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Capacitive Diathermy in the Lumbopelvic Pain (T-Care)

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ClinicalTrials.gov Identifier: NCT02736201
Recruitment Status : Unknown
Verified October 2016 by European University of Madrid.
Recruitment status was:  Recruiting
First Posted : April 13, 2016
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
European University of Madrid

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Device: Capacitive diathermy (T-CaRe®) Other: Instrumental manual therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

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)




Primary Outcome Measures :
  1. Pain intensity from 0 to 10 [ Time Frame: 4 weeks ]
    Visual analogue scale


Secondary Outcome Measures :
  1. Pressure pain threshold in kg/cm^2 [ Time Frame: 4 weeks ]
    Analogue pressure algometer (Mechanical algometer)

  2. Contractility time in seconds [ Time Frame: 4 weeks ]
    Electrical stimulator

  3. Stiffness by the mean strain ratio (proportion) by Sonoelastography [ Time Frame: 4 weeks ]
    The mean strain ratio by Sonoelastography

  4. Adverse effects (yes or no) [ Time Frame: 4 weeks ]
  5. Oswestry test from 0 to 100 [ Time Frame: 4 weeks ]
  6. Schöber test in centimeters [ Time Frame: 4 weeks ]
  7. Cross sectional area (cm^2) in centimeters [ Time Frame: 4 weeks ]
    Ultrasound imaging (cm^2) in the L4 multifidus of the low back region and the rectus anterior of the abdominal wall. Diagnostic ultrasound system.

  8. Thickness in centimeters [ Time Frame: 4 weeks ]
    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


Other Outcome Measures:
  1. Age in years. [ Time Frame: 1 day ]
  2. Sex (men / women) [ Time Frame: 1 day ]
  3. height in meters [ Time Frame: 1 day ]
  4. weight in kilograms [ Time Frame: 1 day ]
  5. body mass index in kg/m^2 [ Time Frame: 1 day ]
  6. Borg physical scale from 0 to 10 [ Time Frame: 1 day ]
  7. Nijmegen distress respiratory test from 0 to 64 [ Time Frame: 1 day ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736201


Contacts
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Contact: Cesar Calvo Lobo, PhD, MSc, PT 0034-912-115-268 ext 5268 cesar.calvo@universidadeuropea.es

Locations
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Spain
European University of Madrid Recruiting
Villaviciosa de Odón, Madrid, Spain, 28670
Contact: César Calvo Lobo, PhD, MSc, PT    0034-912-115-268 ext 5268    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         
Sponsors and Collaborators
European University of Madrid
Investigators
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Principal Investigator: César Calvo Lobo, PhD, MSc, PT European University of Madrid
Principal Investigator: David Rodríguez Sanz, PhD, MSc, PT European University of Madrid

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Responsible Party: European University of Madrid
ClinicalTrials.gov Identifier: NCT02736201     History of Changes
Other Study ID Numbers: CIPI/054/15
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms