Low Back Pain Clinical Trial
Official title:
Mechanosensitivity, Morphological, Functional and Contractility Changes by the Capacitive Diathermy in Subjects With Lumbopelvic Pain: a Pilot Study, Single Blind, Randomized Controlled Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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