Comparison of Manual Therapy Versus Low-medium Energy Radial Shock Waves in the Treatment of Subacromial Syndrome in a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Shoulder Pain
研究概览
简要总结
Subacromial syndrome represents the third leading cause of pain in the general population. There is no clear pathophysiological explanation, nor a specific treatment. Manual therapy stands out as one of the reference treatments for this disease, however, it is complex to develop a specific protocol. On the other hand, shock waves have still not received adequate attention in the treatment of this pathology. The aim of this study will focus on using manual treatment using ischemic pressure, joint mobilizations and myofascial techniques in comparison to shock wave therapy to determine which is more effective.
This study will be a randomized, single-blind clinical trial with third-party evaluation. In it 88 subjects suffering from subacromial syndrome will participate. 44 patients will receive treatment through manual therapy over 6 weeks and other 44 patients through low-med energy radial shock waves for 6 weeks.
All subjects will complete their treatment with a 12-week home-based therapeutic exercise program.
The main endpoint of the study will be pain measured using the visual analogue scale (VAS) in motion. Pain will also be assessed using the VAS scale at rest and overnight. The Spadi Spanish version questionnaire will be used, shoulder strength will be measured using a handheld dynamometer and the ranges of motion will be measured.
Data will be measured before and one year after treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral shoulder pain with no history of trauma.
- •Pain of at least 4/10 on the Visual Analogue Scale for a minimum period of 3 months.
- •Be positive in at least 3 of the following 5 tests: painful arc test, Neer impingement test, Hawkins-Kennedy test, Jobe test, external rotation test against resistance for the infraspinatus tendon.
排除标准
- •Presence of red flags.
- •Diagnosis of shoulder instability.
- •Diagnosis of frozen shoulder.
- •Diagnosis of complete rupture of the common rotator cuff tendon.
- •Diagnosis of cervical radiculopathy.
- •Diagnosis of whiplash.
- •Diagnosis of degenerative disease of the glenohumeral joint.
结局指标
主要结局
Shoulder Pain
时间窗: Change from Baseline pain at 12 month.
Pain intensity will be measured using the Visual Analog Scale (VAS) for pain. The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and ten the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.
次要结局
- Disability(Change from Baseline pain at 12 month.)
- Muscle Force(Change from Baseline pain at 12 month.)
- Graded Chronic Pain Scale (CPGS)(Change from Baseline pain at 12 month.)
- Shoulder range of movement (ROM)(Change from Baseline pain at 12 month.)
研究者
Prof. Dr. Daniel Pecos Martín
Professor
University of Alcala