Clinical trial NCT02241538: Effectiveness of Different Weekly Frequency of Modified Pilates Method Exercises in the Treatment of Chronic Nonspecific Low Back Pain
Official title: Cost Effectiveness and Effectiveness of the Addition of Different Weekly Frequency of Modified Pilates Method Exercises to a Minimal Intervention in the Treatment of Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Pilates-based exercises
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 296
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: Low back pain is a major cause of disability and absenteeism and the supervised exercise is a recommended treatment by the guidelines and has been cost-effective. Currently, the Pilates method has shown to be effective in improving pain and disability in patients with chronic low back pain (CLBP). However, there is still no evidence about the ideal number of sessions for the treatment and the interval between sessions to achieve better efficacy of this method for these patients. Thus, the aim of this study is to investigate the effectiveness of the Pilates method with different weekly frequency of sessions in the treatment of patients with nonspecific CLBP. Investigators will assess 296 patients of both genders, with nonspecific CLBP lasting more than three months and aged between 18 and 80 years. Participants will be randomly divided into four groups (n = 74 patients per group): Control Group will receive an educational booklet and no additional exercise, Pilates 1 Group will receive a program of exercises based on Pilates method once a week for six weeks, Pilates 2 Group will receive the same program of exercises twice a week for six weeks and Pilates 3 Group will receive the same program of exercises three times a week for six weeks. The outcomes overall disability (Roland Morris Disability questionnaire), specific disability (Patient-Specific Functional scale), kinesiophobia (Tampa scale for kinesiophobia), pain intensity (Pain Numerical Rating scale) and global perceived effect (Global Perceived Effect scale) will be assessed by a blinded assessor before, six weeks, six and 12 months after randomization. Investigators expect that the largest number of weekly sessions of Pilates method may influence the results in all analyzes (short, medium and long term), since there is a relationship between frequency of exercises and effect size of the treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic nonspecific low back pain longer 12 weeks

Exclusion Criteria:

* Contra indications to physical exercise
* Serious spinal pathologies (e. g. tumors, fractures and inflammatory diseases)
* Nerve root compromise
* Pregnancy
* Previous surgery on spine
* Pilates treatment for low back pain in the last three months

Primary outcomes:
measure: Pain intensity
timeFrame: Six weeks after randomization
measure: Disability
timeFrame: Six weeks after randomization
Secondary outcomes:
measure: Pain intensity
timeFrame: Six and twelve months after randomization
measure: Disability
timeFrame: Six and twelve months after randomization
measure: Global impression of recovery
timeFrame: Six weeks, six and twelve months after randomization
measure: Specific disability
timeFrame: Six weeks, six and twelve months after randomizaion
measure: Kinesiophobia
timeFrame: Six weeks, six and twelve months after randomization
measure: Pain-Related Catastrophizing
timeFrame: Six weeks, six and twelve months after randomization
measure: Cost Effectiveness
timeFrame: Six weeks, six and twelve months after randomization
measure: Quality Adjusted Life Years
timeFrame: Six weeks, six and twelve months after randomization
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Physical Therapy Outpatient Department
state: SP
Study officials:
References:
citation: Silva MLD, Miyamoto GC, Franco KFM, Franco YRDS, Cabral CMN. Different weekly frequencies of Pilates did not accelerate pain improvement in patients with chronic low back pain. Braz J Phys Ther. 2020 May-Jun;24(3):287-292. doi: 10.1016/j.bjpt.2019.05.001. Epub 2019 May 16.
citation: Miyamoto GC, Franco KFM, van Dongen JM, Franco YRDS, de Oliveira NTB, Amaral DDV, Branco ANC, da Silva ML, van Tulder MW, Cabral CMN. Different doses of Pilates-based exercise therapy for chronic low back pain: a randomised controlled trial with economic evaluation. Br J Sports Med. 2018 Jul;52(13):859-868. doi: 10.1136/bjsports-2017-098825. Epub 2018 Mar 10.
citation: Miyamoto GC, Moura KF, Franco YR, Oliveira NT, Amaral DD, Branco AN, Silva ML, Lin C, Cabral CM. Effectiveness and Cost-Effectiveness of Different Weekly Frequencies of Pilates for Chronic Low Back Pain: Randomized Controlled Trial. Phys Ther. 2016 Mar;96(3):382-9. doi: 10.2522/ptj.20150404. Epub 2015 Aug 20.