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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02241538
• Other study ID #: 29303014.7.0000.0064
• Status: Completed
• Phase: N/A
• First received: September 12, 2014
• Last updated: September 5, 2017
• Start date: September 2014
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• 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).
• 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).
• 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).
• 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.

Locations

Country	Name	City	State
Brazil	Physical Therapy Outpatient Department	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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