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

NCT ID: NCT01919268

Last Updated: 2015-06-16

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Nonspecific Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Electrotherapy

Intervention Type DEVICE

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).

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).

Group Type ACTIVE_COMPARATOR

Pilates

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Cidade de Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Cristina Maria Nunes Cabral

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Physical Therapy Outpatient Department

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 27771359 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25492853 (View on PubMed)

Other Identifiers

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CAAE 18034113.7.0000.0064

Identifier Type: -

Identifier Source: org_study_id

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