Effects of Therapeutic Ultrasound Combined With Exercise in the Rehabilitation of Individuals Diagnosed With Subacromial Impingement Pain Syndrome: a Randomized, Controlled, Double-blind Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Shoulder pain and disability
研究概览
简要总结
The aim of this study is to analyze the effects of Therapeutic Ultrasound combined with a Therapeutic Exercises program on pain reduction and improvement of function, range of motion (ROM), and functionality in individuals with Subacromial Impingement Syndrome. The main questions it aims to answer are:
Can the application of therapeutic ultrasound combined with exercise reduce pain and improve the ability to perform daily activities (functionality) in patients with Subacromial Impingement Syndrome? Does combining therapeutic ultrasound with exercise improve pain and functionality in patients with Subacromial Impingement Syndrome more effectively than using exercise alone to treat this syndrome? Researchers compared the application of therapeutic ultrasound combined with therapeutic exercises with placebo ultrasound (equipment programmed similarly to active ultrasound but emitting ultrasound waves) plus therapeutic exercises to determine if adding active ultrasound to the treatment is more effective than performing exercises alone in treating patients with Subacromial Impingement Syndrome.
Patients should be evaluated before the start of treatment, eight weeks after the start of treatment, and six months after the end of treatment.
Patients will receive therapeutic ultrasound or placebo combined with exercise 3 times a week for 8 weeks.
详细描述
Introduction
Subacromial impingement syndrome (SIS)/Subacromial pain syndrome (SPS) is among the most common causes of pain and reduced shoulder functionality, characterized by repetitive impingement of structures located in the subacromial space, which anatomically comprises, superiorly, the acromion and inferiorly, the shoulder joint capsule and the subacromial bursa. Management of pathology includes numerous interventions, depending on the intensity of the pain and anatomopathological classification, involving conservative treatment (medications and physiotherapy) or surgical treatment in more severe cases. Objective: To verify the effects of therapeutic ultrasound (TUS), in continuous (USC) and pulsed (USP) modes, associated with a standardized therapeutic exercise (TE) program, on pain, range of motion, and functionality in individuals with shoulder pain associated with subacromial impingement syndrome (SIS). Methods: A randomized, controlled, double-blind clinical trial was conducted with 120 participants of both sexes, aged 30 to 75 years, with a clinical and ultrasound diagnosis compatible with subacromial impingement syndrome/rotator cuff-related shoulder pain. Participants were divided into four groups: (USC+TE), (USP+TE), placebo-controlled TUS associated with exercises (USPPL+TE), and isolated therapeutic exercises (TE)
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, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30 and 75 years.
- •Clinical diagnosis compatible with subacromial pain syndrome.
- •Shoulder pain greater than 30 mm on the Visual Analog Scale.
- •Pain located in the anterolateral region of the shoulder, worsened during elevation of the upper limb.
- •At least three positive clinical tests among the following: Neer impingement sign, Hawkins-Kennedy impingement sign, painful arc between 60° and 120° of abduction, Jobe/empty can test, and resisted external rotation/infraspinatus test.
- •Ultrasonographic confirmation of findings compatible with subacromial pain syndrome.
- •Signed informed consent form.
排除标准
- •Previous surgery on the affected shoulder.
- •Suspected massive rotator cuff tear.
- •Positive drop-arm test.
- •Glenohumeral instability.
- •History of shoulder dislocation or subluxation.
- •Adhesive capsulitis/frozen shoulder.
- •Recent shoulder trauma.
- •Previous shoulder fracture with functional impairment.
- •Cervical radiculopathy with neurological signs.
- •Active inflammatory rheumatologic disease.
- •Uncontrolled hypertension.
- •Neoplasia.
- •Corticosteroid injection within the previous six months.
- •Physical therapy treatment for the shoulder within the previous six months.
- •Continuous use of analgesic or anti-inflammatory medication that could not be discontinued.
- •Contraindications to therapeutic ultrasound.
结局指标
主要结局
Shoulder pain and disability
时间窗: Baseline, Week 12, and Day 240.
Shoulder pain and disability were assessed using the Shoulder Pain and Disability Index (SPADI). The questionnaire consists of 13 items distributed across two domains: pain, with five items, and disability/function, with eight items. Each item is scored from 0 to 10. The total score and domain scores are converted into a percentage scale ranging from 0 to 100, with higher scores indicating worse shoulder pain and disability.
Pain Intensity
时间窗: Baseline, Week 12, and Day 240.
Pain intensity was assessed using the Visual Analog Scale (VAS), separately for pain at rest and pain during activities of daily living (ADLs). The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
次要结局
- Functional shoulder performance(Baseline, Week 12, and Day 240.)
研究者
Raquel A. Casarotto
Associate Professor
University of Sao Paulo General Hospital