Clinical trial NCT02736201: Capacitive Diathermy in the Lumbopelvic Pain
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: European University of Madrid
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity from 0 to 10
timeFrame: 4 weeks
Secondary outcomes:
measure: Pressure pain threshold in kg/cm^2
timeFrame: 4 weeks
measure: Contractility time in seconds
timeFrame: 4 weeks
measure: Stiffness by the mean strain ratio (proportion) by Sonoelastography
timeFrame: 4 weeks
measure: Adverse effects (yes or no)
timeFrame: 4 weeks
measure: Oswestry test from 0 to 100
timeFrame: 4 weeks
measure: Schöber test in centimeters
timeFrame: 4 weeks
measure: Cross sectional area (cm^2) in centimeters
timeFrame: 4 weeks
measure: Thickness in centimeters
timeFrame: 4 weeks
Other outcomes:
measure: Age in years.
timeFrame: 1 day
measure: Sex (men / women)
timeFrame: 1 day
measure: height in meters
timeFrame: 1 day
measure: weight in kilograms
timeFrame: 1 day
measure: body mass index in kg/m^2
timeFrame: 1 day
measure: Borg physical scale from 0 to 10
timeFrame: 1 day
measure: Nijmegen distress respiratory test from 0 to 64
timeFrame: 1 day
Locations:
city: Villaviciosa de Odón
country: Spain
facility: European University of Madrid
state: Madrid
Study officials:
affiliation: European University of Madrid
name: César Calvo Lobo, PhD, MSc, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: European University of Madrid
name: David Rodríguez Sanz, PhD, MSc, PT
role: PRINCIPAL_INVESTIGATOR
References: