Capacitive Diathermy in the Lumbopelvic Pain

Low Back Pain Clinical Trial

— T-Care  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02736201
• Other study ID #: CIPI/054/15
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2016
• Last updated: October 6, 2016
• Start date: May 2016
• Est. completion date: March 2017

Study information

• Verified date: October 2016
• Source: European University of Madrid
• Contact: Cesar Calvo Lobo, PhD, MSc, PT
• Phone: 0034-912-115-268
• Email: cesar.calvo[@]universidadeuropea.es
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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)

Locations

Country	Name	City	State
Spain	European University of Madrid	Villaviciosa de Odón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
European University of Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age in years.		1 day	Yes
Other	Sex (men / women)		1 day	Yes
Other	height in meters		1 day	Yes
Other	weight in kilograms		1 day	Yes
Other	body mass index in kg/m^2		1 day	Yes
Other	Borg physical scale from 0 to 10		1 day	Yes
Other	Nijmegen distress respiratory test from 0 to 64		1 day	Yes
Primary	Pain intensity from 0 to 10	Visual analogue scale	4 weeks	Yes
Secondary	Pressure pain threshold in kg/cm^2	Analogue pressure algometer (Mechanical algometer)	4 weeks	Yes
Secondary	Contractility time in seconds	Electrical stimulator	4 weeks	Yes
Secondary	Stiffness by the mean strain ratio (proportion) by Sonoelastography	The mean strain ratio by Sonoelastography	4 weeks	Yes
Secondary	Adverse effects (yes or no)		4 weeks	Yes
Secondary	Oswestry test from 0 to 100		4 weeks	Yes
Secondary	Schöber test in centimeters		4 weeks	Yes
Secondary	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	Yes
Secondary	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	Yes