PEMFS in Patients With CRPS-I of the Foot and Ankle: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Number of participants with hyperalgesia
研究概览
简要总结
The investigators hypothesize that the association of I-ONE® therapy with standard rehabilitation treatment can optimize the clinical and functional recovery of patients with pulsed electromagnetic fields (PEMFs) (I-ONE® therapy) of the foot or ankle.
详细描述
Study design; spontaneous, prospective, randomized study with control group.
Purpose of the study:
evaluate the functional clinical improvement of the foot/ankle joint with algodystrophic pathology following a standard rehabilitation treatment and home biophysical treatment and local biophysical stimulation with I-ONE® therapy (IGEA SpA).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type I CRPS according to the Budapest criteria (table 1)
- •Type I CRPS involving the ankle or foot
- •Onset of CRPS type I up to a maximum of 3 years after the symptomatic event
- •Pain on visual analog scale (VAS) scale quantified as intensity at least ≥ 5 at recruitment
- •Pharmacological treatment with first infusion cycle of neridronate
排除标准
- •Neurological pathologies (stroke, degenerative, traumatic pathologies)
- •Local neurological impairment (type II CRPS), confirmed by a conduction test or similar
- •Cardiac pacemaker, treatment site malignancy
研究组 & 干预措施
Exercise group
The group, not subjected to biophysical therapy, will be controls. Patients will follow standard rehabilitation treatment: patients will perform active and active-assisted ROM recovery exercises and stretching exercises for 30 minutes per day, for 6 weeks.
I-ONE group
The group will undergo home biophysical treatment with I-ONE® therapy (experimental group) for 4 hours/day for 60 days. Patients will follow standard rehabilitation treatment: patients will perform active and active-assisted range of motion (ROM) recovery exercises and stretching exercises for 30 minutes per day, for 6 weeks.
干预措施: I-One (Device)
结局指标
主要结局
Number of participants with hyperalgesia
时间窗: Change from baseline at 12 months
Clinical evaluation of hyperalgesia (defined as a pin prick-evoked stimulus perceived as something more painful or longer than the duration of the stimulus in the affected limb compared to the contralateral limb: dichotomic present/absent response)
Pain at movement
时间窗: Change from baseline at 12 months
Pain evoked by passive movement (ankle and toe joints for foot involvement) was rated as 0=none, 1=mild, 2=moderate, 3=severe, by direct comparison with the healthy contralateral limb)
Pain intensity
时间窗: at 12 months
Visual Analogue Scale (VAS): the Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Number of participants with allodynia
时间窗: Change from baseline at 12 months
• Clinical assessment of allodynia (tested as pain by lightly stroking with a small brush (end of a cotton swab: dichotomic present/absent response)
Rate of edema
时间窗: Change from baseline at 12 months
• Local edema (score 0=none, 1=mild, 2=moderate, 3=severe, at the level of the ankle and midfoot, by direct comparison with the healthy contralateral limb)
次要结局
- Self-reporting measure of pain(Change from baseline at 12 months)
- Evaluate a better recovery of joint functionality(Change from baseline at 12 months)
- Number of participants taking medications(Change from baseline at 12 months)
- patient assessment of pain and limitations of activity(Change from baseline at 12 months)