Capacitive Diathermy in the Lumbopelvic Pain (T-Care)

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Device: Capacitive diathermy (T-CaRe®); Other: Instrumental manual therapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Villaviciosa de Odón, Madrid, Spain, 28670
      • Recruiting
      • European University of Madrid
      • Contact: César Calvo Lobo, PhD, MSc, PT; Phone Number: 5268 0034-912-115-268; Email: cesar.calvo@universidadeuropea.es
      • Principal Investigator: César Calvo Lobo, PhD, MSc, PT
      • Principal Investigator: David Rodríguez Sanz, PhD, MSc, PT
      • Sub-Investigator: Beatriz Martínez Pascual, PhD, MSc, PT
      • Sub-Investigator: Silvia Fernández Martínez, PhD, MSc, PT
      • Sub-Investigator: Mónica de la Cueva Reguera, PhD, MSc, PT
      • Sub-Investigator: Ignacio Diez Vega, PhD, MSc, PT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Age in years.	1 day
Sex (men / women)	1 day
height in meters	1 day
weight in kilograms	1 day
body mass index in kg/m^2	1 day
Borg physical scale from 0 to 10	1 day
Nijmegen distress respiratory test from 0 to 64	1 day

Collaborators and Investigators

• Sponsor: European University of Madrid
• Investigators: Principal Investigator: César Calvo Lobo, PhD, MSc, PT, European University of Madrid; Principal Investigator: David Rodríguez Sanz, PhD, MSc, PT, European University of Madrid

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Estimate): October 7, 2016
• Last Update Submitted That Met QC Criteria: October 6, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CIPI/054/15