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

Primary Purpose

Chronic Nonspecific Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Electrotherapy
Pilates
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Nonspecific Low Back Pain focused on measuring Pilates-based exercises, Electrotherapy, Interferencial current

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Physical Therapy Outpatient Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electrotherapy

Pilates

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Disability
Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire
Pressure pain threshold
Pressure pain threshold will be evaluated using a pressure algometer
Pain intensity
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

Secondary Outcome Measures

Pain intensity
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Disability
Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire
Global impression of recovery
Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale
Specific disability
Specific disability will be evaluated by an 11-point Patient-specific Functional Scale
Kinesiophobia
Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia

Full Information

First Posted
August 7, 2013
Last Updated
June 15, 2015
Sponsor
Universidade Cidade de Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01919268
Brief Title
Addition of the Interferential Current to the Pilates Method in the Treatment of Chronic Nonspecific Low Back Pain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Nonspecific Low Back Pain
Keywords
Pilates-based exercises, Electrotherapy, Interferencial current

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrotherapy
Arm Type
Experimental
Arm Description
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).
Arm Title
Pilates
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Electrotherapy
Intervention Description
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
Intervention Name(s)
Pilates
Intervention Description
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).
Primary Outcome Measure Information:
Title
Disability
Description
Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire
Time Frame
Six weeks after randomization
Title
Pressure pain threshold
Description
Pressure pain threshold will be evaluated using a pressure algometer
Time Frame
Six weeks after randomization
Title
Pain intensity
Description
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Time Frame
Six weeks after randomization
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Time Frame
Six months after randomization
Title
Disability
Description
Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire
Time Frame
Six months after randomization
Title
Global impression of recovery
Description
Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale
Time Frame
Six weeks and six months after randomization
Title
Specific disability
Description
Specific disability will be evaluated by an 11-point Patient-specific Functional Scale
Time Frame
Six weeks and six months after randomization
Title
Kinesiophobia
Description
Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia
Time Frame
Six weeks and six months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Physical Therapy Outpatient Department
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
03071000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27771359
Citation
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.
Results Reference
derived
PubMed Identifier
25492853
Citation
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.
Results Reference
derived

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

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