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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Pilates 1
* Device: Pilates 2
* Device: Pilates 3
* Device: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilates 1<br>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). | Device: Pilates 1<br>* 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).<br>|
| Experimental: Pilates 2<br>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). | Device: Pilates 2<br>* 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).<br>|
| Experimental: Pilates 3<br>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). | Device: Pilates 3<br>* 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).<br>|
| Active Comparator: Control<br>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. | Device: Control<br>* 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 did not receive additional exercise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity will be measured by an 11-point Pain Numerical Rating Scale | Six weeks after randomization | 
| Disability | Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire | Six weeks after randomization | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pilates-based exercises