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NCT Number: NCT02241538

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Therapy Outpatient Department

São Paulo, 03071000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. Pain intensity

    Time frame: Six weeks after randomization

    Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

  2. Disability

    Time frame: Six weeks after randomization

    Disability associated with low back pain will be measured by the 24-item Roland Morris Disability Questionaire

Secondary outcomes

  1. Pain intensity

    Time frame: Six and twelve months after randomization

    Pain intensity will be measured by an 11-point Pain Numerical Rating Scale

  2. Disability

    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

  3. Global impression of recovery

    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

  4. Specific disability

    Time frame: Six weeks, six and twelve months after randomizaion

    Specific disability will be evaluated by an 11-point Patient-specific Functional Scale

  5. Kinesiophobia

    Time frame: Six weeks, six and twelve months after randomization

    Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia

  6. Pain-Related Catastrophizing

    Time frame: Six weeks, six and twelve months after randomization

    Pain-related catastrophizing will be evaluated by the Pain-Related Catastrophizing Thoughts Scale

  7. Cost Effectiveness

    Time frame: Six weeks, six and twelve months after randomization

    Assessments of direct costs (patient out-of-pocket costs) by an specific questionnaire.

  8. Quality Adjusted Life Years

    Time frame: Six weeks, six and twelve months after randomization

    Quality adjusted life years will be measured by the SF-6D questionnaire

Sponsors and collaborators

Lead sponsor

Universidade Cidade de Sao Paulo

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 16, 2014
Registry last updated
Sep 6, 2017

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.

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