Short-term Efficacy of Interferential Current Electro-massage on Self-perceived Pain and Function in Subjects With Subacromial Pain Syndrome: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Pain level, assessed by Visual Analogue Scale
研究概览
简要总结
Objectives: Establishing and validating an electrotherapy procedure with interferential current (IFC) application using electro-massage on patients who have undergone acromioplasty surgery. To evaluate the possible decrease in pain perception and improvement of functionality following surgical intervention.
Design: Randomized, single blind clinical trial. Subjects: 18-patients, aged 18 to 65, with a similar distribution of male and female participants Methods: 10-patients will be enrolled in the experimental group and 8 patients as the control group. Both groups of patients will undergo six physiotherapy sessions (three times a week). The experimental group will undergo a treatment consisting of electro-massage with constant voltage (CV) IFC bipolar application, 4000 Hz carrier current and 100 Hz amplitude modulated frequency (AMF). Two 48 cm2 electrodes will be used. Session length with electrotherapy will be approximately ten minutes.
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
- Single (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
- 否
入选标准
- •patients having undergone acromioplasty surgery in the three months prior to the first day of Physiotherapy treatment
排除标准
- •Value equal to or less than 45 in Personal Psychological Apprehension Scale, showing any absolute contraindication for Physiotherapy or Electrotherapy treatment, fear or apprehension for Electrotherapy application, not signing informed consent, showing alterations in local level sensitivity (cervical-scapulohumeral complex), showing bone fracture associated with SCS, having been applied local infiltration with corticoids following surgery and having started Physiotherapy treatment before signing informed consent.
研究组 & 干预措施
Electromassage
Electromassage and conservatory treatment. All subjects will be received a conservatory treatment (1h and 40 min) and electro-massage (10min).
The protocol will consist of six sessions, twice a week for three weeks. The duration will be 1 hour and 40 min for the conservatory treatment and 10 min for the electro-massage.
干预措施: Electromassage (Other)
Conservatory Treatment
The control protocol will combine: (a) thermotherapy with infrared application; (b) active, self-assisted and isometric shoulder exercises, including Codman's pendulum exercises; (c) manual therapy, always in a pain-free range of movement; and (d) ultrasound in pulsatile mode over the acromium and scapulohumeral area.
干预措施: Conservatory treatment (Other)
结局指标
主要结局
Pain level, assessed by Visual Analogue Scale
时间窗: Change from Baseline Pain level at 3 weeks
This scale is the most accepted to calculate pain level. The range is from 0 (no pain) to 10 (hard pain).
次要结局
- Functional evaluation, assessed by Constant Scale. Reference: Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4(Change from Baseline Constant Scale at 3 weeks)
研究者
Alberto Marcos Heredia-Rizo
Assistant Professor
University of Seville