Mechanosensitivity, Morphological, Functional and Contractility Changes by the Capacitive Diathermy in Subjects With Lumbopelvic Pain: a Pilot Study, Single Blind, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain intensity from 0 to 10
研究概览
简要总结
Objective: To determine the effectiveness of the capacitive diathermy in the mechanosensitivity, morphological, functional and contractility changes in patients with lumbopelvic pain.
Design: A pilot study, single blind, randomized controlled clinical trial, approved previously by The Princess University Hospital Ethics Committee (Feb 11, 2016) and the European University clinical intervention review board (CIPI/054/15).
Setting: Faculty of Health Sciences, Exercise and Sport. European University of Madrid.
Patients and intervention: A sample of 20 patients with bilateral lumbopelvic pain, between 18 and 60 years old, will be recruited and randomized into 2 intervention groups. The instrumental manual therapy with the switched on capacitive diathermy electrode (IMT+ T-CaRe®on; n = 10) and the instrumental manual therapy with the switched off capacitive diathermy electrode (IMT+ T-CaRe®off; n = 10) will be bilaterally treated for 4 weeks (1 treatment per week during 10 minutes) in the lumbopelvic region.
Outcome measurements: Control variables such as the age, sex, height, weight, body mass index, Borg scale physical activity and distress respiratory test will be measured at the beginning of the treatment. Dependent variables such as the pain intensity, the pressure pain threshold, the contractility, the stiffness, the adverse effects, the Oswestry and Schöber test, as well as the ultrasound imaging cross sectional area and thickness of the skin, subcutaneous tissue, connective tissue, L4 multifidus and the abdominal Wall (rectus anterior, externus oblique, internal oblique and transversus abdominis) will be assessed before and after each intervention by a blinded examiner.
Analysis data: The statistical analysis will be performed with a 95% confidence interval and the Statistic Package Social Sciences (SPSS) 22.0.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bilateral lumbopelvic pain for 6 weeks
排除标准
- •neuromuscular conditions
- •negative straight leg raise test
- •respiratory or congenital conditions
- •surgeries
- •neurologic signs
- •lower extremities conditions
- •skin alterations
- •cognitive disorders
- •body mass index higher than 31 kg/cm2
- •skin alterations
- •pregnancy
- •intensive physical activity
- •Nijmegen test higher than 24
研究组 & 干预措施
IMT+ T-CaRe®on; n = 10
The instrumental manual therapy with the switched on capacitive diathermy electrode
干预措施: Capacitive diathermy (T-CaRe®) (Device)
IMT+ T-CaRe®on; n = 10
The instrumental manual therapy with the switched on capacitive diathermy electrode
干预措施: Instrumental manual therapy (Other)
IMT+ T-CaRe® off; n = 10
The instrumental manual therapy with the switched off capacitive diathermy electrode
干预措施: Capacitive diathermy (T-CaRe®) (Device)
IMT+ T-CaRe® off; n = 10
The instrumental manual therapy with the switched off capacitive diathermy electrode
干预措施: Instrumental manual therapy (Other)
结局指标
主要结局
Pain intensity from 0 to 10
时间窗: 4 weeks
Visual analogue scale
次要结局
- Schöber test in centimeters(4 weeks)
- Stiffness by the mean strain ratio (proportion) by Sonoelastography(4 weeks)
- Thickness in centimeters(4 weeks)
- Adverse effects (yes or no)(4 weeks)
- Oswestry test from 0 to 100(4 weeks)
- Pressure pain threshold in kg/cm^2(4 weeks)
- Contractility time in seconds(4 weeks)
- Cross sectional area (cm^2) in centimeters(4 weeks)