Effectiveness of Different Weekly Frequency of Modified Pilates Method Exercises in the Treatment of Chronic Nonspecific Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Device: Pilates 3; Device: Pilates 1; Device: Pilates 2; Device: Control

• Registration Number: NCT02241538
• Lead Sponsor: Universidade Cidade de Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-16
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-05
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pilates 3	Pilates 3	Combination of an educational booklet 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).
Pilates 1	Pilates 1	Combination of an educational booklet with exercises of the Pilates method. Patients will receive 6 sessions of treatment over a period of 6 weeks (1 session/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).
Pilates 2	Pilates 2	Combination of an educational booklet with exercises of the Pilates method. Patients will receive 12 sessions of treatment over a period of 6 weeks (2 sessions/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).
Control	Control	Patients will receive an educational booklet containing information about the anatomy of the spine and pelvis and the low back pain and recommendations regarding posture and movements involved in activities of daily living. The participants in this group will not receive additional exercise.

Primary Outcome Measures

Name	Time	Method
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 Roland Morris Disability Questionaire

Secondary Outcome Measures

Name	Time	Method
Disability	Six and twelve months after randomization	Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire
Global impression of recovery	Six weeks, six and twelve months after randomization	Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale
Cost Effectiveness	Six weeks, six and twelve months after randomization	Assessments of direct costs (patient out-of-pocket costs) by an specific questionnaire.
Quality Adjusted Life Years	Six weeks, six and twelve months after randomization	Quality adjusted life years will be measured by the SF-6D questionnaire
Pain intensity	Six and twelve months after randomization	Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Specific disability	Six weeks, six and twelve months after randomizaion	Specific disability will be evaluated by an 11-point Patient-specific Functional Scale
Kinesiophobia	Six weeks, six and twelve months after randomization	Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia
Pain-Related Catastrophizing	Six weeks, six and twelve months after randomization	Pain-related catastrophizing will be evaluated by the Pain-Related Catastrophizing Thoughts Scale

Trial Locations

Locations (1)

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