Capacitive Diathermy in the Lumbopelvic Pain (T-Care)

European University

Status: Unknown

Conditions: Low Back Pain

Treatments: Other: Instrumental manual therapy; Device: Capacitive diathermy (T-CaRe®)

Study type: Interventional

Funder types: Other

Identifiers

NCT02736201

CIPI/054/15

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

IMT+ T-CaRe®on; n = 10

Experimental group

Description:

The instrumental manual therapy with the switched on capacitive diathermy electrode

Treatment:

Other: Instrumental manual therapy

Device: Capacitive diathermy (T-CaRe®)

IMT+ T-CaRe® off; n = 10

Sham Comparator group

Description:

The instrumental manual therapy with the switched off capacitive diathermy electrode

Treatment:

Other: Instrumental manual therapy

Device: Capacitive diathermy (T-CaRe®)