Addition of the Interferential Current to the Pilates Method in the Treatment of Chronic Nonspecific Low Back Pain

Effectiveness of the Addition of the Interferential Current to the Pilates Method in the Treatment of Patients With Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial

This study aims to evaluate the effectiveness of the addition of the interferential current to Pilates method exercises in the treatment of 148 patients with chronic nonspecific low back pain.

Study Overview

• Status: Completed
• Conditions: Chronic Nonspecific Low Back Pain
• Intervention / Treatment: Device: Electrotherapy; Device: Pilates

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 03071000
      • Physical Therapy Outpatient Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Sedentary patients with chronic nonspecific low back pain longer than 12 weeks
• Pain greater than three points in Pain Numerical Rating Scale

Exclusion Criteria:

• Contra indications to physical exercise
• Serious spinal pathologies (e.g. tumors, fractures and inflammatory diseases)
• Nerve root compromise
• Pregnancy
• Infection and/or skin lesions at the site of the application of the interferential current
• Cancer
• Cardiac pacemaker
• Changes in sensitivity or allergy in the region of electrode placement
• Previous surgery on spine or physical therapy for chronic nonspecific low back pain in the last six months
• Previous experience with the Pilates method

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrotherapy; Combination of active interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient's needs (pragmatic treatment).	Device: Electrotherapy; Combination of active interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of Pilates method will be individualized to each patient's needs (pragmatic treatment).
Active Comparator: Pilates; Combination of placebo interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of six weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient's needs (pragmatic treatment).	Device: Pilates; Combination of placebo interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient's needs (pragmatic treatment).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity will be measured by an 11-point Pain Numerical Rating Scale	Six weeks after randomization
Disability	Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire	Six weeks after randomization
Pressure pain threshold	Pressure pain threshold will be evaluated using a pressure algometer	Six weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity will be measured by an 11-point Pain Numerical Rating Scale	Six months after randomization
Disability	Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire	Six months after randomization
Global impression of recovery	Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale	Six weeks and six months after randomization
Specific disability	Specific disability will be evaluated by an 11-point Patient-specific Functional Scale	Six weeks and six months after randomization
Kinesiophobia	Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia	Six weeks and six months after randomization

Collaborators and Investigators

• Sponsor: Universidade Cidade de Sao Paulo

Publications and helpful links

General Publications

• Franco KM, Franco YD, Oliveira NB, Miyamoto GC, Santos MO, Liebano RE, Cabral CN. Is Interferential Current Before Pilates Exercises More Effective Than Placebo in Patients With Chronic Nonspecific Low Back Pain?: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Feb;98(2):320-328. doi: 10.1016/j.apmr.2016.08.485. Epub 2016 Oct 19.
• Franco YR, Liebano RE, Moura KF, de Oliveira NT, Miyamoto GC, Santos MO, Cabral CM. Efficacy of the addition of interferential current to Pilates method in patients with low back pain: a protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Dec 10;15:420. doi: 10.1186/1471-2474-15-420.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: August 7, 2013
• First Posted (Estimate): August 8, 2013

Study Record Updates

• Last Update Posted (Estimate): June 16, 2015
• Last Update Submitted That Met QC Criteria: June 15, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Electrotherapy; Pilates-based exercises; Interferencial current
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CAAE 18034113.7.0000.0064