Physical Therapy Outpatient Department
São Paulo, 03071000, Brazil
NCT Number: NCT02241538
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
São Paulo, 03071000, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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).
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).
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.
Time frame: Six weeks after randomization
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Time frame: Six weeks after randomization
Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire
Time frame: Six and twelve months after randomization
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Time frame: Six and twelve months after randomization
Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire
Time frame: Six weeks, six and twelve months after randomization
Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale
Time frame: Six weeks, six and twelve months after randomizaion
Specific disability will be evaluated by an 11-point Patient-specific Functional Scale
Time frame: Six weeks, six and twelve months after randomization
Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia
Time frame: Six weeks, six and twelve months after randomization
Pain-related catastrophizing will be evaluated by the Pain-Related Catastrophizing Thoughts Scale
Time frame: Six weeks, six and twelve months after randomization
Assessments of direct costs (patient out-of-pocket costs) by an specific questionnaire.
Time frame: Six weeks, six and twelve months after randomization
Quality adjusted life years will be measured by the SF-6D questionnaire
Universidade Cidade de Sao Paulo
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06840795
Back Pain, Low Back Pain
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06843785
Back Pain, Balance; Distorted
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06837753
Back Pain, Low Back Pain
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06787079
Back Pain, Behavior
Ankara, Turkey (Türkiye)
View Trial Details