Capacitive Diathermy in the Lumbopelvic Pain

NCT02736201 | Unknown DMC

• 1 other identifier: CIPI/054/15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity from 0 to 10

  Visual analogue scale

  4 weeks

Secondary Outcomes (8)

• Pressure pain threshold in kg/cm^2

  4 weeks

• Contractility time in seconds

  4 weeks

• Stiffness by the mean strain ratio (proportion) by Sonoelastography

  4 weeks

• Adverse effects (yes or no)

  4 weeks

• Oswestry test from 0 to 100

  4 weeks

Other Outcomes (7)

• Age in years.

  1 day

• Sex (men / women)

  1 day

• height in meters

  1 day

Study Arms (2)

IMT+ T-CaRe®on; n = 10

EXPERIMENTAL

The instrumental manual therapy with the switched on capacitive diathermy electrode

Device: Capacitive diathermy (T-CaRe®); Other: Instrumental manual therapy

IMT+ T-CaRe® off; n = 10

SHAM COMPARATOR

The instrumental manual therapy with the switched off capacitive diathermy electrode

Device: Capacitive diathermy (T-CaRe®); Other: Instrumental manual therapy

Interventions

Capacitive diathermy (T-CaRe®) DEVICE

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.

IMT+ T-CaRe® off; n = 10; IMT+ T-CaRe®on; n = 10

Instrumental manual therapy OTHER

Bilateral longitudinal massage in the lumbar region (110 mm; 5 minutes in each side)

IMT+ T-CaRe® off; n = 10; IMT+ T-CaRe®on; n = 10

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• bilateral lumbopelvic pain for 6 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• European University of Madrid: lead

Study Sites (1)

European University of Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• César Calvo Lobo, PhD, MSc, PT

  European University of Madrid

  PRINCIPAL INVESTIGATOR

• David Rodríguez Sanz, PhD, MSc, PT

  European University of Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cesar Calvo Lobo, PhD, MSc, PT

CONTACT

0034-912-115-268; cesar.calvo@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 13, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: October 7, 2016

Record last verified: 2016-10

Locations

ES (1)