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

Study Overview
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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.

Official Title
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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

Conditions
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Chronic Nonspecific Low Back Pain

Intervention / Treatment
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* Device: Electrotherapy
* Device: Pilates


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrotherapy<br>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<br>* 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).<br>|
| Active Comparator: Pilates<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pilates-based exercises, Electrotherapy, Interferencial current