Suprascapular Nerve Block Guided by Ultrasound in the Rehabilitation of the Supraspinatus Tendonitis - A Randomized Double Blind Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Change from baseline in the score of pain and function as assessed by Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
The purpose of this study is to evaluate the effect of suprascapular nerve block guided by ultrasound combined with home exercises compared with placebo. Pain intensity, function, pressure pain threshold and goniometry were designed to be assessed in all patients.
详细描述
The trial is being carried out in the Institute of Physical Medicine and Rehabilitation of the University of São Paulo since June 2013. The investigators are including patients with clinical diagnosis of supraspinatus tendinitis based on the Lateral Jobe Test.
The patients are being randomized in two arms: Active (2% 5ml lidocaine for suprascapular nerve block and home exercises) and placebo control (saline solution as the nerve block and home exercises). The randomization is being performed in blocks of 4 and 6.
The investigator, the raters, the MD who makes the procedure and the patients are blind to treatment.
4 visits are being performed. Screening and initial evaluation visit, procedure visit, follow up 1 week after intervention and follow up 12 weeks after intervention.
The sample size was estimated to be 54 in each arm.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of supraspinatus tendonitis, based on Jobe's lateral test;
- •Pain longer than 1 month prior to screening visit;
- •BMI between 20 and 30 kg/m²;
- •VAS of 4 or higher in screening visit;
- •Ability to understand the questionaires and instructions for home exercises;
- •Signed Informed Consent Form;
排除标准
- •History of:
- •Shoulder surgery;
- •Athletic activities;
- •Severe shoulder arthrosis;
- •Diagnosis of total rupture of supraspinatus tendon
- •Autoimmune disease;
- •Fracture of humerus, acromion and clavicle
- •Luxation and subluxation of shoulder.
- •Diseases that cause spasticity, such as stroke or spinal cord injury;
- •Systemic alterations that can lead to peripheral neuropathy;
- •Uncontrolled Diabetes or thyroidopathy;
- •Diagnosis of cervical spinal cord injury that results in motor alterations;
- •Allergy or hypersensibility for local or systemic anaesthetics;
- •Coagulopathy;
- •Fibromyalgia according to the 1990 American School of Rheumatology;
- •Uncontrolled psychiatric diseases or controlled psychiatric diseases that need more than two medicines;
- •Acute of chronic renal failure;
- •Pulmonary diseases that presents hypoxemia such as Gold IV Chronic Obstructive Pulmonary Disease or pulmonary fibrosis.
- •Arrhythmia (except isolated supraventricular extrasystoles), coronary failure or functional class 2 or higher heart failure
- •Pregnancy;
- •Use of oral or subcutaneous anticoagulation agent;
- •Patients who fail to comply with the proposed treatment.
研究组 & 干预措施
Lidocaine
Suprascapular nerve block with infusion of 5ml lidocaine at 2%, guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).
干预措施: Homemade exercises (Other)
Saline solution
Intervention with suprascapular nerve block with 5ml saline solution guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).
干预措施: Saline solution (Procedure)
Saline solution
Intervention with suprascapular nerve block with 5ml saline solution guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).
干预措施: Homemade exercises (Other)
Lidocaine
Suprascapular nerve block with infusion of 5ml lidocaine at 2%, guided by Ultrasound combined with homemade exercises (Codman and Hughston exercises).
干预措施: Lidocaine (Procedure)
结局指标
主要结局
Change from baseline in the score of pain and function as assessed by Shoulder Pain and Disability Index (SPADI)
时间窗: Baseline and one week after intervention
Scale for assessing pain and shoulder function.
次要结局
- Change from baseline in pain Intensity assessed by Visual Analogue Scale (VAS).(Baseline and twelve weeks after intervention.)
- Change from baseline in the score of pain and function as assessed by SPADI(Baseline and 12 weeks after intervention)
- Change from baseline in Pain Pressure Threshold (PPT) as assessed by Algometry(Baseline and twelve weeks after intervention)
- Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry(Baseline and twelve weeks after intervention)
- Safety as assessed by the number of Adverse Events(1 week and 12 weeks after intervention)
研究者
Marta Imamura
Coordinator of the Clinical Research Center for Physical and Rehabilitation Medicine of HC FMUSP
University of Sao Paulo