Low Back Pain
Conditions
Keywords
Pilates-based exercises
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.
Interventions
DEVICEPilates 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).
DEVICEPilates 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).
DEVICEPilates 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).
DEVICEControl
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.
Sponsors
Universidade Cidade de Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 intensity | Six and twelve months after randomization | Pain intensity will be measured by an 11-point Pain Numerical Rating 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-Related Catastrophizing | Six weeks, six and twelve months after randomization | Pain-related catastrophizing will be evaluated by the Pain-Related Catastrophizing Thoughts Scale |
| Disability | Six and twelve months after randomization | Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire |
Countries
Brazil
Outcome results
None listed