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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
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.
Bilateral longitudinal massage in the lumbar region (110 mm; 5 minutes in each side)
European University of Madrid
Villaviciosa de Odón, Madrid, Spain
RECRUITINGPain intensity from 0 to 10
Visual analogue scale
Time frame: 4 weeks
Pressure pain threshold in kg/cm^2
Analogue pressure algometer (Mechanical algometer)
Time frame: 4 weeks
Contractility time in seconds
Electrical stimulator
Time frame: 4 weeks
Stiffness by the mean strain ratio (proportion) by Sonoelastography
The mean strain ratio by Sonoelastography
Time frame: 4 weeks
Adverse effects (yes or no)
Time frame: 4 weeks
Oswestry test from 0 to 100
Time frame: 4 weeks
Schöber test in centimeters
Time frame: 4 weeks
Cross sectional area (cm^2) in centimeters
Ultrasound imaging (cm\^2) in the L4 multifidus of the low back region and the rectus anterior of the abdominal wall. Diagnostic ultrasound system.
Time frame: 4 weeks
Thickness in centimeters
Ultrasound imaging (cm) in the skin, subcutaneous tissue, connective tissue, L4 multifidus and the abdominal Wall (rectus anterior, external oblique, internus oblique and transversus abdominis). Diagnostic ultrasound system
Time frame: 4 weeks
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