Capacitive Diathermy in the Lumbopelvic Pain (T-Care)
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Capacitive diathermy (T-CaRe®)
Instrumental manual therapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
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
Sites / Locations
- European University of MadridRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
IMT+ T-CaRe®on; n = 10
IMT+ T-CaRe® off; n = 10
Arm Description
The instrumental manual therapy with the switched on capacitive diathermy electrode
The instrumental manual therapy with the switched off capacitive diathermy electrode
Outcomes
Primary Outcome Measures
Pain intensity from 0 to 10
Visual analogue scale
Secondary Outcome Measures
Pressure pain threshold in kg/cm^2
Analogue pressure algometer (Mechanical algometer)
Contractility time in seconds
Electrical stimulator
Stiffness by the mean strain ratio (proportion) by Sonoelastography
The mean strain ratio by Sonoelastography
Adverse effects (yes or no)
Oswestry test from 0 to 100
Schöber test in centimeters
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.
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
Full Information
NCT ID
NCT02736201
First Posted
March 24, 2016
Last Updated
October 6, 2016
Sponsor
European University of Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02736201
Brief Title
Capacitive Diathermy in the Lumbopelvic Pain
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European University of Madrid
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IMT+ T-CaRe®on; n = 10
Arm Type
Experimental
Arm Description
The instrumental manual therapy with the switched on capacitive diathermy electrode
Arm Title
IMT+ T-CaRe® off; n = 10
Arm Type
Sham Comparator
Arm Description
The instrumental manual therapy with the switched off capacitive diathermy electrode
Intervention Type
Device
Intervention Name(s)
Capacitive diathermy (T-CaRe®)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Instrumental manual therapy
Intervention Description
Bilateral longitudinal massage in the lumbar region (110 mm; 5 minutes in each side)
Primary Outcome Measure Information:
Title
Pain intensity from 0 to 10
Description
Visual analogue scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pressure pain threshold in kg/cm^2
Description
Analogue pressure algometer (Mechanical algometer)
Time Frame
4 weeks
Title
Contractility time in seconds
Description
Electrical stimulator
Time Frame
4 weeks
Title
Stiffness by the mean strain ratio (proportion) by Sonoelastography
Description
The mean strain ratio by Sonoelastography
Time Frame
4 weeks
Title
Adverse effects (yes or no)
Time Frame
4 weeks
Title
Oswestry test from 0 to 100
Time Frame
4 weeks
Title
Schöber test in centimeters
Time Frame
4 weeks
Title
Cross sectional area (cm^2) in centimeters
Description
Ultrasound imaging (cm^2) in the L4 multifidus of the low back region and the rectus anterior of the abdominal wall. Diagnostic ultrasound system.
Time Frame
4 weeks
Title
Thickness in centimeters
Description
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
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Age in years.
Time Frame
1 day
Title
Sex (men / women)
Time Frame
1 day
Title
height in meters
Time Frame
1 day
Title
weight in kilograms
Time Frame
1 day
Title
body mass index in kg/m^2
Time Frame
1 day
Title
Borg physical scale from 0 to 10
Time Frame
1 day
Title
Nijmegen distress respiratory test from 0 to 64
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cesar Calvo Lobo, PhD, MSc, PT
Phone
0034-912-115-268
Ext
5268
Email
cesar.calvo@universidadeuropea.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
César Calvo Lobo, PhD, MSc, PT
Organizational Affiliation
European University of Madrid
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Rodríguez Sanz, PhD, MSc, PT
Organizational Affiliation
European University of Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
European University of Madrid
City
Villaviciosa de Odón
State/Province
Madrid
ZIP/Postal Code
28670
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
César Calvo Lobo, PhD, MSc, PT
Phone
0034-912-115-268
Ext
5268
Email
cesar.calvo@universidadeuropea.es
First Name & Middle Initial & Last Name & Degree
César Calvo Lobo, PhD, MSc, PT
First Name & Middle Initial & Last Name & Degree
David Rodríguez Sanz, PhD, MSc, PT
First Name & Middle Initial & Last Name & Degree
Beatriz Martínez Pascual, PhD, MSc, PT
First Name & Middle Initial & Last Name & Degree
Silvia Fernández Martínez, PhD, MSc, PT
First Name & Middle Initial & Last Name & Degree
Mónica de la Cueva Reguera, PhD, MSc, PT
First Name & Middle Initial & Last Name & Degree
Ignacio Diez Vega, PhD, MSc, PT
12. IPD Sharing Statement
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Capacitive Diathermy in the Lumbopelvic Pain
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