NCT01919268

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

1.3 years

First QC Date

August 7, 2013

Last Update Submit

June 15, 2015

Conditions

Chronic Nonspecific Low Back Pain

Keywords

Pilates-based exercisesElectrotherapyInterferencial current

Outcome Measures

Primary Outcomes (3)

  • 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

  • Pain intensity

    Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

    Six weeks after randomization

Secondary Outcomes (5)

  • Pain intensity

    Six months after randomization

  • Disability

    Six months after randomization

  • Global impression of recovery

    Six weeks and six months after randomization

  • Specific disability

    Six weeks and six months after randomization

  • Kinesiophobia

    Six weeks and six months after randomization

Study Arms (2)

Electrotherapy

EXPERIMENTAL

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

Pilates

ACTIVE COMPARATOR

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

Interventions

ElectrotherapyDEVICE

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).

Electrotherapy
PilatesDEVICE

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).

Pilates

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy Outpatient Department

São Paulo, São Paulo, 03071000, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 27771359DERIVED

  • 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.

    PMID: 25492853DERIVED

MeSH Terms

Interventions

Electric Stimulation TherapyExercise Movement Techniques

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

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
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 7, 2013

First Posted

August 8, 2013

Study Start

October 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations

BR(1)