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

NCT ID: NCT02241538

Last Updated: 2017-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-06-30

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Pilates 1

Intervention Type: 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).

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).

Group Type: EXPERIMENTAL

Pilates 2

Intervention Type: 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

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).

Group Type: EXPERIMENTAL

Pilates 3

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: 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.

Interventions

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).

Intervention Type: DEVICE

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).

Intervention Type: DEVICE

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).

Intervention Type: DEVICE

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 did not receive additional exercise.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Cidade de Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Cristina Maria Nunes Cabral

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Physical Therapy Outpatient Department

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 31153789 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29525763 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26294680 (View on PubMed)

Other Identifiers

29303014.7.0000.0064

Identifier Type: -

Identifier Source: org_study_id