Clinical trial NCT01919268: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Nonspecific Low Back Pain
Keywords: Pilates-based exercises
Electrotherapy
Interferencial current
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2013-08-08
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Disability
timeFrame: Six weeks after randomization
measure: Pressure pain threshold
timeFrame: Six weeks after randomization
measure: Pain intensity
timeFrame: Six weeks after randomization
Secondary outcomes:
measure: Pain intensity
timeFrame: Six months after randomization
measure: Disability
timeFrame: Six months after randomization
measure: Global impression of recovery
timeFrame: Six weeks and six months after randomization
measure: Specific disability
timeFrame: Six weeks and six months after randomization
measure: Kinesiophobia
timeFrame: Six weeks and six months after randomization
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Physical Therapy Outpatient Department
state: SP
Study officials:
References:
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.
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.