Capacitive Diathermy in the Lumbopelvic Pain

Study Overview
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Brief Summary
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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.

Official Title
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Mechanosensitivity, Morphological, Functional and Contractility Changes by the Capacitive Diathermy in Subjects With Lumbopelvic Pain: a Pilot Study, Single Blind, Randomized Controlled Clinical Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Capacitive diathermy (T-CaRe®)
* Other: Instrumental manual therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: bilateral lumbopelvic pain for 6 weeks Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMT+ T-CaRe®on; n = 10<br>The instrumental manual therapy with the switched on capacitive diathermy electrode | Device: Capacitive diathermy (T-CaRe®)<br>* 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.<br>Other: Instrumental manual therapy<br>* Bilateral longitudinal massage in the lumbar region (110 mm; 5 minutes in each side)<br>|
| Sham Comparator: IMT+ T-CaRe® off; n = 10<br>The instrumental manual therapy with the switched off capacitive diathermy electrode | Device: Capacitive diathermy (T-CaRe®)<br>* 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.<br>Other: Instrumental manual therapy<br>* Bilateral longitudinal massage in the lumbar region (110 mm; 5 minutes in each side)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity from 0 to 10 | Visual analogue scale | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure pain threshold in kg/cm^2 | Analogue pressure algometer (Mechanical algometer) | 4 weeks | 
| Contractility time in seconds | Electrical stimulator | 4 weeks | 
| Stiffness by the mean strain ratio (proportion) by Sonoelastography | The mean strain ratio by Sonoelastography | 4 weeks | 
| Adverse effects (yes or no) |  | 4 weeks | 
| Oswestry test from 0 to 100 |  | 4 weeks | 
| Schöber test in centimeters |  | 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. | 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 | 4 weeks |