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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilates 1 | Experimental | 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 | Experimental | 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). |
|
| Pilates 3 | Experimental | 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). |
|
| Control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilates 1 | Device | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Therapy Outpatient Department | São Paulo | São Paulo | 03071000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31153789 | Derived | 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. | |
| 29525763 | Derived | 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. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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|
| Pilates 2 | Device | 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). |
|
| Pilates 3 | Device | 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). |
|
| Control | Device | 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. |
|
| 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 |
| 26294680 | Derived | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |