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

Not Applicable

Completed

• Conditions: Chronic Nonspecific Low Back Pain
• Interventions: Device: Pilates; Device: Electrotherapy

• Registration Number: NCT01919268
• Lead Sponsor: Universidade Cidade de Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-07
• Study First Submitted QC: 2013-08-07
• Study First Posted: 2013-08-08
• Study Start: 2013-10
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-15
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pilates	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).
Electrotherapy	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Physical Therapy Outpatient Department; 🇧🇷 Sao Paulo, SP, Brazil