
- •physical shoulder therapy in the previous 6 months
- •shock wave therapy in the previous 12 months
- •prior percutaneous calcification irrigation
- •current cervical or cervicobrachial pain syndrome
- •inflammatory rheumatic disease
- •scapular dyskinesia with positive assisted and repository scapular test
- •subacromial/subdeltoid bursitis
- •recent trauma or malignancy
结局指标
主要结局
The change in calcification size measured by D-ultrasound before and after the intervention.
时间窗: 4 weeks
The researcher will perform an ultrasound examination of the shoulder immediately before and immediately after the therapeutic intervention. The size of the calcification will be measured according to the standard size measurement protocol, and another examiner will make an independent measurement. The final measure will take the average value of the two.
次要结局
- To compare the effectiveness of therapeutic ultrasound in combination with individual medical gymnastics with the effectiveness of individual medical gymnastics on improving the functional status of the shoulder.(4 weeks)
- To compare the effectiveness of therapeutic ultrasound in combination with individual medical gymnastics with the effectiveness of individual medical gymnastics on the overall satisfaction with the outcome of rehabilitation.(4 weeks)
- To compare the effectiveness of therapeutic ultrasound in combination with individual medical gymnastics with the effectiveness of individual medical gymnastics in reducing pain.(4 weeks)
- To compare the effectiveness of therapeutic ultrasound in combination with individual medical gymnastics with the effectiveness of individual medical gymnastics on increasing shoulder mobility.(4 weeks)
研究者
Stjepan Čota
Stjepan Čota, MD
Clinical Hospital Centre Zagreb