Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2016-05-31
2017-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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IMT+ T-CaRe®on; n = 10
The instrumental manual therapy with the switched on capacitive diathermy electrode
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.
Instrumental manual therapy
Bilateral longitudinal massage in the lumbar region (110 mm; 5 minutes in each side)
IMT+ T-CaRe® off; n = 10
The instrumental manual therapy with the switched off capacitive diathermy electrode
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.
Instrumental manual therapy
Bilateral longitudinal massage in the lumbar region (110 mm; 5 minutes in each side)
Interventions
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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.
Instrumental manual therapy
Bilateral longitudinal massage in the lumbar region (110 mm; 5 minutes in each side)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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European University of Madrid
OTHER
Responsible Party
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Principal Investigators
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César Calvo Lobo, PhD, MSc, PT
Role: PRINCIPAL_INVESTIGATOR
European University of Madrid
David Rodríguez Sanz, PhD, MSc, PT
Role: PRINCIPAL_INVESTIGATOR
European University of Madrid
Locations
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European University of Madrid
Villaviciosa de Odón, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIPI/054/15
Identifier Type: -
Identifier Source: org_study_id
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