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

Chronic Nonspecific Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919268
• Other study ID #: CAAE 18034113.7.0000.0064
• Status: Completed
• Phase: N/A
• First received: August 7, 2013
• Last updated: June 15, 2015
• Start date: October 2013
• Est. completion date: February 2015

Study information

• Verified date: June 2015
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Nonspecific Low Back Pain
• Low Back Pain

Intervention

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).
• 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).

Locations

Country	Name	City	State
Brazil	Physical Therapy Outpatient Department	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability	Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire	Six weeks after randomization	No
Primary	Pressure pain threshold	Pressure pain threshold will be evaluated using a pressure algometer	Six weeks after randomization	No
Primary	Pain intensity	Pain intensity will be measured by an 11-point Pain Numerical Rating Scale	Six weeks after randomization	No
Secondary	Pain intensity	Pain intensity will be measured by an 11-point Pain Numerical Rating Scale	Six months after randomization	No
Secondary	Disability	Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire	Six months after randomization	No
Secondary	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	No
Secondary	Specific disability	Specific disability will be evaluated by an 11-point Patient-specific Functional Scale	Six weeks and six months after randomization	No
Secondary	Kinesiophobia	Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia	Six weeks and six months after randomization	No