Capacitive Diathermy in the Lumbopelvic Pain
- Conditions
- Low Back Pain
- Interventions
- Device: Capacitive diathermy (T-CaRe®)Other: Instrumental manual therapy
- Registration Number
- NCT02736201
- Lead Sponsor
- European University of Madrid
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- bilateral lumbopelvic pain for 6 weeks
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IMT+ T-CaRe®on; n = 10 Instrumental manual therapy The instrumental manual therapy with the switched on capacitive diathermy electrode IMT+ T-CaRe® off; n = 10 Capacitive diathermy (T-CaRe®) The instrumental manual therapy with the switched off capacitive diathermy electrode IMT+ T-CaRe® off; n = 10 Instrumental manual therapy The instrumental manual therapy with the switched off capacitive diathermy electrode IMT+ T-CaRe®on; n = 10 Capacitive diathermy (T-CaRe®) The instrumental manual therapy with the switched on capacitive diathermy electrode
- Primary Outcome Measures
Name Time Method Pain intensity from 0 to 10 4 weeks Visual analogue scale
- Secondary Outcome Measures
Name Time Method Stiffness by the mean strain ratio (proportion) by Sonoelastography 4 weeks The mean strain ratio by Sonoelastography
Thickness in centimeters 4 weeks 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
Adverse effects (yes or no) 4 weeks Oswestry test from 0 to 100 4 weeks Pressure pain threshold in kg/cm^2 4 weeks Analogue pressure algometer (Mechanical algometer)
Contractility time in seconds 4 weeks Electrical stimulator
Schöber test in centimeters 4 weeks Cross sectional area (cm^2) in centimeters 4 weeks Ultrasound imaging (cm\^2) in the L4 multifidus of the low back region and the rectus anterior of the abdominal wall. Diagnostic ultrasound system.
Trial Locations
- Locations (1)
European University of Madrid
🇪🇸Villaviciosa de Odón, Madrid, Spain