Pulsed Electromagnetic Field in Patients With Impingement Shoulder: A Randomized, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rotator cuff muscle force
研究概览
简要总结
In the past many authors have reported the abnormal contact between the rotator cuff and coracoacromial arch, but the exact etiology was not clearly understood. Thus, the objectives of this study relate specifically to improve the symptoms and rehabilitation of shoulder function of the patient:
- Assess the effectiveness of magnet therapy in the treatment of impingement of the rotator cuff;
- Assess whether the application of magnetic therapy 3 times a week for three weeks, may be effective as a single treatment of impingement of the rotator cuff;
- Assess whether the combination of magnetic therapy with therapeutic exercises is more effective than magnetic therapy only;
- Evaluate the benefits of magnetic therapy associated with therapeutic exercise in the short and long term.
- Assess the effectiveness of the modulation of pulsed electromagnetic field at 25 Hz and 20 mT in patients with shoulder impingement syndrome.
详细描述
- Randomization of the patients 1.1) Duration of wash-out Having made the proper screening of patients undergoing the study, all pre-selected patients should discontinue any medications that might influence the symptoms of impingement syndrome (such as analgesics, antiinflammatory, chondroprotective, etc.) for a period of 7 days.
1.2) Randomization
The investigators have chosen a total sample of 30 patients undergoing the study. Only one will be treated the shoulders of patients, if there are cases of bilateral impingement syndrome (IS). Patients will be equally distributed in two groups, receiving first place:
Group 1: treatment with magnetic therapy, three times per week lasting 30 minutes each session.
Group 2: placebo of magnet therapy (MT), three times per week lasting 30 minutes each session.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient must have a diagnosis of impingement of the rotator cuff grade II or grade III. For patients with grade III, they must present at least 90 ° of active elevation of the affected shoulder-free. Patients with extensive lesions of the rotator cuff will be deleted.
- •The patient must be aged between 30 and 50 years, of both sexes.
- •Patients should not use any anti-inflammatory, analgesic and / or chondroprotective by at least one week before the start of treatment.
- •The patient must not have been subjected to intra-articular injection of corticosteroids for at least 30 days before the start of treatment.
- •The patient can not be being subjected to physical therapy for at least 30 days before the start of treatment.
- •Patient must have at least 3 months of discomfort and / or symptoms of impingement syndrome.
排除标准
- •Make use of systemic anti-inflammatory medications and / or topics during the study.
- •Patient presenting during pregnancy or postpartum.
- •A patient with cancer, even if you are treated.
- •Having been subjected to surgery on the shoulder to receive the study treatment
- •submit inflammatory joint diseases (such as rheumatoid arthritis, lupus, gout, etc.) except for the impingement of the rotator cuff.
- •Patients who do not submit high active-free up to 90 degrees (minimum) of the affected shoulder will be deleted. These cases are specific to patients with extensive lesions of the rotator cuff and have no function of this muscle group.
研究组 & 干预措施
Placebo
干预措施: Pulsed Electromagnetical Field and Exercise (Other)
Pulsed Electromagnetical Field
干预措施: Pulsed Electromagnetical Field and Exercise (Other)
结局指标
主要结局
Rotator cuff muscle force
时间窗: 3 weeks after exercise
Patients selected are those referred with a diagnosis of impingement syndrome grade II and III. All will be evaluated by a blinded investigator, who uses measurement of rotator cuff muscle force after 3 weeks of exercise treatment.
次要结局
- Rotator cuff muscle force(3 months post-exercise follow up)
研究者
Diego Galace de Freitas
MSc Student Diego Freitas
Faculdade de Ciências Médicas da Santa Casa de São Paulo