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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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ClinicalTrials.gov Identifier: NCT01919268
Recruitment Status : Completed
First Posted : August 8, 2013
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
Cristina Maria Nunes Cabral, Universidade Cidade de Sao Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Nonspecific Low Back Pain Device: Electrotherapy Device: Pilates Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Disability [ Time Frame: Six weeks after randomization ]
    Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire

  2. Pressure pain threshold [ Time Frame: Six weeks after randomization ]
    Pressure pain threshold will be evaluated using a pressure algometer

  3. Pain intensity [ Time Frame: Six weeks after randomization ]
    Pain intensity will be measured by an 11-point Pain Numerical Rating Scale


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: Six months after randomization ]
    Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

  2. Disability [ Time Frame: Six months after randomization ]
    Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire

  3. Global impression of recovery [ Time Frame: Six weeks and six months after randomization ]
    Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale

  4. Specific disability [ Time Frame: Six weeks and six months after randomization ]
    Specific disability will be evaluated by an 11-point Patient-specific Functional Scale

  5. Kinesiophobia [ Time Frame: Six weeks and six months after randomization ]
    Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919268


Locations
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Brazil
Physical Therapy Outpatient Department
Sao Paulo, SP, Brazil, 03071000
Sponsors and Collaborators
Universidade Cidade de Sao Paulo
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cristina Maria Nunes Cabral, Associate Professor, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT01919268    
Other Study ID Numbers: CAAE 18034113.7.0000.0064
First Posted: August 8, 2013    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015
Keywords provided by Cristina Maria Nunes Cabral, Universidade Cidade de Sao Paulo:
Pilates-based exercises
Electrotherapy
Interferencial current
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations